Multiple SclerosisEMMANCT06105463
Multiple Sclerosis, Menstrual Cycle and Physical Acivity
A study testing Strength training sessions and High-interval intensity training sessions in people with Multiple Sclerosis, run by Universidad de Almeria at 1 site in Spain.
Trial summary
This study aims to identify moderating variables that modify satisfaction with physical activity practice throughout the menstrual cycle (MC) in women with and without multiple sclerosis (MS) during High-Intensity Interval Training (HIIT) and strength training sessions, and to compare the acute effects of different… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Strength training sessions and High-interval intensity training sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women aged between 18-40 years;
- women with a menstrual cycle length of ≥ 21 days and ≤ 35 days of natural menstruation;
- absence of iron deficiency anaemia (serum ferritin > 20 μg/L, hemoglobin > 115 μg/L, transferrin saturation > 16%)
- being in a stable phase of the disease,
- to ambulate autonomously for more than 100 meters
Who cannot join
- a score < 2 or > 6 on the Expanded Disability Status Scale (EDSS);
- experienced a relapse in the 12 months prior to enrolment;
- received corticosteroid treatment in the previous 2 months;
- participated in a structured exercise programme in the past 6 months;
- secondary amenorrhoea (absence of ≥ 3 consecutive periods despite not being pregnant and having previous menstruation);
- used or currently use hormonal contraceptives for 3 months before recruitment
- reported musculoskeletal or neurological injuries not associated with MS, recent surgical interventions, or pregnancies in the previous year,
- have unrelated diseases to MS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Response to Physical Activity in Women With Multiple Sclerosis Throughout the Menstrual Cycle (EMMA Project)
This study aims to identify moderating variables that modify satisfaction with physical activity practice throughout the menstrual cycle (MC) in women with and without multiple sclerosis (MS) during High-Intensity Interval Training (HIIT) and strength training sessions, and to compare the acute effects of different types of physical activity sessions in women with and without MS. This study used a randomized crossover trial study and single-blind performed by women with MS, matched 1:1 based on age, lifestyle factors and country of residence, with women without MS to analyse the effect of physical activity practise on satisfaction, functionality, fatigue, and inflammatory profile throughout MC. Participants will visit the facilities approximately 10 times (4 preliminary familiarization visits and 6 visits to carry out a physical activity session in each phase of the MC) over a period of 3-4 months. Evaluation will comprise clinical, nutritional and psychological interviews including different variables such as satisfaction on physical activity; visual analogue scale of fatigue; abdominal obesity and anthropometric variables; dietary and nutritional monitoring; bioimpedance analysis; blood profile of hormone, inflammatory and cognitive function blood profile; neuromuscular strength, voluntary activation, and contractile properties; functional assessment (spasticity, knee angles, gait speed, walking endurance, balance, sit-to-stand test, timed up and go test); rating of perceived exertion; pain; muscle oxygen saturation; lactate; heart rate variability; quality of sleep and life; and body temperature. During the luteal phase, women with MS are expected to exhibit different acute responses to HIIT and strength training sessions compared to women without the disease.
- Conditions
- Multiple Sclerosis
- Being tested
- Strength training sessions and High-interval intensity training sessions
- Keywords
- strength training, High-Intensity Interval Training, Physical activity satisfaction, quality of life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training sessions and High-interval intensity training sessionsOther
During strength training sessions, participants will perform 4 lower limb exercises, including bilateral leg press, unilateral leg extension, unilateral hip extension, and bilateral seated calf raise on conventional weight machines. The intensity of the session will be 70-75% of 1-RM, 4 sets, 10 repetitions (1-2 RIR) and 120 seconds rest between sets.
During High-interval intensity training (HIIT) sessions, participants will perform 10 minutes of warm-up at 50% of peak power + 20 minutes of HIIT consisting of 30 seconds at 90% of peak power followed by 30 seconds of rest + 10 minutes of cool-down at 35-40% of peak power in cycloergometer.
| Study group | Role | What they receive |
|---|---|---|
| Women with Multiple Sclerosis | Experimental | Women diagnosed with Multiple Sclerosis by a certified neurologist Receives: Other: Strength training sessions and High-interval intensity training sessions |
| Women without Multiple Sclerosis | Active comparator | Women not diagnosed with multiple sclerosis Receives: Other: Strength training sessions and High-interval intensity training sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with physical activity
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Measured: Before sessions (strength and High-interval intensity training session)
Satisfaction with physical activity
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Satisfaction with physical activity
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Measured: 24 hours after sessions (strength and High-interval intensity training session)
Satisfaction with physical activity
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Measured: 48 hours after sessions (strength and High-interval intensity training session)
Satisfaction with physical activity
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Measured: 72 hours after sessions (strength and High-interval intensity training session)
Visual analog scale of fatigue (VAS-F)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
Measured: Before sessions (strength and High-interval intensity training session)
Visual analog scale of fatigue (VAS-F)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Visual analog scale of fatigue (VAS-F)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
Measured: 24 hours after sessions (strength and High-interval intensity training session)
Visual analog scale of fatigue (VAS-F)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
Measured: 48 hours after sessions (strength and High-interval intensity training session)
Visual analog scale of fatigue (VAS-F)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
Measured: 72 hours after sessions (strength and High-interval intensity training session)
Secondary outcomes (66)
Subjective Sleep Quality Questionnaire
Subjective sleep quality will be measured using the Karolinska Sleep Diary questionnarie. The questionnaire includes the following items: a) sleep quality (very poor [1] - very good [5]), b) sleep tranquility (very restless [1] - very calm [5]), c) ease of falling asleep (very difficult [1] - very easy [5]), d) awakenings (awakened much too early [1] - did not wake up early [3]), e) ease of awakening (very difficult [1] - very easy [5]), f) feeling of restfulness (did not rest at all [1] - completely rested [3]), and g) sleep sufficiency (no, definitely too little [1] - yes, definitely enough [5]).
