An interventional study of Multicomponent Exercise in Fibromyalgia, sponsored by Cristian Omar Gálvez Rodríguez. Completed at 1 site in Chile. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Cristian Omar Gálvez Rodríguez · Not applicable, Interventional, and Treatment
Fibromyalgia is a long-term condition that causes widespread pain, fatigue, sleep difficulties, and limitations in daily activities. Exercise and education about pain may help people manage these symptoms, but more information is needed about programs delivered in community settings.
The purpose of this study was to evaluate changes in physical function, pain, quality of life, and other health-related outcomes following a 12-week group program combining multicomponent exercise and pain neuroscience education in adults with fibromyalgia.
Participants attended one weekly session that included education about persistent pain and supervised exercises designed to improve strength, endurance, balance, and mobility. Assessments were planned before the program, at week 6, and at week 12. Attendance and responses to exercise were also monitored.
The researchers expected improvements in physical function, pain-related symptoms, and quality of life. The study involved one group of participants without a comparison group, so it was designed to explore changes during the program rather than establish whether the intervention caused those changes.
FIBROMUEVE was a community-based, single-group, quasi-experimental study conducted in Chile to examine changes in physical function, health-related quality of life, and biopsychosocial variables following a 12-week intervention combining multicomponent exercise and pain neuroscience education in adults with fibromyalgia.
The study was developed in collaboration with a community organization supporting people with fibromyalgia. It used a non-randomized, uncontrolled, repeated-measures design, with assessments scheduled at baseline (week 0), mid-intervention (week 6), and post-intervention (week 12).
The intervention consisted of one supervised 120-minute group session per week. Each session included approximately 60 minutes of pain neuroscience education and 60 minutes of multicomponent exercise.
The educational component addressed persistent pain from a biopsychosocial perspective, including pain mechanisms, symptom flare-ups, coping strategies, pain-related beliefs, and self-management approaches.
The exercise component incorporated aerobic activities, lower- and upper-limb strengthening, balance training, and mobility exercises delivered through supervised exercise stations. Exercise intensity and progression were adapted according to participants' symptoms and individual tolerance. Pain intensity and perceived exertion were monitored during sessions to support safe participation and guide exercise modifications.
The study protocol included objective assessments of physical function using the 1-minute sit-to-stand test and handgrip dynamometry. Additional planned assessments addressed pain intensity, fibromyalgia impact, health-related quality of life, fatigue, sleep quality, physical activity, pain catastrophizing, fear of movement, and symptoms of anxiety and depression.
A further objective was to explore the relationship between program adherence, including session attendance, and changes in clinical and functional outcomes.
The study was designed to provide preliminary evidence about the implementation of an integrated exercise and pain education program in a community setting. Because it did not include randomization or a control group, observed changes could not be attributed exclusively to the intervention.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →This is the only study on the registry with Cristian Omar Gálvez Rodríguez as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received a 12-week, community-based group program combining multicomponent exercise and pain neuroscience education. Each weekly 120-minute session included approximately 60 minutes of education about persistent pain and self-management and 60 minutes of supervised exercise involving aerobic activities, upper- and lower-limb strengthening, balance, and mobility. Exercises were adapted according to individual tolerance. Pain intensity (NRS 0-10) and perceived exertion (Borg CR10) were monitored to guide exercise adaptations and safety. No comparator group was included. Copiar descripción
Behavioral: Multicomponent Exercise
Participants attended supervised multicomponent exercise sessions once weekly for 12 weeks, with approximately 60 minutes of exercise per session. Each session included a 10-minute warm-up, a 40-minute circuit comprising aerobic activities, lower-limb strengthening, upper-limb strengthening, and balance training, followed by a 10-minute cool-down. The circuit consisted of four stations, with 8 minutes of exercise and 2 minutes for rest and rotation at each station. Exercise intensity was individually adapted according to pain intensity (NRS 0-10) and perceived exertion (Borg CR10). Sessions were supervised by final-year kinesiology students under the oversight of a licensed kinesiologist.
