Fibromyalgia (FM)FibrodExNCT07483216
Effects of a Isokinetic Exercise in Women With Fibromyalgia
A study testing Exercise in people with Fibromyalgia (FM), run by European University Miguel de Cervantes at 1 site in Spain.
Trial summary
Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional impairment, which significantly affects quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥ 18 years diagnosed with fibromyalgia according to current clinical criteria.
- Clinical and pharmacological stability during the weeks prior to participation in the study.
- Ability to perform supervised exercise and to complete the assessments.
- Written informed consent.
Who cannot join
- Cardiovascular, neurologic, musculoskeletal or systemic pathology that contraindicate the performance of exercise.
- Significant change in pharmacological treatment during the period immediately preceding the study.
- Any condition that, in clinical judgement, prevents them from following the protocol safely.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Miguel de Cervantes European University
Valladolid, Valladolid, 47012
Francisco Javier Gutiérrez Pecharromán, PhD, 0034983001000 ext. 22293, fjgutierrez@uemc.es
Alejandro Santos Lozano, PhD, 0034983001000 ext. 22292, asantos@uemc.es
About this study
Official title: Effects of a Microdoses Isokinetic Exercise Protocol in Women With Fibromyalgia
Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional impairment, which significantly affects quality of life. Physical exercise is considered one of the most effective non-pharmacological interventions for the management of this condition; however, uncertainty remains regarding the most appropriate type, intensity, and frequency of exercise for different patient profiles. The aim of this study is to analyze the effects of a microdoses isokinetic exercise program on physical condition, perceived pain, inflammatory profile and quality of life in women diagnosed with fibromyalgia.
Read the detailed description
Physical exercise is one of the non-pharmacological treatments with the strongest evidence and effectiveness in the management of fibromyalgia, as it has been shown to improve muscle strength and, consequently, patients' quality of life. One of the main limitations in this population is low adherence to traditional exercise programs due to chronic pain. Microdoses exercise training emerges as an alternative approach, based on the principle of the minimum effective dose. To implement this intervention, the training program will be conducted using isokinetic exercise, which allows precise control of movement velocity and joint position to ensure safe conditions. Accordingly, the aim of the present study is to evaluate the effects of an isokinetic exercise microdosing program in women with fibromyalgia over an 8-week intervention period.
- Conditions
- Fibromyalgia (FM)
- Being tested
- Exercise
- Keywords
- Fibromyalgia, Exercise, Isokinetic, Microdosing, Pain, Non-Pharmacological treatment
- Medical subject headings
- Fibromyalgia, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants assigned to the experimental group will perform the sessions under supervision. Each session will begin with a warm-up consisting of joint mobility exercises and 5 minutes of low-intensity cycling. This will be followed by the main exercise component, which will consist of one set of five repetitions of knee extension exercise. During the initial sessions, the exercise will be performed at 60°/s, with a gradual and controlled progression up to a maximum of eight repetitions. To finish, participants will complete 5 minutes of stretching and controlled breathing.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | An isokinetic exercise program of microdosing will be conducted over 8 weeks, with a frequency of three sessions per week, each lasting 20-25 minutes. Participants will also receive information on healthy lifestyle habits. Receives: Other: Exercise |
| Control group | No intervention | Participants assigned to the control group will continue with their usual treatment and will receive general recommendations for healthy lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak torque
The change in the peak torque (in Nm) will be assessed in the concentric part of a knee extension exercise (1x5) at 60º/s using the Biodex System 4.
Measured: Baseline, up to study completion (8 weeks); week 9
Peak torque
The change in the peak torque (in Nm) will be assessed in the eccentric part of a knee extension exercise (1x5) at 60º/s using the Biodex System 4.
Measured: Baseline, up to study completion (8 weeks); week 9
Agonist-antagonist ratio
The change in the agonist-antagonist ratio (%) of the knee extension exercise will be assessed using the Biodex System 4.
Measured: Baseline, up to study completion (8 weeks); week 9
Total work
The change in the total work (in J) of the knee extension exercise will be assessed using the Biodex System 4.
Measured: Baseline, up to study completion (8 weeks); week 9.
Height
The change in the height will be assessed by centimeters (cm).
Measured: Baseline, week 9
Secondary outcomes (29)
Muscle electrical activity (amplitude)
The MuscleLab system with electromyography will be used to measure muscle electrical activity in vastus lateralis (in microvolts) recording during exercise, following the standard recommendations for electrode placement and with signal normalization.
Measured: Baseline, week 9
Muscle electrical activity (frequency)
The MuscleLab system with electromyography will be used to measure muscle electrical activity in vastus lateralis (in Hz) recording during exercise, following the standard recommendations for electrode placement and with signal normalization.