Measured: Before sessions (strength and High-interval intensity training session)
Subjective Sleep Quality Questionnaire
Subjective sleep quality will be measured using the Karolinska Sleep Diary questionnarie. The questionnaire includes the following items: a) sleep quality (very poor [1] - very good [5]), b) sleep tranquility (very restless [1] - very calm [5]), c) ease of falling asleep (very difficult [1] - very easy [5]), d) awakenings (awakened much too early [1] - did not wake up early [3]), e) ease of awakening (very difficult [1] - very easy [5]), f) feeling of restfulness (did not rest at all [1] - completely rested [3]), and g) sleep sufficiency (no, definitely too little [1] - yes, definitely enough [5]).
Measured: Immediately after sessions (strength and High-interval intensity training session)
Subjective Sleep Quality Questionnaire
Subjective sleep quality will be measured using the Karolinska Sleep Diary questionnarie. The questionnaire includes the following items: a) sleep quality (very poor [1] - very good [5]), b) sleep tranquility (very restless [1] - very calm [5]), c) ease of falling asleep (very difficult [1] - very easy [5]), d) awakenings (awakened much too early [1] - did not wake up early [3]), e) ease of awakening (very difficult [1] - very easy [5]), f) feeling of restfulness (did not rest at all [1] - completely rested [3]), and g) sleep sufficiency (no, definitely too little [1] - yes, definitely enough [5]).
Measured: 24 hours after sessions (strength and High-interval intensity training session)
Subjective Sleep Quality Questionnaire
Subjective sleep quality will be measured using the Karolinska Sleep Diary questionnarie. The questionnaire includes the following items: a) sleep quality (very poor [1] - very good [5]), b) sleep tranquility (very restless [1] - very calm [5]), c) ease of falling asleep (very difficult [1] - very easy [5]), d) awakenings (awakened much too early [1] - did not wake up early [3]), e) ease of awakening (very difficult [1] - very easy [5]), f) feeling of restfulness (did not rest at all [1] - completely rested [3]), and g) sleep sufficiency (no, definitely too little [1] - yes, definitely enough [5]).
Measured: 48 hours after sessions (strength and High-interval intensity training session)
Subjective Sleep Quality Questionnaire
Subjective sleep quality will be measured using the Karolinska Sleep Diary questionnarie. The questionnaire includes the following items: a) sleep quality (very poor [1] - very good [5]), b) sleep tranquility (very restless [1] - very calm [5]), c) ease of falling asleep (very difficult [1] - very easy [5]), d) awakenings (awakened much too early [1] - did not wake up early [3]), e) ease of awakening (very difficult [1] - very easy [5]), f) feeling of restfulness (did not rest at all [1] - completely rested [3]), and g) sleep sufficiency (no, definitely too little [1] - yes, definitely enough [5]).
Measured: 72 hours after sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Actigraphy-based sleep quality will be assessed using the Actiwatch wGT3X-BT activity monitoring system (Cambridge Neurotechnology, Cambridge, UK). This device employs a piezoelectric accelerometer to measure activity. Participants will wear the Actiwatch on their non-dominant wrist. The lower threshold of actigraphic sensitivity will be set at 80 counts/epoch. The Actiwatch sleep analysis software will be utilized. Data analysis will begin at the start of the nocturnal rest (bedtime) and conclude at the beginning of daytime activity (wake time). Sleep efficiency (%), percentage of time spent asleep, time in bed (minutes), actual sleep time (minutes), actual wake time (minutes), number of awakenings, and average duration of each awakening (minutes) will be measured
Measured: Before sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Actigraphy-based sleep quality will be assessed using the Actiwatch wGT3X-BT activity monitoring system (Cambridge Neurotechnology, Cambridge, UK). This device employs a piezoelectric accelerometer to measure activity. Participants will wear the Actiwatch on their non-dominant wrist. The lower threshold of actigraphic sensitivity will be set at 80 counts/epoch. The Actiwatch sleep analysis software will be utilized. Data analysis will begin at the start of the nocturnal rest (bedtime) and conclude at the beginning of daytime activity (wake time). Sleep efficiency (%), percentage of time spent asleep, time in bed (minutes), actual sleep time (minutes), actual wake time (minutes), number of awakenings, and average duration of each awakening (minutes) will be measured
Measured: Immediately after sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Actigraphy-based sleep quality will be assessed using the Actiwatch wGT3X-BT activity monitoring system (Cambridge Neurotechnology, Cambridge, UK). This device employs a piezoelectric accelerometer to measure activity. Participants will wear the Actiwatch on their non-dominant wrist. The lower threshold of actigraphic sensitivity will be set at 80 counts/epoch. The Actiwatch sleep analysis software will be utilized. Data analysis will begin at the start of the nocturnal rest (bedtime) and conclude at the beginning of daytime activity (wake time). Sleep efficiency (%), percentage of time spent asleep, time in bed (minutes), actual sleep time (minutes), actual wake time (minutes), number of awakenings, and average duration of each awakening (minutes) will be measured
Measured: 24 hours after sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Actigraphy-based sleep quality will be assessed using the Actiwatch wGT3X-BT activity monitoring system (Cambridge Neurotechnology, Cambridge, UK). This device employs a piezoelectric accelerometer to measure activity. Participants will wear the Actiwatch on their non-dominant wrist. The lower threshold of actigraphic sensitivity will be set at 80 counts/epoch. The Actiwatch sleep analysis software will be utilized. Data analysis will begin at the start of the nocturnal rest (bedtime) and conclude at the beginning of daytime activity (wake time). Sleep efficiency (%), percentage of time spent asleep, time in bed (minutes), actual sleep time (minutes), actual wake time (minutes), number of awakenings, and average duration of each awakening (minutes) will be measured
