FibromyalgiaFM PROTOCOLNCT06393790
Strength Training Protocol in Fibromyalgia Women
A study testing FMG (Fibromyalgia group) and HG (Healthy group) in people with Fibromyalgia and Fatigue, run by Catholic University of Murcia at 1 site in Spain.
Trial summary
Physical exercise is an effective tool for the prevention of various chronic diseases. Fibromyalgia (FM) is a common chronic pain condition, in which patients may also experience a variety of other symptoms, including sleep disturbances, fatigue, stiffness, frequent episodes of pain and mental health problems, as well… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Fatigue, Fatigue; Muscle, Heart
- What is being tested?
- FMG (Fibromyalgia group) and HG (Healthy group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 1 Jan 2025
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women previously diagnosed with fibromyalgia and healthy women aged 18-75 years.
- Not be undertaking any physical activity or exercise programme for at least three months prior to the start of the protocol.
Who cannot join
- Participants in the study may not present any other illness and/or injury at the time of the assessments that would prevent them from carrying out the activity. In the same way, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad Deporte Universidad Católica San Antonio de Murcia
Murcia, España, 30107
About this study
Official title: Health Effects of a Strength Training Protocol in Women With Fibromyalgia and Healthy Individuals.
Physical exercise is an effective tool for the prevention of various chronic diseases. Fibromyalgia (FM) is a common chronic pain condition, in which patients may also experience a variety of other symptoms, including sleep disturbances, fatigue, stiffness, frequent episodes of pain and mental health problems, as well as possible gastrointestinal disorders. Furthermore, according to the American College of Rheumatology, such a generalised non-joint pain state occurs for at least three months in duration, predominantly in women over 50 years of age. In turn, chronic fatigue syndrome (CFS) presents as a disease characterised by persistent and debilitating fatigue lasting at least six months.
The origin of FM and CFS is unknown, although alterations in the central nervous system (CNS), as well as abnormalities in muscle physiology and immune/inflammatory response are suggested as the main causes.
Read more
In addition, most patients with FM are sedentary and in poor physical condition, exacerbated by pain, fatigue or depression, which can limit their daily activities and affect their quality of life and work opportunities. In this regard, physical exercise is considered the most important non-pharmacological strategy for the treatment of FM; however, many clinically relevant questions remain unanswered regarding the most effective approach to exercise therapy in FM patients.
Therefore, the main objective of this project is to analyse the possible physical and mental benefits of a physical exercise programme in people diagnosed with fibromyalgia and/or chronic fatigue syndrome.
- Conditions
- Fibromyalgia, Fatigue, Fatigue; Muscle, Heart, Strength Training, Stress
- Being tested
- FMG (Fibromyalgia group), HG (Healthy group)
- Keywords
- Anxiety, exercise, Strength training, fibromyalgia, healthy individuals, women, neuroinmunoendocrine system
- Medical subject headings
- Fibromyalgia, Fatigue, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMG (Fibromyalgia group)Behavioural
This intervention will report results of a strength training programme in people with fibromyalgia
HG (Healthy group)Behavioural
This intervention will report results of a strength training programme in people with no fibromyalgia diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Strength training group with fibromyalgia diagnosis | Experimental | The sample will be composed of 15 subjects (women), aged between 18 and 70 years. Participants must have been diagnosed with fibromyalgia (FM) and/or chronic fatigue syndrome (CFS) at least three months before the start of the study.
Study participants must not have any other illness and/or injury at the time of the assessments that would prevent them from performing the activity. Likewise, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research. Receives: Behavioral: FMG (Fibromyalgia group) |
| Strength training group in no fibromyalgia women | Active comparator | The sample will be composed of 15 subjects (women), aged between 45 and 70 years. Participants must have not been diagnosed with fibromyalgia. These participants must be healthy individuals.
Study participants must not have any other illness and/or injury at the time of the assessments that would prevent them from performing the activity. Likewise, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research. Receives: Behavioral: HG (Healthy group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRE-TEST Time up and go test (TUG test)
The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis
Measured: 7 days before protocol starts
PRE-TEST 5 Times Sit to stand test (5TSTS)
The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.
Measured: 7 days before protocol starts
PRE TEST 10 meters walk test
Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis
Measured: 7 days before protocol starts
PRE TEST 2 minutes walk
Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.
Measured: 7 days before protocol starts
PRE TEST Upper body dinamometry
The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.
Measured: 7 days before protocol starts
PRE TEST Lower body dinamometry
Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply "as much force as possible, as fast as possible" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.