Measured: Baseline, week 9
Muscle electrical activity (amplitude)
The MuscleLab system with electromyography will be used to measure muscle electrical activity in rectus femoris (in microvolts) recording during exercise, following the standard recommendations for electrode placement and with signal normalization.
Measured: Baseline, week 9
Muscle electrical activity (frequency)
The MuscleLab system with electromyography will be used to measure muscle electrical activity in in rectus femoris bilateral (in Hz) recording during exercise, following the standard recommendations for electrode placement and with signal normalization.
Measured: Baseline, week 9
Weight
The change in the weight will be assessed by kilograms (kg).
Measured: Baseline, week 9
Body composition (Bioimpedance)
The change in body composition (%) will be assessed using the NUTRILAB bioimpedance device (AKERN Srl, Florence, Italy). Users will be instructed to remove all metal-containing objects and remain in a supine position on a couch during the measurements, with the legs in 45° abduction, the shoulders in 30° abduction relative to the center of the body and the hands in pronation. After cleaning the skin with alcohol, two adhesive electrodes (Biatrodes Akern Srl, Florence, Italy) will be placed on the surface of the right hand and two on the right foot. The measurement results will be given in different unit measures depending on the specific variable assessed.
Measured: Baseline, week 9.
Muscle thickness
The change in the muscle thickness (in centimeters) of the vastus lateralis will be measured using a real-time B-mode ultrasound device with a linear transducer. A water-soluble, hypoallergenic transmission gel will be applied to the probe, to serve as a conductive interface between the probe and the participant's skin.
Measured: Baseline, week 9.
Muscle thickness
The change in the muscle thickness (in centimeters) of the rectus femoris bilateral will be measured using a real-time B-mode ultrasound device with a linear transducer. A water-soluble, hypoallergenic transmission gel will be applied to the probe, to serve as a conductive interface between the probe and the participant's skin.
Measured: Baseline, week 9.
Pain score
The change in the score of pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 "no pain at all" to 10 "worst pain imaginable."
Measured: Baseline, up to study completion (8 weeks); week 9.
Pain location
The pain location will be assessed using a body chart. The participant will identify using a graphical representation of the body the location of the pain, without indicating its intensity.
Measured: Baseline, up to study completion (8 weeks); week 9.
Quality of life: Short Form 36 Health Survey
The change in quality-of-life scores will be assessed using the Short Form 36 Health Survey (SF-36). This instrument consists of 36 items, organized into eight health domains, with a score ranging from 0 to 100.
Measured: Baseline, week 9.
Quality of life: EuroQOL five dimensions questionnaire
The change in quality-of-life scores will be assessed using the EuroQOL five-dimensions questionnaire (EQ-5D). This instrument consists of five dimensions and a visual analogue scale (VAS).The response types involve a Likert scale (1-5 for dimensions), multiple-choice (selecting the level), and a rating scale (0-100 for VAS).
Measured: Baseline, week 9.
Sleep quality
The change in sleep quality scores will be assessed using the Pittsburgh Sleep Quality Index (PSQI). This index consists of 19 self-rated items, which are grouped into seven component scores, ranging from 0 to 21.
Measured: Baseline, week 9.
Physical activity levels
The levels of physical activity will be recorded using the International Physical Activity Questionnaire (score) a standardized tool that defines and measures physical activity based on frequency (days) and duration (minutes) over a week. It categorizes physical activity into vigorous-intensity, moderate-intensity, and walking, and also assesses time spent sitting.
Measured: Baseline, week 9.
Heart rate variability
The change in heart rate variability (HRV) will be measured in milliseconds (ms) to assess autonomic nervous system function. Participants will use a Polar H10 heart rate monitor (Polar Electro Oy, Kempele, Finland) with the Elite HRV app for 15 minutes.
Measured: Baseline, week 9.
Interleukin-6 (IL-6) levels
The change in the plasma concentration of interleukin-6 (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, week 9.
Tumor necrosis factor-alpha (TNF-α) levels
The change in the plasma concentration of tumor necrosis factor-alpha (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, week 9.
C-reactive protein (CRP) levels
The change in the plasma concentration of C-reactive protein (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, week 9.
Cortisol
Cortisol The change in the plasma concentration of cortisol (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, week 9.
Glucose
The change in the plasma concentration of glucose (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, week 9.
Testosterone (total)
The change in the plasma concentration of total testosterone (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, week 9.
Testosterone (free)
The change in the plasma concentration of free testosterone (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, week 9.
Sex hormone-binding globulin
The change in the plasma concentration of sex hormone-blinding globulin (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, week 9.