Measured: 48 hours after sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Actigraphy-based sleep quality will be assessed using the Actiwatch wGT3X-BT activity monitoring system (Cambridge Neurotechnology, Cambridge, UK). This device employs a piezoelectric accelerometer to measure activity. Participants will wear the Actiwatch on their non-dominant wrist. The lower threshold of actigraphic sensitivity will be set at 80 counts/epoch. The Actiwatch sleep analysis software will be utilized. Data analysis will begin at the start of the nocturnal rest (bedtime) and conclude at the beginning of daytime activity (wake time). Sleep efficiency (%), percentage of time spent asleep, time in bed (minutes), actual sleep time (minutes), actual wake time (minutes), number of awakenings, and average duration of each awakening (minutes) will be measured
Measured: 72 hours after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Heart rate variability (HRV) measurements will be taken using a Polar H10 heart rate sensor to record heartbeats during sleep. Analysis of HRV variables will be conducted using Kubios HRV software. Poincaré plot, time-domain, and frequency-domain analyses will be performed. Analysed time-domain variables include:: mean heart rate, mean R-R interval, standard deviation of consecutive R-R intervals, square root of the mean squared differences of successive R-R intervals, and the proportion of consecutive intervals differing by more than 50 ms. Fast Fourier Transform (FFT) will be employed to calculate frequency-domain spectral components. High-frequency (HF; 0.15-1.0 Hz) and low-frequency (LF; 0.04-0.15 Hz) power components will be computed as integrals of their respective power spectral density curves.
Measured: Before sessions (strength and High-interval intensity training session)
Heart Rate Variability
Heart rate variability (HRV) measurements will be taken using a Polar H10 heart rate sensor to record heartbeats during sleep. Analysis of HRV variables will be conducted using Kubios HRV software. Poincaré plot, time-domain, and frequency-domain analyses will be performed. Analysed time-domain variables include:: mean heart rate, mean R-R interval, standard deviation of consecutive R-R intervals, square root of the mean squared differences of successive R-R intervals, and the proportion of consecutive intervals differing by more than 50 ms. Fast Fourier Transform (FFT) will be employed to calculate frequency-domain spectral components. High-frequency (HF; 0.15-1.0 Hz) and low-frequency (LF; 0.04-0.15 Hz) power components will be computed as integrals of their respective power spectral density curves.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Heart rate variability (HRV) measurements will be taken using a Polar H10 heart rate sensor to record heartbeats during sleep. Analysis of HRV variables will be conducted using Kubios HRV software. Poincaré plot, time-domain, and frequency-domain analyses will be performed. Analysed time-domain variables include:: mean heart rate, mean R-R interval, standard deviation of consecutive R-R intervals, square root of the mean squared differences of successive R-R intervals, and the proportion of consecutive intervals differing by more than 50 ms. Fast Fourier Transform (FFT) will be employed to calculate frequency-domain spectral components. High-frequency (HF; 0.15-1.0 Hz) and low-frequency (LF; 0.04-0.15 Hz) power components will be computed as integrals of their respective power spectral density curves.
Measured: 24 hours after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Heart rate variability (HRV) measurements will be taken using a Polar H10 heart rate sensor to record heartbeats during sleep. Analysis of HRV variables will be conducted using Kubios HRV software. Poincaré plot, time-domain, and frequency-domain analyses will be performed. Analysed time-domain variables include:: mean heart rate, mean R-R interval, standard deviation of consecutive R-R intervals, square root of the mean squared differences of successive R-R intervals, and the proportion of consecutive intervals differing by more than 50 ms. Fast Fourier Transform (FFT) will be employed to calculate frequency-domain spectral components. High-frequency (HF; 0.15-1.0 Hz) and low-frequency (LF; 0.04-0.15 Hz) power components will be computed as integrals of their respective power spectral density curves.
Measured: 48 hours after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Heart rate variability (HRV) measurements will be taken using a Polar H10 heart rate sensor to record heartbeats during sleep. Analysis of HRV variables will be conducted using Kubios HRV software. Poincaré plot, time-domain, and frequency-domain analyses will be performed. Analysed time-domain variables include:: mean heart rate, mean R-R interval, standard deviation of consecutive R-R intervals, square root of the mean squared differences of successive R-R intervals, and the proportion of consecutive intervals differing by more than 50 ms. Fast Fourier Transform (FFT) will be employed to calculate frequency-domain spectral components. High-frequency (HF; 0.15-1.0 Hz) and low-frequency (LF; 0.04-0.15 Hz) power components will be computed as integrals of their respective power spectral density curves.
Measured: 72 hours after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Heart rate variability (HRV) measurements will be taken using a Polar H10 heart rate sensor to record heartbeats during sleep. Analysis of HRV variables will be conducted using Kubios HRV software. Poincaré plot, time-domain, and frequency-domain analyses will be performed. Analysed time-domain variables include:: mean heart rate, mean R-R interval, standard deviation of consecutive R-R intervals, square root of the mean squared differences of successive R-R intervals, and the proportion of consecutive intervals differing by more than 50 ms. Fast Fourier Transform (FFT) will be employed to calculate frequency-domain spectral components. High-frequency (HF; 0.15-1.0 Hz) and low-frequency (LF; 0.04-0.15 Hz) power components will be computed as integrals of their respective power spectral density curves.