Measured: 7 days before protocol starts
PRE TEST Sleep assessment: Karolinska Sleepiness Diary
The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.
Measured: 7 days before protocol starts
PRE TEST Beck Depression Inventory
Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.
Measured: 7 days before protocol starts
PRE TEST State-Trait Anxiety Inventory
State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.
Measured: 7 days before protocol starts
PRE TEST Perceived stress scale
The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.
Measured: 7 days before protocol starts
PRE TEST Pain and fatigue Inventory
-Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).
Measured: 7 days before protocol starts
PRE TEST Pittsburgh Sleep Quality Questionnaire (PSQI)
Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.
Measured: 7 days before protocol starts
PRE TEST FIQ (Fibromyalgia Impact Questionnaire)
FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.
Measured: 7 days before protocol starts
PRE TEST Ergospirometry
The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.
Measured: 7 days before protocol starts
PRE TEST Heart Rate Variability (HRV)
HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.
Measured: 7 days before protocol starts
PRE TEST BLOOD EXTRACTION
To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.
Measured: 7 days before protocol starts
PRE TEST Balance test
Determination of monopodal and bipodal equilibrium levels.
Measured: 7 days before protocol starts
POST-TEST Time up and go test (TUG test)
The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis
Measured: 7 days after protocol ends
POST-TEST 5 Times Sit to stand test (5TSTS)
The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.
Measured: 7 days after protocol ends
POST TEST 10 meters walk test
Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis
Measured: 7 days after protocol ends
POST TEST 2 minutes walk
Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.
Measured: 7 days after protocol ends
POST TEST Upper body dinamometry
The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.
Measured: 7 days after protocol ends
POST TEST Lower body dinamometry
Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply "as much force as possible, as fast as possible" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.
Measured: 7 days after protocol ends
POST TEST Sleep assessment: Karolinska Sleepiness Diary
The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.
Measured: 7 days after protocol ends
POST TEST Beck Depression Inventory
Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.
Measured: 7 days after protocol ends
POST TEST State-Trait Anxiety Inventory
State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.
Measured: 7 days after protocol ends
POST TEST Perceived stress scale
The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.
Measured: 7 days after protocol ends
POST TEST Pain and fatigue Inventory
-Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).
Measured: 7 days after protocol ends
POST TEST Pittsburgh Sleep Quality Questionnaire (PSQI)
Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.
Measured: 7 days after protocol ends
POST TEST FIQ (Fibromyalgia Impact Questionnaire)
FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.
Measured: 7 days after protocol ends
POST TEST Ergospirometry
The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.
Measured: 7 days after protocol ends
POST TEST Heart Rate Variability (HRV)
HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.
Measured: 7 days after protocol ends
POST TEST BLOOD EXTRACTION
To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.
Measured: 7 days after protocol ends
POST TEST Balance test
Determination of monopodal and bipodal equilibrium levels.
Measured: 7 days after protocol ends
Secondary outcomes (12)
ACUTE PRE-TEST Time up and go test (TUG test)
The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis
Measured: 5 week since the start of the protocol
ACUTE POST-TEST Time up and go test (TUG test)
The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis
Measured: 5 week since the start of the protocol
ACUTE PRE-TEST 5 Times Sit to stand test (5TSTS)
The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.
Measured: 5 week since the start of the protocol
ACUTE POST-TEST 5 Times Sit to stand test (5TSTS)
The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.
Measured: 5 week since the start of the protocol
ACUTE PRE TEST 10 meters walk test
Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis
Measured: 5 week since the start of the protocol
ACUTE POST TEST 10 meters walk test
Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis
Measured: 5 week since the start of the protocol
ACUTE PRE TEST Upper body dinamometry
The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.
Measured: 5 week since the start of the protocol
ACUTE POST TEST Upper body dinamometry
The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.
Measured: 5 week since the start of the protocol
ACUTE PRE TEST Lower body dinamometry
Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply "as much force as possible, as fast as possible" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.
Measured: 5 week since the start of the protocol
ACUTE POST TEST Lower body dinamometry
Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply "as much force as possible, as fast as possible" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.
Measured: 5 week since the start of the protocol
ACUTE PRE TEST Sleep assessment: Karolinska Sleepiness Diary
The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.
Measured: 5 week since the start of the protocol
ACUTE POST TEST Sleep assessment: Karolinska Sleepiness Diary
The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.
Measured: 5 week since the start of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Apr 2024
- Primary completion30 Jul 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Extremadura
- Responsible party
- Principal investigator, Carmen Daniela Quero Calero, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393790
- Sponsor's protocol ID
- TC/03-23
- Other IDs
- TC/03-23
- Acronym
- FM PROTOCOL
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be available upon request via email to the principal investigator, in this case Carmen Daniela Quero (cdquero@ucam.edu).