Dehydroepiandrosterone sulfate
The change in the plasma concentration of dehydroepiandrosterone sulfate (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, week 9.
Fibromyalgia Impact Questionnaire
The change in the score of the fibromyalgia impact will be assessed using the fibromyalgia impact questionnaire (FIQ), a 10-item questionnaire that covers Physical Function, Work Status, and Symptoms. The total score ranges from 0 to 100, a higher score (closer to 100) indicates a greater impact of fibromyalgia, signifying higher functional disability, more severe symptoms, and a worse quality of life. Conversely, a lower score (closer to 0) indicates a better health status.
Measured: Baseline, week 9.
Nutritional intake: Consume frequency
The change in the dietary intake (consume frequency) will be assessed with a Food Frequency Questionnaire (FFQ). This tool measures how often foods and food groups are consumed over a specific period, enabling the estimation of typical dietary patterns. The total days per week that a participant consumes a type of food will be recorded.
Measured: Baseline, week 9.
Nutritional intake: 24-hour register
The change in the dietary intake will be assessed with a 24-hour dietary recall . This tool measures how often foods and food groups are consumed over a specific period, enabling the estimation of typical dietary patterns.
Measured: Baseline, week 9.
Canadian Occupational Performance Measure
The change in the occupational performance score will we assessed using the Canadian Occupational Performance Measure (COPM). The participant will identify their priorities for activities in daily living. After priorities are identified, each is rated for current performance and satisfaction with current performance on a scale of 1 (not able to do it / not satisfied at all) to 10 (able to do it extremely well / extremely satisfied).
Measured: Baseline, week 9.
Goal Attainment Scaling
The change in the goal achievement progress will be assessed using Goal Attainment Scaling, a standardized individualized outcome measure in which five measurable outcomes are specified for each goal. The total score will range from -2 to 2.
Measured: Baseline, week 9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies 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
- Model description
- Prospective single center randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University Miguel de Cervantes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Santos Lozano, PhD, Principal investigator, Miguel de Cervantes European University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483216
- Sponsor's protocol ID
- PI-DOC012-FibrodEx
- Acronym
- FibrodEx
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Afonso J, Nakamura FY, Baptista I, Rendeiro-Pinho G, Brito J, Figueiredo P. Microdosing: Old Wine in a New Bottle? Current State of Affairs and Future Avenues. Int J Sports Physiol Perform. 2022 Oct 6;17(11):1649-1652. doi: 10.1123/ijspp.2022-0291. Print 2022 Nov 1.
PubMed 36202386Tavares LF, Germano Maciel D, Pereira Barros da Silva TY, Brito Vieira WH. Comparison of functional and isokinetic performance between healthy women and women with fibromyalgia. J Bodyw Mov Ther. 2020 Jan;24(1):248-252. doi: 10.1016/j.jbmt.2019.05.024. Epub 2019 May 23.
PubMed 31987552Voss AC, Chambers TL, Gries KJ, Jemiolo B, Raue U, Minchev K, Begue G, Lee GA, Trappe TA, Trappe SW. Exercise microdosing for skeletal muscle health applications to spaceflight. J Appl Physiol (1985). 2024 May 1;136(5):1040-1052. doi: 10.1152/japplphysiol.00491.2023. Epub 2024 Jan 11.
PubMed 38205550Larsson A, Palstam A, Lofgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia--a randomized controlled trial. Arthritis Res Ther. 2015 Jun 18;17(1):161. doi: 10.1186/s13075-015-0679-1.
PubMed 26084281Albuquerque MLL, Monteiro D, Marinho DA, Vilarino GT, Andrade A, Neiva HP. Effects of different protocols of physical exercise on fibromyalgia syndrome treatment: systematic review and meta-analysis of randomized controlled trials. Rheumatol Int. 2022 Nov;42(11):1893-1908. doi: 10.1007/s00296-022-05140-1. Epub 2022 May 23.
PubMed 35604435Couto N, Monteiro D, Cid L, Bento T. Effect of different types of exercise in adult subjects with fibromyalgia: a systematic review and meta-analysis of randomised clinical trials. Sci Rep. 2022 Jun 20;12(1):10391. doi: 10.1038/s41598-022-14213-x.
PubMed 35725780Estevez-Lopez F, Maestre-Cascales C, Russell D, Alvarez-Gallardo IC, Rodriguez-Ayllon M, Hughes CM, Davison GW, Sanudo B, McVeigh JG. Effectiveness of Exercise on Fatigue and Sleep Quality in Fibromyalgia: A Systematic Review and Meta-analysis of Randomized Trials. Arch Phys Med Rehabil. 2021 Apr;102(4):752-761. doi: 10.1016/j.apmr.2020.06.019. Epub 2020 Jul 25.