Measured: During sessions (strength and High-interval intensity training session)
Muscle oxygen saturation
SMO2 of the right and left lateral quadriceps will be measured during sessions using a near-infrared spectroscopy system, the Moxy 3-Sensor Bundle (Fortiori Design LLC, Hutchinson, MN, USA). The average SMO2 will be calculated throughout the entire training session on both legs simultaneously.
Measured: During sessions (strength and High-interval intensity training session)
Lactate
A portable lactate analyser (Lactate Scout system, RedMed, Warsaw, Poland) which measures lactate concentration using the principle of enzymatic determination by photometric reflection will be used. During the exercise sessions, capillary blood samples from the will be collected 1) at basal level (before the protocol and warm-up); 2) 1 min post-session (1 min after the end of the last high-intensity bout), 3) 3 min post-session and 4) 30 min post-session.
Measured: During sessions (strength and High-interval intensity training session)
Maximum oxygen consumption
The maximum oxygen consumption achieved during an incremental test to exhaustion shall be measured using an ergo-spirometer.
Measured: During sessions (strength and High-interval intensity training session)
Body composition
Bioimpedance analysis: 100 μA (1 KHz) and 500 μA (5, 5, 50, 250, 500, and 1000 kHz), and a 100-240 V
Measured: Before sessions (strength and High-interval intensity training session)
Body composition
Bioimpedance analysis: 100 μA (1 KHz) and 500 μA (5, 5, 50, 250, 500, and 1000 kHz), and a 100-240 V
Measured: Immediately after sessions (strength and High-interval intensity training session)
Hormonal profile
To determine and monitor sexual function according to the menstrual cycle hormone criteria, serum hormone concentrations will be analysed, and 17β-estradiol, progesterone, prolactin, LH, FSH, TSH and testosterone 23 before each training session.
Measured: Before sessions (strength and High-interval intensity training session)
Hormonal profile
To determine and monitor sexual function according to the menstrual cycle hormone criteria, serum hormone concentrations will be analysed, and 17β-estradiol, progesterone, prolactin, LH, FSH, TSH and testosterone 23 before each training session.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Inflammatory profile
IFN-γ as a marker associated with the pathogenesis of the disease, IL-6, TNF-α as pro-inflammatory markers and IL-10, β1 (TGF-b1) as anti-inflammatory markers will be assessed. All these markers shall be assessed before and at 30 and 60 minutes immediately after the session.
Measured: Before sessions (strength and High-interval intensity training session)
Inflammatory profile
IFN-γ as a marker associated with the pathogenesis of the disease, IL-6, TNF-α as pro-inflammatory markers and IL-10, β1 (TGF-b1) as anti-inflammatory markers will be assessed. All these markers shall be assessed before and at 30 and 60 minutes immediately after the session.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Cognitive function
Brain-derived neurotrophic factor (BDNF) is a member of the neurotrophin family, several studies have found associations between exercise, circulating levels of BDNF, hippocampal volume, and cognitive function in the general population 74 and neurodegenerative disorders.
Measured: Before sessions (strength and High-interval intensity training session)
Cognitive function
Brain-derived neurotrophic factor (BDNF) is a member of the neurotrophin family, several studies have found associations between exercise, circulating levels of BDNF, hippocampal volume, and cognitive function in the general population 74 and neurodegenerative disorders.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Rate of force development
the participants will be seated in a chair, with both legs flexed at a 90 degree angle and the ankle of the tested firmly strapped to a customised device with a load cell (MuscleLab Force Sensor, Ergotest AS, Langesund, Norway). Subsequently, participants will be instructed to apply "as much force as possible, as fast as possible" on each trial. Participants will perform three maximal contractions of two seconds each, with a rest of three minutes between contractions.RFD and the time at which the value is observed will be analysed in the following ranges: 0-50 ms: RFDearly, 0-200 ms: RFDlate and peak slope: RFDpeak. The right leg will be tested first, and the repetition in which the highest peak value of each leg is observed will be analysed.
Measured: Before sessions (strength and High-interval intensity training session)
Rate of force development
the participants will be seated in a chair, with both legs flexed at a 90 degree angle and the ankle of the tested firmly strapped to a customised device with a load cell (MuscleLab Force Sensor, Ergotest AS, Langesund, Norway). Subsequently, participants will be instructed to apply "as much force as possible, as fast as possible" on each trial. Participants will perform three maximal contractions of two seconds each, with a rest of three minutes between contractions. RFD and the time at which the value is observed will be analysed in the following ranges: 0-50 ms: RFDearly, 0-200 ms: RFDlate and peak slope: RFDpeak. The right leg will be tested first, and the repetition in which the highest peak value of each leg is observed will be analysed.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Maximal Voluntary Activation
the participants will be seated in a chair, with both legs flexed at a 90 degree angle and the ankle of the tested firmly strapped to a customised device with a load cell (MuscleLab Force Sensor, Ergotest AS, Langesund, Norway). Subsequently, participants will be instructed to apply "as much force as possible, as fast as possible" on each trial. Participants will perform three maximal contractions of two seconds each, with a rest of three minutes between contractions.
Measured: Before sessions (strength and High-interval intensity training session)
Maximal Voluntary Activation
the participants will be seated in a chair, with both legs flexed at a 90 degree angle and the ankle of the tested firmly strapped to a customised device with a load cell (MuscleLab Force Sensor, Ergotest AS, Langesund, Norway). Subsequently, participants will be instructed to apply "as much force as possible, as fast as possible" on each trial. Participants will perform three maximal contractions of two seconds each, with a rest of three minutes between contractions.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Contractile properties of muscle
To measure neural drive, sEMG activity of the vastus lateralis of the right leg will be recorded during the MVIC. The preparation of the skin will involve shaving, abrasion, and cleansing with alcohol. Following SENIAM Guidelines, the upper electrode of each pair (Ambu Blue Sensor SP, Ambu A/S, Denmark) will be placed over the largest part of the vastus lateralis. Transparent paper will be used to map exact electrode placements for subsequent measurements. EMG activity will be analysed using the following time intervals: 0-50 ms (EMG 0 to 50), 0 to 200 ms (EMG 0 to 200), peak of EMG and EMG time-to-peak. The EMG peak during MVIC will represent maximal neural drive.