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of a Strength Training Protocol in Women With Fibromyalgia and Healthy Individuals.
- ClinicalTrials.gov ID
- NCT06393790
- Acronym / sponsor ID
- FM PROTOCOL / TC/03-23
- Conditions
- Fibromyalgia, Fatigue, Fatigue; Muscle, Heart, Strength Training, Stress
- Keywords
- Anxiety, exercise, Strength training, fibromyalgia, healthy individuals, women, neuroinmunoendocrine system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Catholic University of MurciaUniversity, hospital or other
- Collaborators
- Universidad de Extremadura
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 1 May 2024 (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.
Physical exercise is an effective tool for the prevention of various chronic diseases. Fibromyalgia (FM) is a common chronic pain condition, in which patients may also experience a variety of other symptoms, including sleep disturbances, fatigue, stiffness, frequent episodes of pain and mental health problems, as well as possible gastrointestinal disorders. Furthermore, according to the American College of Rheumatology, such a generalised non-joint pain state occurs for at least three months in duration, predominantly in women over 50 years of age. In turn, chronic fatigue syndrome (CFS) presents as a disease characterised by persistent and debilitating fatigue lasting at least six months.
The origin of FM and CFS is unknown, although alterations in the central nervous system (CNS), as well as abnormalities in muscle physiology and immune/inflammatory response are suggested as the main causes.
In addition, most patients with FM are sedentary and in poor physical condition, exacerbated by pain, fatigue or depression, which can limit their daily activities and affect their quality of life and work opportunities. In this regard, physical exercise is considered the most important non-pharmacological strategy for the treatment of FM; however, many clinically relevant questions remain unanswered regarding the most effective approach to exercise therapy in FM patients.
Therefore, the main objective of this project is to analyse the possible physical and mental benefits of a physical exercise programme in people diagnosed with fibromyalgia and/or chronic fatigue syndrome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training group with fibromyalgia diagnosis | Experimental | Behavioral: FMG (Fibromyalgia group)The sample will be composed of 15 subjects (women), aged between 18 and 70 years. Participants must have been diagnosed with fibromyalgia (FM) and/or chronic fatigue syndrome (CFS) at least three months before the start of the study. Study participants must not have any other illness and/or injury at the time of the assessments that would prevent them from performing the activity. Likewise, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research. |
| Strength training group in no fibromyalgia women | Active comparator | Behavioral: HG (Healthy group)The sample will be composed of 15 subjects (women), aged between 45 and 70 years. Participants must have not been diagnosed with fibromyalgia. These participants must be healthy individuals. Study participants must not have any other illness and/or injury at the time of the assessments that would prevent them from performing the activity. Likewise, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women previously diagnosed with fibromyalgia and healthy women aged 18-75 years.
- Not be undertaking any physical activity or exercise programme for at least three months prior to the start of the protocol.
Key exclusion criteria (1 listed)
- Participants in the study may not present any other illness and/or injury at the time of the assessments that would prevent them from carrying out the activity. In the same way, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research.
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 |
|---|---|---|
| FMG (Fibromyalgia group)This intervention will report results of a strength training programme in people with fibromyalgia | Behavioural | Strength training group with fibromyalgia diagnosis |
| HG (Healthy group)This intervention will report results of a strength training programme in people with no fibromyalgia diagnosis | Behavioural | Strength training group in no fibromyalgia women |
Primary outcome
PRE-TEST Time up and go test (TUG test)
Time frame: 7 days before protocol starts
The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis
PRE-TEST 5 Times Sit to stand test (5TSTS)
Time frame: 7 days before protocol starts
The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.
PRE TEST 10 meters walk test
Time frame: 7 days before protocol starts
Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis
PRE TEST 2 minutes walk
Time frame: 7 days before protocol starts
Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.
PRE TEST Upper body dinamometry
Time frame: 7 days before protocol starts
The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.
PRE TEST Lower body dinamometry
Time frame: 7 days before protocol starts
Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply "as much force as possible, as fast as possible" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.
PRE TEST Sleep assessment: Karolinska Sleepiness Diary
Time frame: 7 days before protocol starts
The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.
PRE TEST Beck Depression Inventory
Time frame: 7 days before protocol starts
Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.
PRE TEST State-Trait Anxiety Inventory
Time frame: 7 days before protocol starts
State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.
PRE TEST Perceived stress scale
Time frame: 7 days before protocol starts
The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.
