FibromyalgiaNCT03682588
A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia
A study testing Physical activity in people with Fibromyalgia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Fibromyalgia is a syndrome characterized mainly by chronic generalized pain that affects the physical fitness and functional capacity of patients. There is increasing evidence of the benefits of physical exercise in improving fibromyalgia symptoms, making these interventions part of therapeutic arsenal. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 6 Jan 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex
- Classification of fibromyalgia based on the criteria of the American College of Rheumatology
- Age 18 to 65 years;
- Pain intensity between 4 and 8cm on a visual analog scale ranging from 0 to 10cm
- Stable medication for at least three months
Who cannot join
- Uncontrolled cardiorespiratory disease
- Health condition for which physical exercise was contraindicated
- Serious psychiatric disorder
- Uncontrolled diabetes mellitus
- Inflammatory rheumatic disease
- History of regular physical exercise (30min, 3 times a week) in the previous 3 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rheumatology outpatient clinics of a university hospital;
São Paulo, São Paulo, CEP 04039-002
About this study
Official title: A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia: A Randomized Controlled Trial
Fibromyalgia is a syndrome characterized mainly by chronic generalized pain that affects the physical fitness and functional capacity of patients. There is increasing evidence of the benefits of physical exercise in improving fibromyalgia symptoms, making these interventions part of therapeutic arsenal. Objective: To evaluate the effectiveness of a program of functional exercises in reducing pain, improving functional capacity, increasing muscle strength, improving flexibility, balance and quality of life of patients with fibromyalgia. Intervention: The intervention group performed functional physical training for 45 minutes twice a week for 14 weeks. The control group will perform stretching exercises with the same duration and frequency. evaluation instruments: Visual Analog Scale for pain; Fibromyalgia Impact Questionnaire; Time-up and go test; 1Repetitian Maximum test; Sit and reach test; Berg Balance Scale; and Short Form-36 and amount of analgesics used during the intervention period was evaluated.
Read the detailed description
Fibromyalgia is a syndrome characterized mainly by chronic generalized pain that affects the physical fitness and the functional capacity of patients. There is growing evidence of the benefits of exercise to improve fibromyalgia symptoms, making these interventions part of the therapeutic arsenal. Objective: To evaluate the effectiveness of a functional exercise program in reducing pain, improving functional capacity, increasing muscle strength, improving flexibility, balance and quality of life of patients with fibromyalgia. METHODS: This was a randomized controlled trial with blind evaluator. 82 female patients with fibromyalgia were included, aged between 18 and 65 years, randomized into two groups, intervention and control. The intervention group performed functional physical training for 45 minutes twice a week for 14 weeks. The control group performed stretching exercises with the same duration and frequency. The evaluation instruments were: Visual Analog Scale for pain evaluation; Fibromyalgia Impact Questionnaire, to evaluate health-related quality of life; Time-up and go test for functional performance assessment; 1Repetitium Maximum, for evaluation of muscle strength; sit and reach test for the assessment of flexibility; Berg Balance Scale, to assess balance; and Short Form-36 to assess overall quality of life. In addition, the amount of analgesics used during the intervention period was evaluated.
- Conditions
- Fibromyalgia
- Being tested
- Physical activity
- Keywords
- Fibromyalgia, Exercise, Functional training
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Also called Functional exercise group and Stretching exercise group
The Functional exercise group performed functional exercise training for 45 minutes twice a week for 14 weeks. The Stretching exercise group performed stretching exercises with the same duration and frequency.
| Study group | Role | What they receive |
|---|---|---|
| Functional exercise group | Experimental | Functional exercise program with 14 exercises, two times/week, during 14 weeks. Two sets of 10 repetitions each, with 30 seconds interval. Receives: Other: Physical activity |
| Stretching exercise group | Active comparator | Stretching exercise program with 17 exercises, two times/week, during 14 weeks and each movement was repeated by three times and held for 20 seconds each Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Evaluated using the Visual Analogue Scale for pain. Scores ranges from 0 to 10 with higher values represent a worse pain.
Measured: Baseline, after 7, 14, 26 and 38 weeks
Secondary outcomes (7)
Change in Muscular Strength
Evaluated using the one-repetition maximum test
Measured: Baseline, after 7, 14, 26 and 38 weeks
Change in functional performance
Evaluated using the Time-up and go test
Measured: Baseline, after 7, 14, 26 and 38 weeks
Change in balance
Evaluated using the Berg balance scale to evaluate balance. Scores ranges from 0 to 56 with higher values represent a worse balance.
Measured: Baseline, after 7, 14, 26 and 38 weeks
Change in Flexibility
Evaluated using the sit and reach test (Wells Bench)
Measured: Baseline, after 7, 14, 26 and 38 weeks
Change in General quality of life
Evaluated using the Short-form 36 questionnaire for quality of life. Scores ranges from 0 to 100 with higher values represent a better quality of life..
Measured: Baseline, after 7, 14, 26 and 38 weeks
Change in medications consumption
Evaluated the amount of acetominophen (500mg de 6/6 hours) used for pain
Measured: Baseline, after 7, 14, 26 and 38 weeks
Change in health-related quality of life
Evaluated using the Fibromyalgia Impact Questionnaire. Scores ranges from 0 to 100 with higher values represent a worse quality of life..
