Multiple Sclerosis (MS) - Relapsing-remittingADVICE Phase 2NCT06884579
Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: the ADVICE Protocol Study (Phase 2)
A study testing Strength training, nutrition, and behavioral training and Self-Guided and Unsupervised Program with General Recommendations in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by Universidad de Almeria at 1 site in Spain.
Trial summary
This phase of the project aims to compare in-person, supervised educational programs (EP) with online self-guided EPs in individuals with relapsing-remitting multiple sclerosis. A total of 75 participants will be randomly assigned to one of three groups: a supervised and individualized educational program focused on… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting
- What is being tested?
- Strength training, nutrition, and behavioral training and Self-Guided and Unsupervised Program with General Recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2025to 28 Jul 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Women and men of reproductive age (18-45 years) with MS will be included, with the upper age limit adjusted to reflect the reproductive phase;
- no iron-deficiency anemia;
- stable disease phase;
- independent walking ability for over 10 meters.
- Women will be recruited first and later matched with men based on age, EDSS, and lifestyle habits (physical activity, smoking, and alcohol consumption).
Who cannot join
- score <1 or >6 on the EDSS;
- report a relapse within 12 months before the study begins;
- have taken corticosteroid treatment within the last 2 months;
- have participated in a structured training program in the previous 6 months.
- Once all women with MS are recruited, male participants will be recruited following a 1:1 matching methodology based on age, geographic region, and lifestyle habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study
This phase of the project aims to compare in-person, supervised educational programs (EP) with online self-guided EPs in individuals with relapsing-remitting multiple sclerosis. A total of 75 participants will be randomly assigned to one of three groups: a supervised and individualized educational program focused on HIIT training, a supervised and individualized educational program focused on strength training, and a non-supervised, self-guided educational program based on resistance band training. Additionally, sessions on the Mediterranean diet (both supervised and non-supervised) and cognitive-behavioral interventions will be included. A control evaluation will be conducted three months after the intervention to assess the effects of the educational programs, followed by another evaluation three months later to analyze residual effects. Women who participated in Phase 1 of the study will be invited to take part in this second phase.
- Being tested
- Strength training, nutrition, and behavioral training, Self-Guided and Unsupervised Program with General Recommendations
- Keywords
- Relapsing-Remitting MS, Fatigue, Cognitive Behavioral Therapy, Physical exercise, Dietary habits, Women's Health
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Fatigue, Motor Activity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training, nutrition, and behavioral trainingOther
This arm of the study consists of a supervised strength training program, conducted over 12 weeks with three weekly sessions. The sessions follow a wave-like periodization, with intensities ranging from 70% to 85% of 1-RM. Exercises focus on enhancing neuromuscular strength in the lower limbs, such as leg presses and hip extensions, under the supervision of a multidisciplinary team.
Participants will also receive nutritional guidance based on the Mediterranean diet, as well as cognitive-behavioral therapy strategies aimed at optimizing fatigue management and boosting energy levels.
Self-Guided and Unsupervised Program with General RecommendationsOther
This arm of the study consists of a self-guided and unsupervised program based on physical exercise (3 times per week), nutrition, and cognitive-behavioral habits. Participants will access online modules that provide guidelines for performing resistance exercises with bands, dietary recommendations following the principles of the Mediterranean diet, and cognitive-behavioral techniques for fatigue management.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Strength Training Program (PE1) | Experimental | Participants will complete 36 strength sessions (3 times a week) at a moderate intensity, 6 educational nutritional intervention sessions, and 8 sessions on energy and fatigue management. Receives: Other: Strength training, nutrition, and behavioral training |
| Self-Guided and Unsupervised Program with General Recommendations (PE1) | Active comparator | Participants will be involved in an unsupervised, self-directed program focusing on physical exercise (three times per week), nutrition and cognitive-behavioral habits. Receives: Other: Self-Guided and Unsupervised Program with General Recommendations |
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 measured using an eight-item, 5-point Likert scale
Measured: Baseline (pre-intervention)
Satisfaction with Physical Activity
Satisfaction with Physical Activity will be measured using an eight-item, 5-point Likert scale
Measured: Immediately after the intervention
Visual Analogue Scale for Fatigue (VAS-F)
The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective levels of fatigue and energy
Measured: Immediately before each of the 36 exercise sessions (pre-session assessment).
Visual Analogue Scale for Fatigue (VAS-F)
The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective levels of fatigue and energy
Measured: Immediately after each of the 36 exercise sessions (post-session assessment).