PubMed 32721388Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20.
PubMed 29291206
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Microdoses Isokinetic Exercise Protocol in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07483216
- Acronym / sponsor ID
- FibrodEx / PI-DOC012-FibrodEx
- Conditions
- Fibromyalgia (FM)
- Keywords
- Fibromyalgia, Exercise, Isokinetic, Microdosing, Pain, Non-Pharmacological treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- European University Miguel de CervantesUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional impairment, which significantly affects quality of life. Physical exercise is considered one of the most effective non-pharmacological interventions for the management of this condition; however, uncertainty remains regarding the most appropriate type, intensity, and frequency of exercise for different patient profiles. The aim of this study is to analyze the effects of a microdoses isokinetic exercise program on physical condition, perceived pain, inflammatory profile and quality of life in women diagnosed with fibromyalgia.
Detailed description
Physical exercise is one of the non-pharmacological treatments with the strongest evidence and effectiveness in the management of fibromyalgia, as it has been shown to improve muscle strength and, consequently, patients' quality of life. One of the main limitations in this population is low adherence to traditional exercise programs due to chronic pain. Microdoses exercise training emerges as an alternative approach, based on the principle of the minimum effective dose. To implement this intervention, the training program will be conducted using isokinetic exercise, which allows precise control of movement velocity and joint position to ensure safe conditions. Accordingly, the aim of the present study is to evaluate the effects of an isokinetic exercise microdosing program in women with fibromyalgia over an 8-week intervention period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective single center randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseAn isokinetic exercise program of microdosing will be conducted over 8 weeks, with a frequency of three sessions per week, each lasting 20-25 minutes. Participants will also receive information on healthy lifestyle habits. |
| Control group | No intervention | –Participants assigned to the control group will continue with their usual treatment and will receive general recommendations for healthy lifestyle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged ≥ 18 years diagnosed with fibromyalgia according to current clinical criteria.
- Clinical and pharmacological stability during the weeks prior to participation in the study.
- Ability to perform supervised exercise and to complete the assessments.
- Written informed consent.
Key exclusion criteria (3 listed)
- Cardiovascular, neurologic, musculoskeletal or systemic pathology that contraindicate the performance of exercise.
- Significant change in pharmacological treatment during the period immediately preceding the study.
- Any condition that, in clinical judgement, prevents them from following the protocol safely.
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 |
|---|---|---|
| ExerciseParticipants assigned to the experimental group will perform the sessions under supervision. Each session will begin with a warm-up consisting of joint mobility exercises and 5 minutes of low-intensity cycling. This will be followed by the main exercise component, which will consist of one set of five repetitions of knee extension exercise. During the initial sessions, the exercise will be performed at 60°/s, with a gradual and controlled progression up to a maximum of eight repetitions. To finish, participants will complete 5 minutes of stretching and controlled breathing. | Other | Exercise |
Primary outcome
Peak torque
Time frame: Baseline, up to study completion (8 weeks); week 9
The change in the peak torque (in Nm) will be assessed in the concentric part of a knee extension exercise (1x5) at 60º/s using the Biodex System 4.
Peak torque
Time frame: Baseline, up to study completion (8 weeks); week 9
The change in the peak torque (in Nm) will be assessed in the eccentric part of a knee extension exercise (1x5) at 60º/s using the Biodex System 4.
Agonist-antagonist ratio
Time frame: Baseline, up to study completion (8 weeks); week 9
The change in the agonist-antagonist ratio (%) of the knee extension exercise will be assessed using the Biodex System 4.
Total work
Time frame: Baseline, up to study completion (8 weeks); week 9.
The change in the total work (in J) of the knee extension exercise will be assessed using the Biodex System 4.
Height
Time frame: Baseline, week 9
The change in the height will be assessed by centimeters (cm).
29 secondary outcomes
Muscle electrical activity (amplitude)
Time frame: Baseline, week 9
Muscle electrical activity (frequency)
Time frame: Baseline, week 9
Muscle electrical activity (amplitude)
Time frame: Baseline, week 9
Muscle electrical activity (frequency)
Time frame: Baseline, week 9
Weight
Time frame: Baseline, week 9
Body composition (Bioimpedance)
Time frame: Baseline, week 9.
Muscle thickness
Time frame: Baseline, week 9.
Muscle thickness
Time frame: Baseline, week 9.
Pain score
Time frame: Baseline, up to study completion (8 weeks); week 9.