Measured: Before sessions (strength and High-interval intensity training session)
Contractile properties of muscle
To measure neural drive, sEMG activity of the vastus lateralis of the right leg will be recorded during the MVIC. The preparation of the skin will involve shaving, abrasion, and cleansing with alcohol. Following SENIAM Guidelines, the upper electrode of each pair (Ambu Blue Sensor SP, Ambu A/S, Denmark) will be placed over the largest part of the vastus lateralis. Transparent paper will be used to map exact electrode placements for subsequent measurements. EMG activity will be analysed using the following time intervals: 0-50 ms (EMG 0 to 50), 0 to 200 ms (EMG 0 to 200), peak of EMG and EMG time-to-peak. The EMG peak during MVIC will represent maximal neural drive.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Central activation ratio
Two bipolar stimulating electrodes (10 × 15 cm) will be positioned and secured on the proximal and distal portions of the quadriceps of the right leg. Signal 6.0 software (CED, Cambridge, England) will control the electrical stimulation characteristics, which will be 100 Hz, 50 pulses, length 0.009 s, and interval 0.01 s. The stimulus intensity will be established at 40-50% of MVIC
Measured: Before sessions (strength and High-interval intensity training session)
Central activation ratio
Two bipolar stimulating electrodes (10 × 15 cm) will be positioned and secured on the proximal and distal portions of the quadriceps of the right leg. Signal 6.0 software (CED, Cambridge, England) will control the electrical stimulation characteristics, which will be 100 Hz, 50 pulses, length 0.009 s, and interval 0.01 s. The stimulus intensity will be established at 40-50% of MVIC
Measured: Immediately after sessions (strength and High-interval intensity training session)
Maximal upper limb strength
): Participants will stand with their elbows fully extended and separated from the trunk. In this position, isometric handgrip strength will be measured for 5 seconds using the electronic hand dynamometer (TL-LSC100, Trailite, Ahaus, Germany). Participants will perform three trials in each hand (right and left), and a rest interval of 60 seconds will be given between attempts. The highest value achieved will be recorded.
Measured: Before sessions (strength and High-interval intensity training session)
Maximal upper limb strength
): Participants will stand with their elbows fully extended and separated from the trunk. In this position, isometric handgrip strength will be measured for 5 seconds using the electronic hand dynamometer (TL-LSC100, Trailite, Ahaus, Germany). Participants will perform three trials in each hand (right and left), and a rest interval of 60 seconds will be given between attempts. The highest value achieved will be recorded.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Spasticity
The pendulum test will be used for spasticity assessment. Metrics including the relaxation index (RI), the count of oscillations, duration of oscillations, and the extent of the first swing excursion will be computed.
Measured: Before sessions (strength and High-interval intensity training session)
Spasticity
The pendulum test will be used for spasticity assessment. Metrics including the relaxation index (RI), the count of oscillations, duration of oscillations, and the extent of the first swing excursion will be computed.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Gait speed
Gait speed will be measured using the 10-meter walk test (10-MWT), where 2 photocells (Ergotest Technology AS, Langesund, Norway) will be placed at 6 and 10 meters to record the time. Participants will perform the test as fast as possible without running, completing it twice with a 2-minute rest in between. Participants will be consistently encouraged throughout the 10-MWT. The recorded time for the slowest walking trial (in seconds) will be utilized for analysis
Measured: Before sessions (strength and High-interval intensity training session)
Gait speed
Gait speed will be measured using the 10-meter walk test (10-MWT), where 2 photocells (Ergotest Technology AS, Langesund, Norway) will be placed at 6 and 10 meters to record the time. Participants will perform the test as fast as possible without running, completing it twice with a 2-minute rest in between. Participants will be consistently encouraged throughout the 10-MWT. The recorded time for the slowest walking trial (in seconds) will be utilized for analysis
Measured: Immediately after sessions (strength and High-interval intensity training session)
Balance
during the static balance measurements, participants will stand quietly on a portable force platform (Ergotest Technology AS, Langesund, Norway) while being barefoot, maintaining a shoulder-width stance, and letting their arms hang at their sides. Each participant will perform two trials lasting 30 seconds each, with both eyes open, and another two trials of the same duration with their eyes closed.
Measured: Before sessions (strength and High-interval intensity training session)
Balance
during the static balance measurements, participants will stand quietly on a portable force platform (Ergotest Technology AS, Langesund, Norway) while being barefoot, maintaining a shoulder-width stance, and letting their arms hang at their sides. Each participant will perform two trials lasting 30 seconds each, with both eyes open, and another two trials of the same duration with their eyes closed.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Sit-to-Stand Test (STS)
Participants will be positioned in an upright manner on an adjustable chair (considering lower limb length; 90º knee flexion) with arms crossed over the chest. They will be instructed to rise to a standing position as swiftly as possible. Video recording with iphone 14 will be employed to determine the conclusion of the movement when both the participant's trunk and knees are fully extended. This test will be conducted twice, and the most successful trial will be utilized for analysis.
