FibromyalgiaFIBROMUEVENCT07913893
Multicomponent Exercise and Pain Neuroscience Education in Women With Fibromyalgia
A study testing Multicomponent Exercise in people with Fibromyalgia, run by Cristian Omar Gálvez Rodríguez at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Multicomponent Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChile
- Study dates
- 10 Jun 2025to 2 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Clinically confirmed diagnosis of fibromyalgia according to American College of Rheumatology (ACR) diagnostic criteria.
- Willingness and availability to attend weekly group sessions throughout the 12-week intervention.
- Ability to perform functional assessments and complete self-reported questionnaires.
- Provision of written informed consent.
Who cannot join
- Severe or uncontrolled medical or psychiatric conditions that could interfere with participation or pose safety risks during exercise.
- Recent changes in pharmacological treatment that could substantially influence clinical status or study outcomes, including changes in psychotropic medications or systemic corticosteroids.
- Significant cognitive, comprehension, or communication difficulties that could prevent independent participation in the intervention or completion of assessments.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Community-Based Study Site (Name Withheld for Confidentiality)
Puente Alto, Santiago Metropolitan, 8240000
About this study
Official title: Fibromueve: aproximación terapéutica Para Personas Con Fibromialgia
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Fibromyalgia
- Being tested
- Multicomponent Exercise
- Keywords
- Multicomponent Exercise, Pain Neuroscience Education, Exercise Therapy, Physical Function, Quality of Life
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants received a 12-week, community-based group program combining multicomponent exercise and | Experimental | 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 Receives: Behavioral: Multicomponent Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0), Week 6, and Week 12
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0), Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start10 Jun 2025
- Primary completion2 Sep 2025
- Study completion2 Sep 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristian Omar Gálvez Rodríguez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cristian Omar Gálvez Rodríguez, University of Americas - Chili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913893
- Sponsor's protocol ID
- CEC_FP_2025018
- Acronym
- FIBROMUEVE
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromueve: aproximación terapéutica Para Personas Con Fibromialgia
- ClinicalTrials.gov ID
- NCT07913893
- Acronym / sponsor ID
- FIBROMUEVE / CEC_FP_2025018
- Conditions
- Fibromyalgia
- Keywords
- Multicomponent Exercise, Pain Neuroscience Education, Exercise Therapy, Physical Function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cristian Omar Gálvez RodríguezUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 3 Nov 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants received a 12-week, community-based group program combining multicomponent exercise and | Experimental | Behavioral: Multicomponent ExerciseParticipants 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years.
- Clinically confirmed diagnosis of fibromyalgia according to American College of Rheumatology (ACR) diagnostic criteria.
- Willingness and availability to attend weekly group sessions throughout the 12-week intervention.
- Ability to perform functional assessments and complete self-reported questionnaires.
- Provision of written informed consent.
Key exclusion criteria (3 listed)
- Severe or uncontrolled medical or psychiatric conditions that could interfere with participation or pose safety risks during exercise.
- Recent changes in pharmacological treatment that could substantially influence clinical status or study outcomes, including changes in psychotropic medications or systemic corticosteroids.
- Significant cognitive, comprehension, or communication difficulties that could prevent independent participation in the intervention or completion of assessments.
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 |
|---|---|---|
| Multicomponent ExerciseParticipants 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. | Behavioural | Participants received a 12-week, community-based group program combining multicomponent exercise and |
Primary outcome
Change in 1-Minute Sit-to-Stand Test Performance
Time frame: Baseline (Week 0), Week 6, and Week 12
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.
Change in Dominant-Hand Handgrip Strength
Time frame: Baseline (Week 0), Week 6, and Week 12
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.
11 secondary outcomes
Change in Pain Intensity (Numeric Rating Scale)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Fibromyalgia Impact (FIQR)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Health-Related Quality of Life (SF-36)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Multidimensional Fatigue (MFI-20)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Physical Activity Level (IPAQ-SF)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Pain Catastrophizing (PCS)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Fear of Movement (TSK-11)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Anxiety Symptoms (HADS-A)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Depressive Symptoms (HADS-D)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Perceived Stress (PSS)
Time frame: Baseline (Week 0), Week 6, and Week 12
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 3 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Exercise in people with Fibromyalgia, run by Cristian Omar Gálvez Rodríguez at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 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: finished, as of the sponsor's last update on 3 Nov 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 Chile. 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?
Change in 1-Minute Sit-to-Stand Test Performance (time frame: Baseline (Week 0), Week 6, and Week 12). The study lists 2 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 3 Nov 2026.