Modified Fatigue Impact Scale (MFIS)
Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84).
Measured: Baseline (pre-intervention).
Modified Fatigue Impact Scale (MFIS)
Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84)
Measured: 48 hours after the last exercise session (post-intervention assessment).
Secondary outcomes (61)
Inflammatory Profile
The inflammatory profile evaluates key cytokines, including IFN-γ, IL-6, TNF-α, IL-10, and TGF-β1, to assess systemic inflammation and immune response dynamics
Measured: Baseline (pre-intervention).
Inflammatory Profile
The inflammatory profile evaluates key cytokines, including IFN-γ, IL-6, TNF-α, IL-10, and TGF-β1, to assess systemic inflammation and immune response dynamics
Measured: 48 hours after the last exercise session (post-intervention assessment).
The hormonal profile
The hormonal profile includes the assessment of TSH, progesterone (PG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol, and testosterone to evaluate endocrine function, menstrual cycle phases, and hormonal balance.
Measured: Pre-intervention in each phase of the menstrual cycle (early follicular phase, late follicular phase and mid-luteal phase).
Cognitive Function
Brain-Derived Neurotrophic Factor (BDNF) is a protein involved in neuroplasticity, cognitive function, and neuronal survival, serving as a blood biomarker for brain health and adaptability.
Measured: Baseline (pre-intervention).
Cognitive Function
Brain-Derived Neurotrophic Factor (BDNF) is a protein involved in neuroplasticity, cognitive function, and neuronal survival, serving as a blood biomarker for brain health and adaptability
Measured: 48 hours after the last exercise session (post-intervention assessment).
Neurofilament Light Chain (NFL)
Neurofilament light chain (NFL) is one of the most relevant biomarkers in multiple sclerosis (MS). The Simoa detection technique (ultrasensitive single-molecule array) allows its analysis in serum, providing both the total value and the Z-Score, enabling precise assessment of axonal damage and disease progression.
Measured: Baseline (pre-intervention).
Neurofilament Light Chain (NFL)
Neurofilament light chain (NFL) is one of the most relevant biomarkers in multiple sclerosis (MS). The Simoa detection technique (ultrasensitive single-molecule array) allows its analysis in serum, providing both the total value and the Z-Score, enabling precise assessment of axonal damage and disease progression.
Measured: 48 hours after the last exercise session (post-intervention assessment).
Physical Self-Perception
Physical self-perception will be evaluated using six subscales-sports competence, physical condition, body attractiveness, physical strength, general physical self-perception, and overall self-perception-on a 5-point Likert scale
Measured: Baseline (pre-intervention).
Physical Self-Perception
Physical self-perception will be evaluated using six subscales-sports competence, physical condition, body attractiveness, physical strength, general physical self-perception, and overall self-perception-on a 5-point Likert scale
Measured: 48 hours after the last exercise session (post-intervention assessment).
Walking Endurance
Participants will undergo the 2-minute walk test, during which they will walk at their preferred, self-selected speed to assess walking endurance. The test course will be rectangular, with corners marked by cones. Participants will be allowed to rest during the test, if necessary, but the clock will not stop during these rest periods. The total distance covered will be recorded
Measured: Baseline (pre-intervention).
Walking Endurance
Participants will undergo the 2-minute walk test, during which they will walk at their preferred, self-selected speed to assess walking endurance. The test course will be rectangular, with corners marked by cones. Participants will be allowed to rest during the test, if necessary, but the clock will not stop during these rest periods. The total distance covered will be recorded
Measured: 48 hours after the last exercise session (post-intervention assessment).
Pain Catastrophizing
The Pain Catastrophizing Scale will measure catastrophic thoughts related to pain, focusing on rumination and helplessness, with responses on a similar scale
Measured: Baseline (pre-intervention).
Pain Catastrophizing
The Pain Catastrophizing Scale will measure catastrophic thoughts related to pain, focusing on rumination and helplessness, with responses on a similar scale
Measured: 48 hours after the last exercise session (post-intervention assessment).
Quality of Life questionnaire
The Multiple Sclerosis Quality of Life-54 will gauge quality of life across 14 subscales, yielding physical and mental health composite scores
Measured: Baseline (pre-intervention).
Quality of Life questionnaire
The Multiple Sclerosis Quality of Life-54 will gauge quality of life across 14 subscales, yielding physical and mental health composite scores
Measured: 48 hours after the last exercise session (post-intervention assessment).