Measured: Before sessions (strength and High-interval intensity training session)
Sit-to-Stand Test (STS)
Participants will be positioned in an upright manner on an adjustable chair (considering lower limb length; 90º knee flexion) with arms crossed over the chest. They will be instructed to rise to a standing position as swiftly as possible. Video recording with iphone 14 will be employed to determine the conclusion of the movement when both the participant's trunk and knees are fully extended. This test will be conducted twice, and the most successful trial will be utilized for analysis.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Timed Up and Go Test (TUG)
In a prompt manner, participants will transition from a seated to a standing position. They will then walk a distance of 3 meters forward, execute a turn, walk back, and resume the seated posture. This test will be repeated twice. A video recording will be used to ascertain the fastest time among the two trials, which will subsequently be used for analysis
Measured: Before sessions (strength and High-interval intensity training session)
Timed Up and Go Test (TUG)
In a prompt manner, participants will transition from a seated to a standing position. They will then walk a distance of 3 meters forward, execute a turn, walk back, and resume the seated posture. This test will be repeated twice. A video recording will be used to ascertain the fastest time among the two trials, which will subsequently be used for analysis
Measured: Immediately after sessions (strength and High-interval intensity training session)
Rating of Perceived Exertion (RPE)
Participants will be instructed and familiarized with the use of the RPE scale during the familiarization phase. RPE will be assessed before, during (after each of the proposed exercises within the session), and after the training session using the Borg 6-20 RPE
Measured: Before sessions (strength and High-interval intensity training session)
Rating of Perceived Exertion (RPE)
Participants will be instructed and familiarized with the use of the RPE scale during the familiarization phase. RPE will be assessed before, during (after each of the proposed exercises within the session), and after the training session using the Borg 6-20 RPE
Measured: Immediately after sessions (strength and High-interval intensity training session)
Delayed-Onset Muscle Soreness (DOMS)
a 10-point Likert scale will be employed to evaluate pain, where 1 = no pain and 10 = unbearable pain.
Measured: Before sessions (strength and High-interval intensity training session)
Delayed-Onset Muscle Soreness (DOMS)
a 10-point Likert scale will be employed to evaluate pain, where 1 = no pain and 10 = unbearable pain.
Measured: Immediately after sessions (strength and High-interval intensity training session)
Muscle pain sensitivity
an algometer FPIX (Wagner's instruments, USA) will be used to quantify pain sensitivity in specific muscle regions (same anatomical areas where spasticity is measured). The algometer will be calibrated according to the manufacturer's guidelines. Participants will be instructed to indicate their initial pain threshold. The rounded tip of the algometer will ensure an even application of pressure
Measured: Before sessions (strength and High-interval intensity training session)
Muscle pain sensitivity
an algometer FPIX (Wagner's instruments, USA) will be used to quantify pain sensitivity in specific muscle regions (same anatomical areas where spasticity is measured). The algometer will be calibrated according to the manufacturer's guidelines. Participants will be instructed to indicate their initial pain threshold. The rounded tip of the algometer will ensure an even application of pressure
Measured: Immediately after sessions (strength and High-interval intensity training session)
Fat mass
The percentage of body fat (%) and the kilograms of fat mass (kg) of the participants will be obtained using the ISAK method of anthropometric profiling.
Measured: Baseline Measurements
Muscle mass
The percentage of muscle mass (%) and the kilograms of muscle mass (kg) of the participants will be obtained using the ISAK method of anthropometric profiling.
Measured: Baseline Measurements
Bone mass
The percentage of bone mass (%) and the kilograms of bone mass (kg) of the participants will be obtained using the ISAK method of anthropometric profiling.
Measured: Baseline Measurements
Dietary and nutritional monitoring
Following the outlined schedule for dietary assessment, participants will be guided through the core elements of the "Dietary and Nutritional Monitoring Protocol."
Measured: Baseline Measurements
Physical activity levels
The International Physical Activity Questionnaire (IPAQ) will be administered. The telephone short version consisting of 7 items will be utilized. This version provides information about the time spent on performing moderate and vigorous-intensity activities, time dedicated to walking, and time spent sitting during a workday. It is designed for use with young people and adults aged 15-69 years. Physical activity will be recorded in METs (Metabolic Equivalent of Task or METs Units)
Measured: Baseline measurements
Physical activity levels
The International Physical Activity Questionnaire (IPAQ) will be administered. The telephone short version consisting of 7 items will be utilized. This version provides information about the time spent on performing moderate and vigorous-intensity activities, time dedicated to walking, and time spent sitting during a workday. It is designed for use with young people and adults aged 15-69 years. Physical activity will be recorded in METs (Metabolic Equivalent of Task or METs Units)
Measured: 7 days after the end of the study
Walking endurance
Participants will undergo the 6-minute walk test (6-MWT), during which they will walk at their self-selected preferred speed to assess walking endurance. The testing track will be rectangular, with corners marked by cones. Participants will be allowed to rest during the test if needed, but the time will not pause during these resting periods. The total distance covered (in meters) will be recorded. An investigator will be present during the test to accompany the participants, though no conversation will occur. This test will only be performed during baseline evaluations.
Measured: Baseline measurements
Physical self-perception
The evaluation of physical self-perception will comprise six subscales aimed at gauging self-perception in various dimensions, including sports competence, physical condition, attractive body, physical strength, general physical self-perception, and general self-perception. Participants' responses will be organized using a 5-point Likert scale, with each subscale score having the potential to span from 6 to 36 points. A higher score will indicate a positive physical self-perception.
Measured: Through study completion, an average of 3 times per month, up to 10 weeks.
Catastrophizing Pain Scale
The Catastrophizing Pain Scale will be used to assess feelings of catastrophizing related to pain (such as painful experiences). Subscale scores encompassing rumination and helplessness will be examined. Each of the 13 questions will be rated on a 5-point scale, with the endpoints ranging from <0> "not at all" to <4> "all the time." A lower score will indicate minimal or no pain catastrophizing.
