FibromyalgiaNCT03588208
Progressive Resistance Training for Fibromyalgia
A study testing Progressive resistance training program and Educational Program in people with Fibromyalgia, run by Federal University of São Paulo.
Trial summary
Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Progressive resistance training program and Educational Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 25 Mar 2018
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;
- Feminine gender;
- Age between 18 and 65 years;
- Pain between 3 and 8 cm in the Numerical Pain Scale (END);
- Have not changed treatment for fibromyalgia in the past three months;
- Agree to participate in the study and sign the informed consent form.
Who cannot join
- Cognitive deficit that does not allow the understanding of the evaluation instruments;
- Other diseases that make it impossible to perform the exercises;
- Physical activity started or changed in the last three months;
- Physical therapy in the last six months;
- In litigation.
About this study
Official title: Evaluation of the Effectiveness of a Progressive Resistance Training Program for Patients With Fibromyalgia: a Randomized Controlled Trial
Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks. Patients in the control group performed the same education program.
- Conditions
- Fibromyalgia
- Being tested
- Progressive resistance training program, Educational Program
- Keywords
- Fibromyalgia, Pain, Function, Quality of life
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance training programOther
Progressive resistance training program were performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training.
Educational ProgramOther
Structured education program were performed during one hour class once a week for five weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: Progressive resistance training program; Other: Educational Program |
| Control Group | Active comparator | Not described Receives: Other: Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Measured by numerical pain scale
Measured: Baseline and after 6 and 12 weeks
Secondary outcomes (4)
Change in Health related quality of life
Measured by Fibromyalgia Impact Questionnaire
Measured: Baseline and after 6 and 12 weeks
Change in Generic quality of life
Measured by the Medical Outcome Survey Short Form 36
Measured: Baseline and after 6 and 12 weeks
Change in Functional capacity
Measured by the 6-minute Walk Test
Measured: Baseline and after 6 and 12 weeks
Change in strength
Measured by the 1 repetition maximum
Measured: Baseline and after 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Feb 2016
- Primary completion2 Sep 2017
- Study completion25 Mar 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anamaria Jones, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588208
- Sponsor's protocol ID
- CEP UNIFESP 482056
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Progressive Resistance Training Program for Patients With Fibromyalgia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03588208
- Acronym / sponsor ID
- CEP UNIFESP 482056
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain, Function, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 2 Sep 2017 (actual)
- Study completion
- 25 Mar 2018 (actual)
- First posted
- 17 Jul 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.
Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks. Patients in the control group performed the same education program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Progressive resistance training program, Other: Educational Program |
| Control Group | Active comparator | Other: Educational Program |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;
- Feminine gender;
- Age between 18 and 65 years;
- Pain between 3 and 8 cm in the Numerical Pain Scale (END);
- Have not changed treatment for fibromyalgia in the past three months;
Key exclusion criteria (5 listed)
- Cognitive deficit that does not allow the understanding of the evaluation instruments;
- Other diseases that make it impossible to perform the exercises;
- Physical activity started or changed in the last three months;
- Physical therapy in the last six months;
- In litigation.
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 |
|---|---|---|
| Progressive resistance training programProgressive resistance training program were performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training. | Other | Intervention Group |
| Educational ProgramStructured education program were performed during one hour class once a week for five weeks | Other | Control Group, Intervention Group |
Primary outcome
Change in pain
Time frame: Baseline and after 6 and 12 weeks
Measured by numerical pain scale
4 secondary outcomes
Change in Health related quality of life
Time frame: Baseline and after 6 and 12 weeks
Change in Generic quality of life
Time frame: Baseline and after 6 and 12 weeks
Change in Functional capacity
Time frame: Baseline and after 6 and 12 weeks
Change in strength
Time frame: Baseline and after 6 and 12 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 17 Jul 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance training program and Educational Program in people with Fibromyalgia, run by Federal University of São Paulo.
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 6 inclusion and 5 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 and after 6 and 12 weeks). 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 17 Jul 2018.