State-Trait Anxiety
Description: The State-Trait Anxiety Inventory will measure both situational and general anxiety on a 4-point scale
Measured: Baseline (pre-intervention).
State-Trait Anxiety
The State-Trait Anxiety Inventory will measure both situational and general anxiety on a 4-point scaleTime Frame: Before the first training session
Measured: 48 hours after the last exercise session (post-intervention assessment).
Rate of force development
Participants will sit in a chair with both legs flexed at a 90-degree angle, and the tested ankle securely attached to a customized device with a load cell (MuscleLab Force Sensor, Ergotest AS, Langesund, Norway). They will perform three maximum contractions, each lasting 2 seconds, with 3 minutes of rest in between. The RFD will be analyzed. Testing will begin with the right leg, and the repetition with the highest recorded value for each leg will be used in the analysis
Measured: Baseline (pre-intervention).
Rate of force development
Participants will sit in a chair with both legs flexed at a 90-degree angle, and the tested ankle securely attached to a customized device with a load cell (MuscleLab Force Sensor, Ergotest AS, Langesund, Norway). They will perform three maximum contractions, each lasting 2 seconds, with 3 minutes of rest in between. The RFD will be analyzed. Testing will begin with the right leg, and the repetition with the highest recorded value for each leg will be used in the analysis
Measured: 48 hours after the last exercise session (post-intervention assessment).
Maximum Voluntary Isometric Contraction
Participants will sit in a chair with both legs flexed at a 90-degree angle, and the tested ankle securely attached to a customized device with a load cell (MuscleLab Force Sensor, Ergotest AS, Langesund, Norway).Participants will perform three 5-second MVIC, with 3 minutes of rest in between. Testing will always begin with the right leg, and the contraction with the highest recorded MVIC value will be used in the analysis Time Frame: Before the first training session
Measured: Baseline (pre-intervention).
Maximum Voluntary Isometric Contraction
Participants will sit in a chair with both legs flexed at a 90-degree angle, and the tested ankle securely attached to a customized device with a load cell (MuscleLab Force Sensor, Ergotest AS, Langesund, Norway).Participants will perform three 5-second MVIC, with 3 minutes of rest in between. Testing will always begin with the right leg, and the contraction with the highest recorded MVIC value will be used in the analysis Time Frame: Before the first training session
Measured: 48 hours after the last exercise session (post-intervention assessment).
Maximal neural drive
To measure neural drive, the electromyographic activity (sEMG) of the right leg's vastus lateralis will be recorded during the MVIC (Delsys Trigno, Delsys Inc., Boston, MA) with skin prepared and electrode positioning following SENIAM guidelines. EMG peak will be analyzed. The EMG peak during MVIC will represent the maximum neural drive
Measured: Baseline (pre-intervention).
Maximal neural drive
To measure neural drive, the electromyographic activity (sEMG) of the right leg's vastus lateralis will be recorded during the MVIC (Delsys Trigno, Delsys Inc., Boston, MA) with skin prepared and electrode positioning following SENIAM guidelines. EMG peak will be analyzed. The EMG peak during MVIC will represent the maximum neural drive
Measured: 48 hours after the last exercise session (post-intervention assessment).
Central activation ratio
Two bipolar electrodes (10×15 cm) will be placed on the right quadriceps, with electrical stimulation controlled by Signal 6.0 software (CED, Cambridge, England) at 100 Hz frequency, 50 pulses, 0.009 s pulse duration, and 0.01 s interval, set to 40-50% of MVIC. Central activation ratio (CAR) will be assessed through a sequence of one supramaximal twitch, a 100 Hz tetanic train, an MVIC with superimposed tetanic train, followed by a potentiated tetanic train and a potentiated supramaximal twitch. This sequence will be repeated twice with 2-minute rests, and twitch-to-tetanus ratio, MVIC peak, and maximum force values will be calculated for CAR. The CAR will be calculated using the following formula: "CAR= " "Force during MVIC" /"Force during MVIC + supramaximal stimulation"
Measured: Baseline (pre-intervention).