Measured: Through study completion, an average of 3 times per month, up to 10 weeks.
Modified Fatigue Impact Scale (MFIS)
The perception of fatigue will be measured using the MFIS, this scale is a 21-item multidimensional questionnaire that assesses the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84).
Measured: Through study completion, an average of 3 times per month, up to 10 weeks.
Multiple Sclerosis Quality of Life-54 (MSQoL-54)
Participants will be filled out the Multiple Sclerosis Quality of Life-54 (MSQoL-54) questionnaire. The MSQoL-54 is a structured, self-report questionnaire comprising 14 sub-scales: physical function, physical role limitations, emotional role limitations, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, sexual function, satisfaction with sexual function, change in health, and overall quality of life. Two summary scores, the physical health composite summary and the mental health composite summary, can be derived from the MSQoL-54 questionnaire. Elevated scores in each subscale or summary score will indicate an improved quality of life.
Measured: Through study completion, an average of 3 times per month, up to 10 weeks.
State anxiety and trait anxiety (STAI)
The STAI will be used to measure state and trait anxiety. This questionnaire assesses and discriminates the temporary psychological state in a given situation (state anxiety; 20 items), as well as the more stable character trait of attitudes and temperaments (trait anxiety; 20 items). This questionnaire is especially useful for the diagnosis of anxiety problems in non-psychiatric patients. It is based on a 4-point Likert scale, with a range of scores on each subscale from 10 to 40 points. A higher score on each of the subscales reflects higher state or trait anxiety, respectively.
Measured: Through study completion, an average of 3 times per month, up to 10 weeks.
Body temperature
To capture thermal images, a PIR UC 605 thermographic camera (Infratec, Barcelona, Spain) will be used, equipped with an impressive infrared resolution of 640 x 480 pixels and an impressive thermal sensitivity of less than 0.06 ºC. Calibration of the camera will be conducted according to the manufacturer's recommendations, as well as recommendations from previous studies. The camera will be connected at least 30 min prior to all evaluations to allow stabilisation of its thermal sensor.
Three measurements shall be performed following the Glamorgan protocol, designed to provide accurate measurements of body thermography
Measured: Through study completion, an average of 3 times per month, up to 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start6 May 2024
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An randomized crossover trial and single-blind.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobo Á. Rubio-Arias, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105463
- Sponsor's protocol ID
- UALBIO2022/048
- Other IDs
- EXP_75066
- Acronym
- EMMA
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rubio-Arias JA, Ramos-Campo DJ, Romero-Parra N, Andreu-Caravaca L, Martinez-Rodriguez A, Esteban-Garcia P, Lopez-Liria R, Molina-Torres G, Ventura-Miranda MI, Martos-Bonilla A, Rando-Martin A, Carrasco-Poyatos M, Alacid F, Ferrer-Contreras MDC, Cupeiro R. Response to physical activity of females with multiple sclerosis throughout the menstrual cycle: a protocol for a randomised crossover trial (EMMA Project). BMJ Open Sport Exerc Med. 2023 Nov 21;9(4):e001797. doi: 10.1136/bmjsem-2023-001797. eCollection 2023.
PubMed 38022757
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Physical Activity in Women With Multiple Sclerosis Throughout the Menstrual Cycle (EMMA Project)
- ClinicalTrials.gov ID
- NCT06105463
- Acronym / sponsor ID
- EMMA / UALBIO2022/048
- Conditions
- Multiple Sclerosis
- Keywords
- strength training, High-Intensity Interval Training, Physical activity satisfaction, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify moderating variables that modify satisfaction with physical activity practice throughout the menstrual cycle (MC) in women with and without multiple sclerosis (MS) during High-Intensity Interval Training (HIIT) and strength training sessions, and to compare the acute effects of different types of physical activity sessions in women with and without MS. This study used a randomized crossover trial study and single-blind performed by women with MS, matched 1:1 based on age, lifestyle factors and country of residence, with women without MS to analyse the effect of physical activity practise on satisfaction, functionality, fatigue, and inflammatory profile throughout MC. Participants will visit the facilities approximately 10 times (4 preliminary familiarization visits and 6 visits to carry out a physical activity session in each phase of the MC) over a period of 3-4 months. Evaluation will comprise clinical, nutritional and psychological interviews including different variables such as satisfaction on physical activity; visual analogue scale of fatigue; abdominal obesity and anthropometric variables; dietary and nutritional monitoring; bioimpedance analysis; blood profile of hormone, inflammatory and cognitive function blood profile; neuromuscular strength, voluntary activation, and contractile properties; functional assessment (spasticity, knee angles, gait speed, walking endurance, balance, sit-to-stand test, timed up and go test); rating of perceived exertion; pain; muscle oxygen saturation; lactate; heart rate variability; quality of sleep and life; and body temperature. During the luteal phase, women with MS are expected to exhibit different acute responses to HIIT and strength training sessions compared to women without the disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An randomized crossover trial and single-blind.