Pain location
Time frame: Baseline, up to study completion (8 weeks); week 9.
Quality of life: Short Form 36 Health Survey
Time frame: Baseline, week 9.
Quality of life: EuroQOL five dimensions questionnaire
Time frame: Baseline, week 9.
Sleep quality
Time frame: Baseline, week 9.
Physical activity levels
Time frame: Baseline, week 9.
Heart rate variability
Time frame: Baseline, week 9.
Interleukin-6 (IL-6) levels
Time frame: Baseline, week 9.
Tumor necrosis factor-alpha (TNF-α) levels
Time frame: Baseline, week 9.
C-reactive protein (CRP) levels
Time frame: Baseline, week 9.
Cortisol
Time frame: Baseline, week 9.
Glucose
Time frame: Baseline, week 9.
Testosterone (total)
Time frame: Baseline, week 9.
Testosterone (free)
Time frame: Baseline, week 9.
Sex hormone-binding globulin
Time frame: Baseline, week 9.
Dehydroepiandrosterone sulfate
Time frame: Baseline, week 9.
Fibromyalgia Impact Questionnaire
Time frame: Baseline, week 9.
Nutritional intake: Consume frequency
Time frame: Baseline, week 9.
Nutritional intake: 24-hour register
Time frame: Baseline, week 9.
Canadian Occupational Performance Measure
Time frame: Baseline, week 9.
Goal Attainment Scaling
Time frame: Baseline, week 9.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 36202386Afonso J, Nakamura FY, Baptista I, Rendeiro-Pinho G, Brito J, Figueiredo P. Microdosing: Old Wine in a New Bottle? Current State of Affairs and Future Avenues. Int J Sports Physiol Perform. 2022 Oct 6;17(11):1649-1652. doi: 10.1123/ijspp.2022-0291. Print 2022 Nov 1.
- Background: PubMed 31987552Tavares LF, Germano Maciel D, Pereira Barros da Silva TY, Brito Vieira WH. Comparison of functional and isokinetic performance between healthy women and women with fibromyalgia. J Bodyw Mov Ther. 2020 Jan;24(1):248-252. doi: 10.1016/j.jbmt.2019.05.024. Epub 2019 May 23.
- Background: PubMed 38205550Voss AC, Chambers TL, Gries KJ, Jemiolo B, Raue U, Minchev K, Begue G, Lee GA, Trappe TA, Trappe SW. Exercise microdosing for skeletal muscle health applications to spaceflight. J Appl Physiol (1985). 2024 May 1;136(5):1040-1052. doi: 10.1152/japplphysiol.00491.2023. Epub 2024 Jan 11.
- Background: PubMed 26084281Larsson A, Palstam A, Lofgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia--a randomized controlled trial. Arthritis Res Ther. 2015 Jun 18;17(1):161. doi: 10.1186/s13075-015-0679-1.
- Background: PubMed 35604435Albuquerque MLL, Monteiro D, Marinho DA, Vilarino GT, Andrade A, Neiva HP. Effects of different protocols of physical exercise on fibromyalgia syndrome treatment: systematic review and meta-analysis of randomized controlled trials. Rheumatol Int. 2022 Nov;42(11):1893-1908. doi: 10.1007/s00296-022-05140-1. Epub 2022 May 23.
- Background: PubMed 35725780Couto N, Monteiro D, Cid L, Bento T. Effect of different types of exercise in adult subjects with fibromyalgia: a systematic review and meta-analysis of randomised clinical trials. Sci Rep. 2022 Jun 20;12(1):10391. doi: 10.1038/s41598-022-14213-x.
- Background: PubMed 32721388Estevez-Lopez F, Maestre-Cascales C, Russell D, Alvarez-Gallardo IC, Rodriguez-Ayllon M, Hughes CM, Davison GW, Sanudo B, McVeigh JG. Effectiveness of Exercise on Fatigue and Sleep Quality in Fibromyalgia: A Systematic Review and Meta-analysis of Randomized Trials. Arch Phys Med Rehabil. 2021 Apr;102(4):752-761. doi: 10.1016/j.apmr.2020.06.019. Epub 2020 Jul 25.
- Background: PubMed 29291206Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20.
- Individual participant dataSharing planned: No
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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.
Alejandro Santos Lozano, PhD principal investigator
Miguel de Cervantes European University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Fibromyalgia (FM), run by European University Miguel de Cervantes 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Santos Lozano, PhD (0034983001000 ext. 22292, asantos@uemc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak torque (time frame: Baseline, up to study completion (8 weeks); week 9). The study lists 5 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 NCT07483216, which also lists 8 linked publications.
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 16 Apr 2026.