Central activation ratio
Two bipolar electrodes (10×15 cm) will be placed on the right quadriceps, with electrical stimulation controlled by Signal 6.0 software (CED, Cambridge, England) at 100 Hz frequency, 50 pulses, 0.009 s pulse duration, and 0.01 s interval, set to 40-50% of MVIC. Central activation ratio (CAR) will be assessed through a sequence of one supramaximal twitch, a 100 Hz tetanic train, an MVIC with superimposed tetanic train, followed by a potentiated tetanic train and a potentiated supramaximal twitch. This sequence will be repeated twice with 2-minute rests, and twitch-to-tetanus ratio, MVIC peak, and maximum force values will be calculated for CAR. The CAR will be calculated using the following formula: "CAR= " "Force during MVIC" /"Force during MVIC + supramaximal stimulation"
Measured: 48 hours after the last exercise session (post-intervention assessment).
Upper Limb Maximum Strength
Isometric grip strength will be measured with an electronic dynamometer (K-Force Grip, Kinvent, Montpellier, France) as participants stand with elbows extended. Each hand will perform 3 trials, with 30 seconds rest between attempts
Measured: Baseline (pre-intervention).
Upper Limb Maximum Strength
Isometric grip strength will be measured with an electronic dynamometer (K-Force Grip, Kinvent, Montpellier, France) as participants stand with elbows extended. Each hand will perform 3 trials, with 30 seconds rest between attempts
Measured: 48 hours after the last exercise session (post-intervention assessment).
Spasticity
The Pendulum Test is used to assess the level of spasticity by evaluating the resistance to passive movement in the affected limb. The test involves moving the limb in a pendulum-like motion and observing the fluidity of the movement, with increased resistance indicating higher spasticity levels
Measured: Before the first session of the intervention program
Spasticity
The Pendulum Test is used to assess the level of spasticity by evaluating the resistance to passive movement in the affected limb. The test involves moving the limb in a pendulum-like motion and observing the fluidity of the movement, with increased resistance indicating higher spasticity levels
Measured: 48 hours after the last exercise session (post-intervention assessment).
Intrinsic muscle characteristics
Muscle characteristics (frequency, stiffness, degradation) assessed with MyotonPRO (MyotonPRO, Myoton AS, Estonia)
Measured: Baseline (pre-intervention).
Intrinsic muscle characteristics
Muscle characteristics (frequency, stiffness, degradation) assessed with MyotonPRO (MyotonPRO, Myoton AS, Estonia)
Measured: 48 hours after the last exercise session (post-intervention assessment).
Gait speed
Gait speed will be determined with the 10-meter walk test using two photocells (Ergotest Technology AS, Langesund, Norway) at 5 and 10 meters; participants will complete two maximum-speed trials, with the slower time recorded
Measured: Baseline (pre-intervention).
Gait speed
Gait speed will be determined with the 10-meter walk test using two photocells (Ergotest Technology AS, Langesund, Norway) at 5 and 10 meters; participants will complete two maximum-speed trials, with the slower time recorded
Measured: 48 hours after the last exercise session (post-intervention assessment).
Static balance with eyes open
Balance is measured with static trials on a force platform (Ergotest Technology AS, Langesund, Norway), where participants stand barefoot with arms at their sides for two 30-second trials each
Measured: Baseline (pre-intervention).
Static balance with eyes open
Balance is measured with static trials on a force platform (Ergotest Technology AS, Langesund, Norway), where participants stand barefoot with arms at their sides for two 30-second trials each
Measured: 48 hours after the last exercise session (post-intervention assessment).
Static balance with eyes closed
Balance is measured with static trials on a force platform (Ergotest Technology AS, Langesund, Norway), where participants stand barefoot with arms at their sides for two 30-second trials each
Measured: Baseline (pre-intervention).
Static balance with eyes closed
Balance is measured with static trials on a force platform (Ergotest Technology AS, Langesund, Norway), where participants stand barefoot with arms at their sides for two 30-second trials each
Measured: 48 hours after the last exercise session (post-intervention assessment).
Sit-to-stand
The sit-to-stand test requires participants to rise as quickly as possible from a seated position with 90º knee flexion and arms crossed
Measured: Baseline (pre-intervention).
Sit-to-stand
The sit-to-stand test requires participants to rise as quickly as possible from a seated position with 90º knee flexion and arms crossed
Measured: 48 hours after the last exercise session (post-intervention assessment).
Timed Up-and-Go test
In the Timed Up-and-Go test, participants move from sitting to standing, walk 3 meters, turn, return, and sit
Measured: Baseline (pre-intervention).
Timed Up-and-Go test
In the Timed Up-and-Go test, participants move from sitting to standing, walk 3 meters, turn, return, and sit
Measured: 48 hours after the last exercise session (post-intervention assessment).