| Arm | Type | Receives |
|---|---|---|
| Women with Multiple Sclerosis | Experimental | Other: Strength training sessions and High-interval intensity training sessionsWomen diagnosed with Multiple Sclerosis by a certified neurologist |
| Women without Multiple Sclerosis | Active comparator | Other: Strength training sessions and High-interval intensity training sessionsWomen not diagnosed with multiple sclerosis |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women aged between 18-40 years;
- women with a menstrual cycle length of ≥ 21 days and ≤ 35 days of natural menstruation;
- absence of iron deficiency anaemia (serum ferritin > 20 μg/L, hemoglobin > 115 μg/L, transferrin saturation > 16%)
- being in a stable phase of the disease,
- to ambulate autonomously for more than 100 meters
Key exclusion criteria (8 listed)
- a score < 2 or > 6 on the Expanded Disability Status Scale (EDSS);
- experienced a relapse in the 12 months prior to enrolment;
- received corticosteroid treatment in the previous 2 months;
- participated in a structured exercise programme in the past 6 months;
- secondary amenorrhoea (absence of ≥ 3 consecutive periods despite not being pregnant and having previous menstruation);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength training sessions and High-interval intensity training sessionsDuring strength training sessions, participants will perform 4 lower limb exercises, including bilateral leg press, unilateral leg extension, unilateral hip extension, and bilateral seated calf raise on conventional weight machines. The intensity of the session will be 70-75% of 1-RM, 4 sets, 10 repetitions (1-2 RIR) and 120 seconds rest between sets. During High-interval intensity training (HIIT) sessions, participants will perform 10 minutes of warm-up at 50% of peak power + 20 minutes of HIIT consisting of 30 seconds at 90% of peak power followed by 30 seconds of rest + 10 minutes of cool-down at 35-40% of peak power in cycloergometer. | Other | Women with Multiple Sclerosis, Women without Multiple Sclerosis |
Primary outcome
Satisfaction with physical activity
Time frame: Before sessions (strength and High-interval intensity training session)
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Satisfaction with physical activity
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Satisfaction with physical activity
Time frame: 24 hours after sessions (strength and High-interval intensity training session)
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Satisfaction with physical activity
Time frame: 48 hours after sessions (strength and High-interval intensity training session)
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Satisfaction with physical activity
Time frame: 72 hours after sessions (strength and High-interval intensity training session)
Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.
Visual analog scale of fatigue (VAS-F)
Time frame: Before sessions (strength and High-interval intensity training session)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
Visual analog scale of fatigue (VAS-F)
Time frame: Immediately after sessions (strength and High-interval intensity training session)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
Visual analog scale of fatigue (VAS-F)
Time frame: 24 hours after sessions (strength and High-interval intensity training session)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
Visual analog scale of fatigue (VAS-F)
Time frame: 48 hours after sessions (strength and High-interval intensity training session)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
Visual analog scale of fatigue (VAS-F)
Time frame: 72 hours after sessions (strength and High-interval intensity training session)
This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.
66 secondary outcomes
Subjective Sleep Quality Questionnaire
Time frame: Before sessions (strength and High-interval intensity training session)
Subjective Sleep Quality Questionnaire
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Subjective Sleep Quality Questionnaire
Time frame: 24 hours after sessions (strength and High-interval intensity training session)
Subjective Sleep Quality Questionnaire
Time frame: 48 hours after sessions (strength and High-interval intensity training session)
Subjective Sleep Quality Questionnaire
Time frame: 72 hours after sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Time frame: Before sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Time frame: 24 hours after sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Time frame: 48 hours after sessions (strength and High-interval intensity training session)
Sleep Quality Measured by Actigraphy
Time frame: 72 hours after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Time frame: Before sessions (strength and High-interval intensity training session)
Heart Rate Variability
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Time frame: 24 hours after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Time frame: 48 hours after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Time frame: 72 hours after sessions (strength and High-interval intensity training session)
Heart Rate Variability
Time frame: During sessions (strength and High-interval intensity training session)
Muscle oxygen saturation
Time frame: During sessions (strength and High-interval intensity training session)
Lactate
Time frame: During sessions (strength and High-interval intensity training session)
Maximum oxygen consumption
Time frame: During sessions (strength and High-interval intensity training session)
Body composition
Time frame: Before sessions (strength and High-interval intensity training session)
Body composition
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Hormonal profile
Time frame: Before sessions (strength and High-interval intensity training session)
Hormonal profile
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Inflammatory profile
Time frame: Before sessions (strength and High-interval intensity training session)
Inflammatory profile
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Cognitive function
Time frame: Before sessions (strength and High-interval intensity training session)
Cognitive function
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Rate of force development
Time frame: Before sessions (strength and High-interval intensity training session)
Rate of force development
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Maximal Voluntary Activation
Time frame: Before sessions (strength and High-interval intensity training session)
Maximal Voluntary Activation
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Contractile properties of muscle
Time frame: Before sessions (strength and High-interval intensity training session)
Contractile properties of muscle
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Central activation ratio
Time frame: Before sessions (strength and High-interval intensity training session)
Central activation ratio
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Maximal upper limb strength
Time frame: Before sessions (strength and High-interval intensity training session)
Maximal upper limb strength
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Spasticity
Time frame: Before sessions (strength and High-interval intensity training session)
Spasticity
Time frame: Immediately after sessions (strength and High-interval intensity training session)
Gait speed
Time frame: Before sessions (strength and High-interval intensity training session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Derived from this study: PubMed 38022757Rubio-Arias JA, Ramos-Campo DJ, Romero-Parra N, Andreu-Caravaca L, Martinez-Rodriguez A, Esteban-Garcia P, Lopez-Liria R, Molina-Torres G, Ventura-Miranda MI, Martos-Bonilla A, Rando-Martin A, Carrasco-Poyatos M, Alacid F, Ferrer-Contreras MDC, Cupeiro R. Response to physical activity of females with multiple sclerosis throughout the menstrual cycle: a protocol for a randomised crossover trial (EMMA Project). BMJ Open Sport Exerc Med. 2023 Nov 21;9(4):e001797. doi: 10.1136/bmjsem-2023-001797. eCollection 2023.
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training sessions and High-interval intensity training sessions in people with Multiple Sclerosis, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with physical activity (time frame: Before sessions (strength and High-interval intensity training session)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06105463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.