Measured: Baseline, after 7, 14, 26 and 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Oct 2018
- Primary completion2 Sep 2019
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovana Fernandes, Federal University of São Paulo
- Investigators
- Jamil Natour, Professor, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682588
- Sponsor's protocol ID
- 719.779
- Status last verified
- Sep 2023
- First submitted
- 3 Aug 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernandes G, Nery M, Meireles SM, Santos R, Natour J, Jennings F. A functional exercise program improves pain and health related quality of life in patients with fibromyalgia: a randomized controlled trial. Adv Rheumatol. 2024 Oct 24;64(1):81. doi: 10.1186/s42358-024-00422-7.
PubMed 39449056
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03682588
- Acronym / sponsor ID
- 719.779
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Exercise, Functional training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 24 Sep 2018 (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 syndrome characterized mainly by chronic generalized pain that affects the physical fitness and functional capacity of patients. There is increasing evidence of the benefits of physical exercise in improving fibromyalgia symptoms, making these interventions part of therapeutic arsenal. Objective: To evaluate the effectiveness of a program of functional exercises in reducing pain, improving functional capacity, increasing muscle strength, improving flexibility, balance and quality of life of patients with fibromyalgia. Intervention: The intervention group performed functional physical training for 45 minutes twice a week for 14 weeks. The control group will perform stretching exercises with the same duration and frequency. evaluation instruments: Visual Analog Scale for pain; Fibromyalgia Impact Questionnaire; Time-up and go test; 1Repetitian Maximum test; Sit and reach test; Berg Balance Scale; and Short Form-36 and amount of analgesics used during the intervention period was evaluated.
Detailed description
Fibromyalgia is a syndrome characterized mainly by chronic generalized pain that affects the physical fitness and the functional capacity of patients. There is growing evidence of the benefits of exercise to improve fibromyalgia symptoms, making these interventions part of the therapeutic arsenal. Objective: To evaluate the effectiveness of a functional exercise program in reducing pain, improving functional capacity, increasing muscle strength, improving flexibility, balance and quality of life of patients with fibromyalgia. METHODS: This was a randomized controlled trial with blind evaluator. 82 female patients with fibromyalgia were included, aged between 18 and 65 years, randomized into two groups, intervention and control. The intervention group performed functional physical training for 45 minutes twice a week for 14 weeks. The control group performed stretching exercises with the same duration and frequency. The evaluation instruments were: Visual Analog Scale for pain evaluation; Fibromyalgia Impact Questionnaire, to evaluate health-related quality of life; Time-up and go test for functional performance assessment; 1Repetitium Maximum, for evaluation of muscle strength; sit and reach test for the assessment of flexibility; Berg Balance Scale, to assess balance; and Short Form-36 to assess overall quality of life. In addition, the amount of analgesics used during the intervention period was evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Functional exercise group | Experimental | Other: Physical activityFunctional exercise program with 14 exercises, two times/week, during 14 weeks. Two sets of 10 repetitions each, with 30 seconds interval. |
| Stretching exercise group | Active comparator | Other: Physical activityStretching exercise program with 17 exercises, two times/week, during 14 weeks and each movement was repeated by three times and held for 20 seconds each |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female sex
- Classification of fibromyalgia based on the criteria of the American College of Rheumatology
- Age 18 to 65 years;
- Pain intensity between 4 and 8cm on a visual analog scale ranging from 0 to 10cm
- Stable medication for at least three months
Key exclusion criteria (6 listed)
- Uncontrolled cardiorespiratory disease
- Health condition for which physical exercise was contraindicated
- Serious psychiatric disorder
- Uncontrolled diabetes mellitus
- Inflammatory rheumatic disease
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 |
|---|---|---|
| Physical activityAlso: Functional exercise group and Stretching exercise groupThe Functional exercise group performed functional exercise training for 45 minutes twice a week for 14 weeks. The Stretching exercise group performed stretching exercises with the same duration and frequency. | Other | Functional exercise group, Stretching exercise group |
Primary outcome
Change in pain
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Evaluated using the Visual Analogue Scale for pain. Scores ranges from 0 to 10 with higher values represent a worse pain.
7 secondary outcomes
Change in Muscular Strength
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Change in functional performance
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Change in balance
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Change in Flexibility
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Change in General quality of life
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Change in medications consumption
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Change in health-related quality of life
Time frame: Baseline, after 7, 14, 26 and 38 weeks
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 28 Sep 2023.
- Derived from this study: PubMed 39449056Fernandes G, Nery M, Meireles SM, Santos R, Natour J, Jennings F. A functional exercise program improves pain and health related quality of life in patients with fibromyalgia: a randomized controlled trial. Adv Rheumatol. 2024 Oct 24;64(1):81. doi: 10.1186/s42358-024-00422-7.
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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.
Jamil Natour, Professor study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Fibromyalgia, run by Federal University of São Paulo at 1 site in Brazil.
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 6 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 28 Sep 2023. 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 Brazil. 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 pain (time frame: Baseline, after 7, 14, 26 and 38 weeks). 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 NCT03682588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.