Delayed onset muscle soreness
To measure delayed onset muscle soreness (DOMS), a 10-point visual analogue scale shall be used, where 1 = no pain and 10 = intolerable pain
Measured: Baseline (pre-intervention).
Subjective Perception of Effort
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 exercise within the session), and after the training session using the Borg 6-20 RPE scale
Measured: Baseline (pre-intervention).
Fatigue Visual Analog Scale (VAS-F)
The VAS-F will be used to measure fatigue. This scale, is subdivided into two subscales: fatigue and energy. The VAS-F features a 100 mm long horizontal line, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line corresponding to their perception of the severity of fatigue between these two endpoints.
Measured: Baseline (pre-intervention).
Anthropometric
Anthropometric measurements will be taken to assess body morphology, fat distribution, and potential alterations due to multiple sclerosis (MS), such as muscle atrophy or changes in body fat percentage. These measurements provide valuable information regarding comorbidities, including abdominal obesity and cardiovascular risk, which are particularly relevant in MS due to factors like reduced mobility or medication use
Measured: Baseline (pre-intervention).
Anthropometric
Anthropometric measurements will be taken to assess body morphology, fat distribution, and potential alterations due to multiple sclerosis (MS), such as muscle atrophy or changes in body fat percentage. These measurements provide valuable information regarding comorbidities, including abdominal obesity and cardiovascular risk, which are particularly relevant in MS due to factors like reduced mobility or medication use
Measured: 48 hours after the last exercise session (post-intervention assessment).
Bioimpedance
Bioimpedance will be used to assess body composition, including body fat percentage, lean mass, and total body water. These measurements are important for understanding changes in body composition due to multiple sclerosis (MS), as the disease can impact muscle mass, fluid balance, and fat distribution. Bioimpedance provides valuable insight into the health status and nutritional needs of individuals with MS
Measured: Baseline (pre-intervention).
Bioimpedance
Bioimpedance will be used to assess body composition, including body fat percentage, lean mass, and total body water. These measurements are important for understanding changes in body composition due to multiple sclerosis (MS), as the disease can impact muscle mass, fluid balance, and fat distribution. Bioimpedance provides valuable insight into the health status and nutritional needs of individuals with MS
Measured: 48 hours after the last exercise session (post-intervention assessment).
Physical Activity Levels
To assess physical activity in patients with multiple sclerosis (MS), both the International Physical Activity Questionnaire (IPAQ) and triaxial accelerometers can be adapted to account for the mobility limitations often experienced by these individuals. The IPAQ can be tailored by including questions that specifically address low-impact or moderate-intensity activities, considering factors such as fatigue and muscle weakness. Triaxial accelerometers, which measure movement in three planes (vertical, lateral, and anterior-posterior), provide a more detailed and precise measurement of physical activity, capturing even small movements or low-intensity activities such as walking short distances. Together, these tools allow for a comprehensive assessment of physical activity levels in MS patients, while considering their unique needs and capabilities. Additionally, the MET (Metabolic Equivalent of Task) methodology should be adjusted to reflect the lower intensity of activities commonly p
Measured: Baseline (pre-intervention).
Physical Activity Levels
To assess physical activity in patients with multiple sclerosis (MS), both the International Physical Activity Questionnaire (IPAQ) and triaxial accelerometers can be adapted to account for the mobility limitations often experienced by these individuals. The IPAQ can be tailored by including questions that specifically address low-impact or moderate-intensity activities, considering factors such as fatigue and muscle weakness. Triaxial accelerometers, which measure movement in three planes (vertical, lateral, and anterior-posterior), provide a more detailed and precise measurement of physical activity, capturing even small movements or low-intensity activities such as walking short distances. Together, these tools allow for a comprehensive assessment of physical activity levels in MS patients, while considering their unique needs and capabilities. Additionally, the MET (Metabolic Equivalent of Task) methodology should be adjusted to reflect the lower intensity of activities commonly p
Measured: 48 hours after the last exercise session (post-intervention assessment).
Dietary and Nutritional Follow-up
Mediterranean Diet adherence questionnaires and food diaries could be effective tools for evaluating nutrition, particularly if MS patients have poor consumption of essential nutrients for their overall health
Measured: Baseline (pre-intervention).
Dietary and Nutritional Follow-up
Mediterranean Diet adherence questionnaires and food diaries could be effective tools for evaluating nutrition, particularly if MS patients have poor consumption of essential nutrients for their overall health
Measured: 48 hours after the last exercise session (post-intervention assessment).
