An interventional study of Physical activity in Fibromyalgia, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
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.
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.
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's enrollment of 82 is above the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Federal University of São Paulo is the lead sponsor of 438 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Functional exercise program with 14 exercises, two times/week, during 14 weeks. Two sets of 10 repetitions each, with 30 seconds interval.
Other: Physical activity
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
Other: Physical activity
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.
Also known as: Functional exercise group and Stretching exercise group
Change in pain
Evaluated using the Visual Analogue Scale for pain. Scores ranges from 0 to 10 with higher values represent a worse pain.
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Change in Muscular Strength
Evaluated using the one-repetition maximum test
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Change in functional performance
Evaluated using the Time-up and go test
Time frame: 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.
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Change in Flexibility
Evaluated using the sit and reach test (Wells Bench)
Time frame: 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..
Time frame: 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
Time frame: 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..
Time frame: Baseline, after 7, 14, 26 and 38 weeks
Ran from Oct 2018 to primary completion in Sep 2019, 11 months.
Of 510 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 11 months is below that.
Counting every sponsor, half of 522 studies reached it within 13 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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