Change in 1-Minute Sit-to-Stand Test Performance
Lower-limb functional performance was assessed using the 1-minute sit-to-stand test (1-min STS). Participants were instructed to complete as many full sit-to-stand repetitions as possible in 60 seconds using a standardized armless chair. The outcome was the number of correctly completed repetitions. Higher values indicate better functional performance. Changes were assessed across three time points.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Dominant-Hand Handgrip Strength
Handgrip strength was measured using a Jamar hydraulic hand dynamometer. Three maximal voluntary contraction trials were performed with the dominant hand, with rest intervals between attempts. The highest recorded value was used for analysis and expressed in kilograms (kg). Higher values indicate greater handgrip strength. Changes were assessed across three time points.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Pain Intensity (Numeric Rating Scale)
Pain intensity measured using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes from baseline were planned to be assessed at weeks 6 and 12.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Fibromyalgia Impact (FIQR)
Fibromyalgia impact assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR). The total score ranges from 0 to 100 and reflects physical function, overall impact, and symptoms. Higher scores indicate greater disease impact and worse health status.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Health-Related Quality of Life (SF-36)
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Eight health domains are scored from 0 to 100. Higher scores indicate better perceived health status. Changes in domain scores were planned to be assessed over time.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, calculated from seven components of sleep quality. Higher scores indicate poorer sleep quality.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Multidimensional Fatigue (MFI-20)
Fatigue assessed using the 20-item Multidimensional Fatigue Inventory (MFI-20), which measures general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each subscale ranges from 4 to 20, with higher scores indicating greater fatigue or impairment.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Physical Activity Level (IPAQ-SF)
Self-reported physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Walking, moderate-intensity, and vigorous-intensity activities during the preceding seven days are used to classify physical activity as low, moderate, or high according to IPAQ scoring guidelines.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Pain Catastrophizing (PCS)
Pain-related catastrophic thinking assessed using the Pain Catastrophizing Scale (PCS). The total score ranges from 0 to 52 and includes rumination, magnification, and helplessness components. Higher scores indicate greater pain catastrophizing.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Fear of Movement (TSK-11)
Fear of movement and reinjury assessed using the 11-item Tampa Scale for Kinesiophobia (TSK-11). Total scores range from 11 to 44. Higher scores indicate greater fear of movement.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Anxiety Symptoms (HADS-A)
Anxiety symptoms assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The seven-item subscale has a total score ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Depressive Symptoms (HADS-D)
Depressive symptoms assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The seven-item subscale has a total score ranging from 0 to 21. Higher scores indicate more severe depressive symptoms.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Perceived Stress (PSS)
Perceived stress assessed using the Perceived Stress Scale (PSS), which measures the extent to which situations in daily life are perceived as stressful. Higher total scores indicate greater perceived stress. The scoring range must be confirmed against the version of the questionnaire used in this study.
Time frame: Baseline (Week 0), Week 6, and Week 12
Program Attendance and Adherence Rate
Program adherence was assessed by recording the number of weekly group sessions attended by each participant out of 12 scheduled sessions. Attendance was expressed as the total number of sessions attended (0-12) and as a percentage of the 12 scheduled sessions. Higher percentages indicate greater program attendance.
Time frame: Weekly during the 12-week intervention (Weeks 1-12); final adherence calculated at Week 12.
Perceived Exertion During Exercise (Borg CR10 Scale)
Perceived exertion was monitored during supervised exercise sessions using the modified Borg Category-Ratio 10 scale (CR10), ranging from 0 (no exertion) to 10 (maximal exertion). Ratings were recorded during or at the end of the exercise component to assess exercise intensity, monitor tolerance, and guide individual exercise adaptations. Higher scores indicate greater perceived exertion.
Time frame: Each weekly exercise session during the 12-week intervention (Weeks 1-12).
Post-Exercise Pain Intensity During Weekly Sessions (NRS)
Pain intensity was monitored using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain ratings were collected immediately after the exercise component of each weekly session to assess symptom responses and exercise tolerance. Higher scores indicate greater pain intensity. Ratings were used to guide exercise modifications and safety monitoring throughout the program.
Time frame: Immediately after exercise at each weekly session during the 12-week intervention (Weeks 1-12).
Plan to share: No — Individual participant data will not be shared due to ethical and confidentiality considerations. The small sample size and community-based nature of the study may increase the risk of participant re-identification, even after data de-identification. Aggregate study findings will be reported in scientific publications.
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Sep 2025, 2 months.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 2 months is below that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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