The Kurtzke Disability Scale
The Kurtzke Disability Scale (EDSS) is divided into 8 functional systems (FS); four primary: pyramidal function, cerebellar function, sensory function, and brainstem function; and four secondary: sphincters, vision, mental, and others. For each FS, a severity score is provided, ranging from 0 to 6 or 7. The overall score of the scale is measured on a 20-item scale (from 0 to 10 points, increasing in half-point increments). Up to 3.5, the score obtained in each FS and the number of affected FS automatically determine the EDSS score. From 4 to 7, the definition of each level is also given by the ability to walk (ability to walk without stopping, need for assistance)
Measured: Baseline (pre-intervention).
The Kurtzke Disability Scale
The Kurtzke Disability Scale (EDSS) is divided into 8 functional systems (FS); four primary: pyramidal function, cerebellar function, sensory function, and brainstem function; and four secondary: sphincters, vision, mental, and others. For each FS, a severity score is provided, ranging from 0 to 6 or 7. The overall score of the scale is measured on a 20-item scale (from 0 to 10 points, increasing in half-point increments). Up to 3.5, the score obtained in each FS and the number of affected FS automatically determine the EDSS score. From 4 to 7, the definition of each level is also given by the ability to walk (ability to walk without stopping, need for assistance).
Measured: 48 hours after the last exercise session (post-intervention assessment).
Subjective Sleep Quality Questionnaire
Subjective sleep quality will be measured using the Karolinska Sleep Diary questionnaire [73]. 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 (woke up too early [1] - did not wake up early [3]), e) ease of waking up (very difficult [1] - very easy [5]), f) feeling of rest (did not rest at all [1] - fully rested [3]), and g) sufficient sleep (no, definitely too little [1] - yes, definitely enough [5]).
Measured: Baseline (pre-intervention).
Subjective Sleep Quality Questionnaire
Subjective sleep quality will be measured using the Karolinska Sleep Diary questionnaire [73]. 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 (woke up too early [1] - did not wake up early [3]), e) ease of waking up (very difficult [1] - very easy [5]), f) feeling of rest (did not rest at all [1] - fully rested [3]), and g) sufficient sleep (no, definitely too little [1] - yes, definitely enough [5]).
Measured: 48 hours after the last exercise session (post-intervention assessment).
Sleep Quality Measured by Actigraph
Sleep quality based on actigraphy will be evaluated using the Actiwatch wGT3X-BT activity monitoring system (Cambridge Neurotechnology, Cambridge, UK) [74]. This device uses a piezoelectric accelerometer to measure activity. Participants will wear the Actiwatch on their non-dominant wrist. The lower sensitivity threshold for actigraphy will be set at 80 counts/epoch. Data analysis will begin at the start of the nighttime rest period (bedtime) and conclude at the start of daytime activity (wake-up time).
Measured: The week prior to the start of the intervention. Baseline (pre-intervention).
Sleep Quality Measured by Actigraph
Sleep quality based on actigraphy will be evaluated using the Actiwatch wGT3X-BT activity monitoring system (Cambridge Neurotechnology, Cambridge, UK) [74]. This device uses a piezoelectric accelerometer to measure activity. Participants will wear the Actiwatch on their non-dominant wrist. The lower sensitivity threshold for actigraphy will be set at 80 counts/epoch. Data analysis will begin at the start of the nighttime rest period (bedtime) and conclude at the start of daytime activity (wake-up time)
Measured: The week following the completion of the intervention (post-intervention assessment).
Delayed onset muscle soreness
To measure delayed onset muscle soreness (DOMS), a 10-point visual analogue scale shall be used, where 1 = no pain and 10 = intolerable pain
Measured: Immediately after each physical exercise session (post-intervention assessment).
Subjective Perception of Effort
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 exercise within the session), and after the training session using the Borg 6-20 RPE scale
Measured: Immediately after each physical exercise session (post-intervention assessment).
Fatigue Visual Analog Scale (VAS-F)
The VAS-F will be used to measure fatigue. This scale, is subdivided into two subscales: fatigue and energy. The VAS-F features a 100 mm long horizontal line, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line corresponding to their perception of the severity of fatigue between these two endpoints.