PRE TEST Pain and fatigue Inventory
Time frame: 7 days before protocol starts
-Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).
PRE TEST Pittsburgh Sleep Quality Questionnaire (PSQI)
Time frame: 7 days before protocol starts
Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.
PRE TEST FIQ (Fibromyalgia Impact Questionnaire)
Time frame: 7 days before protocol starts
FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.
PRE TEST Ergospirometry
Time frame: 7 days before protocol starts
The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.
PRE TEST Heart Rate Variability (HRV)
Time frame: 7 days before protocol starts
HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.
PRE TEST BLOOD EXTRACTION
Time frame: 7 days before protocol starts
To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.
PRE TEST Balance test
Time frame: 7 days before protocol starts
Determination of monopodal and bipodal equilibrium levels.
POST-TEST Time up and go test (TUG test)
Time frame: 7 days after protocol ends
The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis
POST-TEST 5 Times Sit to stand test (5TSTS)
Time frame: 7 days after protocol ends
The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.
POST TEST 10 meters walk test
Time frame: 7 days after protocol ends
Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis
POST TEST 2 minutes walk
Time frame: 7 days after protocol ends
Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.
POST TEST Upper body dinamometry
Time frame: 7 days after protocol ends
The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.
POST TEST Lower body dinamometry
Time frame: 7 days after protocol ends
Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply "as much force as possible, as fast as possible" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.
POST TEST Sleep assessment: Karolinska Sleepiness Diary
Time frame: 7 days after protocol ends
The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.
POST TEST Beck Depression Inventory
Time frame: 7 days after protocol ends
Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.
POST TEST State-Trait Anxiety Inventory
Time frame: 7 days after protocol ends
State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.
POST TEST Perceived stress scale
Time frame: 7 days after protocol ends
The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.
POST TEST Pain and fatigue Inventory
Time frame: 7 days after protocol ends
-Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).
POST TEST Pittsburgh Sleep Quality Questionnaire (PSQI)
Time frame: 7 days after protocol ends
Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.
POST TEST FIQ (Fibromyalgia Impact Questionnaire)
Time frame: 7 days after protocol ends
FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.
POST TEST Ergospirometry
Time frame: 7 days after protocol ends
The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.
POST TEST Heart Rate Variability (HRV)
Time frame: 7 days after protocol ends
HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.
POST TEST BLOOD EXTRACTION
Time frame: 7 days after protocol ends
To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.
POST TEST Balance test
Time frame: 7 days after protocol ends
Determination of monopodal and bipodal equilibrium levels.
12 secondary outcomes
ACUTE PRE-TEST Time up and go test (TUG test)
Time frame: 5 week since the start of the protocol
ACUTE POST-TEST Time up and go test (TUG test)
Time frame: 5 week since the start of the protocol
ACUTE PRE-TEST 5 Times Sit to stand test (5TSTS)
Time frame: 5 week since the start of the protocol
ACUTE POST-TEST 5 Times Sit to stand test (5TSTS)
Time frame: 5 week since the start of the protocol
ACUTE PRE TEST 10 meters walk test
Time frame: 5 week since the start of the protocol
ACUTE POST TEST 10 meters walk test
Time frame: 5 week since the start of the protocol
ACUTE PRE TEST Upper body dinamometry
Time frame: 5 week since the start of the protocol
ACUTE POST TEST Upper body dinamometry
Time frame: 5 week since the start of the protocol
ACUTE PRE TEST Lower body dinamometry
Time frame: 5 week since the start of the protocol
ACUTE POST TEST Lower body dinamometry
Time frame: 5 week since the start of the protocol
ACUTE PRE TEST Sleep assessment: Karolinska Sleepiness Diary
Time frame: 5 week since the start of the protocol
ACUTE POST TEST Sleep assessment: Karolinska Sleepiness Diary
Time frame: 5 week since the start of the protocol
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 13 Feb 2025.
- Individual participant dataSharing planned: Undecided. The data will be available upon request via email to the principal investigator, in this case Carmen Daniela Quero (cdquero@ucam.edu).
Related trials for Fibromyalgia
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Active, not recruiting
PEACE: Comparing Chronic Pain Treatment Options
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
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 FMG (Fibromyalgia group) and HG (Healthy group) in people with Fibromyalgia and Fatigue, run by Catholic University of Murcia 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 2 inclusion and 1 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 13 Feb 2025. 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?
PRE-TEST Time up and go test (TUG test) (time frame: 7 days before protocol starts). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2025; AzTrials last refreshed its copy on 2 Nov 2026.