Measured: Immediately after each physical exercise session (post-intervention assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Apr 2025
- Primary completion15 Jun 2025
- Study completion28 Jul 2026
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 Sclerosis (MS) - Relapsing-remittingStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Arrixaca
- Responsible party
- Principal investigator, Jacobo Á. Rubio-Arias, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884579
- Sponsor's protocol ID
- 2024-3-15-HCUVA
- Other IDs
- PID2021-123447OA-I00
- Acronym
- ADVICE Phase 2
- Status last verified
- Sep 2026
- First submitted
- 20 Feb 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rubio-Arias JA, Ramos-Campo DJ, Andreu-Caravaca L, Cupeiro R, Marin-Jimenez N, Romero-Parra N, Meca-Lallana JE, Martinez-Rodriguez A, Gonzalvez-Alvarado L, Munoz-Villena AJ, Lara-Sanchez AJ, Benitez-Munoz JA, Lopez-Liria R, Molina-Torres G, Iniesta-Martinez F, Valero Lopez G, Ferrer Contreras MDC, Lopez Roman J, Avila-Gandia V. Educational programs based on healthy habits to improve quality of life and psychosocial profile in women with multiple sclerosis: The ADVICE protocol study. Contemp Clin Trials. 2026 Sep;168:108406. doi: 10.1016/j.cct.2026.108406. Epub 2026 Jul 16.
PubMed 42462809
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study
- ClinicalTrials.gov ID
- NCT06884579
- Acronym / sponsor ID
- ADVICE Phase 2 / 2024-3-15-HCUVA
- Keywords
- Relapsing-Remitting MS, Fatigue, Cognitive Behavioral Therapy, Physical exercise, Dietary habits, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Arrixaca
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 19 Mar 2025 (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 phase of the project aims to compare in-person, supervised educational programs (EP) with online self-guided EPs in individuals with relapsing-remitting multiple sclerosis. A total of 75 participants will be randomly assigned to one of three groups: a supervised and individualized educational program focused on HIIT training, a supervised and individualized educational program focused on strength training, and a non-supervised, self-guided educational program based on resistance band training. Additionally, sessions on the Mediterranean diet (both supervised and non-supervised) and cognitive-behavioral interventions will be included. A control evaluation will be conducted three months after the intervention to assess the effects of the educational programs, followed by another evaluation three months later to analyze residual effects. Women who participated in Phase 1 of the study will be invited to take part in this second phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Strength Training Program (PE1) | Experimental | Other: Strength training, nutrition, and behavioral trainingParticipants will complete 36 strength sessions (3 times a week) at a moderate intensity, 6 educational nutritional intervention sessions, and 8 sessions on energy and fatigue management. |
| Self-Guided and Unsupervised Program with General Recommendations (PE1) | Active comparator | Other: Self-Guided and Unsupervised Program with General RecommendationsParticipants will be involved in an unsupervised, self-directed program focusing on physical exercise (three times per week), nutrition and cognitive-behavioral habits. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women and men of reproductive age (18-45 years) with MS will be included, with the upper age limit adjusted to reflect the reproductive phase;
- no iron-deficiency anemia;
- stable disease phase;
- independent walking ability for over 10 meters.
- Women will be recruited first and later matched with men based on age, EDSS, and lifestyle habits (physical activity, smoking, and alcohol consumption).
Key exclusion criteria (5 listed)
- score <1 or >6 on the EDSS;
- report a relapse within 12 months before the study begins;
- have taken corticosteroid treatment within the last 2 months;
- have participated in a structured training program in the previous 6 months.
- Once all women with MS are recruited, male participants will be recruited following a 1:1 matching methodology based on age, geographic region, and lifestyle habits.
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, nutrition, and behavioral trainingThis arm of the study consists of a supervised strength training program, conducted over 12 weeks with three weekly sessions. The sessions follow a wave-like periodization, with intensities ranging from 70% to 85% of 1-RM. Exercises focus on enhancing neuromuscular strength in the lower limbs, such as leg presses and hip extensions, under the supervision of a multidisciplinary team. Participants will also receive nutritional guidance based on the Mediterranean diet, as well as cognitive-behavioral therapy strategies aimed at optimizing fatigue management and boosting energy levels. | Other | Supervised Strength Training Program (PE1) |
| Self-Guided and Unsupervised Program with General RecommendationsThis arm of the study consists of a self-guided and unsupervised program based on physical exercise (3 times per week), nutrition, and cognitive-behavioral habits. Participants will access online modules that provide guidelines for performing resistance exercises with bands, dietary recommendations following the principles of the Mediterranean diet, and cognitive-behavioral techniques for fatigue management. | Other | Self-Guided and Unsupervised Program with General Recommendations (PE1) |
Primary outcome
Satisfaction with Physical Activity
Time frame: Baseline (pre-intervention)
Satisfaction with Physical Activity will be measured using an eight-item, 5-point Likert scale
Satisfaction with Physical Activity
Time frame: Immediately after the intervention
Satisfaction with Physical Activity will be measured using an eight-item, 5-point Likert scale
Visual Analogue Scale for Fatigue (VAS-F)
Time frame: Immediately before each of the 36 exercise sessions (pre-session assessment).
The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective levels of fatigue and energy
Visual Analogue Scale for Fatigue (VAS-F)
Time frame: Immediately after each of the 36 exercise sessions (post-session assessment).
The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective levels of fatigue and energy
Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline (pre-intervention).
Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84).
Modified Fatigue Impact Scale (MFIS)
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84)
61 secondary outcomes
Inflammatory Profile
Time frame: Baseline (pre-intervention).
Inflammatory Profile
Time frame: 48 hours after the last exercise session (post-intervention assessment).
The hormonal profile
Time frame: Pre-intervention in each phase of the menstrual cycle (early follicular phase, late follicular phase and mid-luteal phase).
Cognitive Function
Time frame: Baseline (pre-intervention).
Cognitive Function
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Neurofilament Light Chain (NFL)
Time frame: Baseline (pre-intervention).
Neurofilament Light Chain (NFL)
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Physical Self-Perception
Time frame: Baseline (pre-intervention).
Physical Self-Perception
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Walking Endurance
Time frame: Baseline (pre-intervention).
Walking Endurance
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Pain Catastrophizing
Time frame: Baseline (pre-intervention).
Pain Catastrophizing
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Quality of Life questionnaire
Time frame: Baseline (pre-intervention).
Quality of Life questionnaire
Time frame: 48 hours after the last exercise session (post-intervention assessment).
State-Trait Anxiety
Time frame: Baseline (pre-intervention).
State-Trait Anxiety
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Rate of force development
Time frame: Baseline (pre-intervention).
Rate of force development
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Maximum Voluntary Isometric Contraction
Time frame: Baseline (pre-intervention).
Maximum Voluntary Isometric Contraction
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Maximal neural drive
Time frame: Baseline (pre-intervention).
Maximal neural drive
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Central activation ratio
Time frame: Baseline (pre-intervention).
Central activation ratio
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Upper Limb Maximum Strength
Time frame: Baseline (pre-intervention).
Upper Limb Maximum Strength
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Spasticity
Time frame: Before the first session of the intervention program
Spasticity
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Intrinsic muscle characteristics
Time frame: Baseline (pre-intervention).
Intrinsic muscle characteristics
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Gait speed
Time frame: Baseline (pre-intervention).
Gait speed
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Static balance with eyes open
Time frame: Baseline (pre-intervention).
Static balance with eyes open
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Static balance with eyes closed
Time frame: Baseline (pre-intervention).
Static balance with eyes closed
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Sit-to-stand
Time frame: Baseline (pre-intervention).
Sit-to-stand
Time frame: 48 hours after the last exercise session (post-intervention assessment).
Timed Up-and-Go test
Time frame: Baseline (pre-intervention).
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 30 Sep 2026.
- Derived from this study: PubMed 42462809Rubio-Arias JA, Ramos-Campo DJ, Andreu-Caravaca L, Cupeiro R, Marin-Jimenez N, Romero-Parra N, Meca-Lallana JE, Martinez-Rodriguez A, Gonzalvez-Alvarado L, Munoz-Villena AJ, Lara-Sanchez AJ, Benitez-Munoz JA, Lopez-Liria R, Molina-Torres G, Iniesta-Martinez F, Valero Lopez G, Ferrer Contreras MDC, Lopez Roman J, Avila-Gandia V. Educational programs based on healthy habits to improve quality of life and psychosocial profile in women with multiple sclerosis: The ADVICE protocol study. Contemp Clin Trials. 2026 Sep;168:108406. doi: 10.1016/j.cct.2026.108406. Epub 2026 Jul 16.
- Individual participant dataSharing planned: Undecided
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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, nutrition, and behavioral training and Self-Guided and Unsupervised Program with General Recommendations in people with Multiple Sclerosis (MS) - Relapsing-remitting, 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 5 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 30 Sep 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: Baseline (pre-intervention)). The study lists 6 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 NCT06884579, 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 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.