A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Other: Physical activity
- Registration Number
- NCT03682588
- Lead Sponsor
- Federal University of São Paulo
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 82
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stretching exercise group 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 Functional exercise group Physical activity Functional exercise program with 14 exercises, two times/week, during 14 weeks. Two sets of 10 repetitions each, with 30 seconds interval.
- Primary Outcome Measures
Name Time Method Change in pain 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.
- Secondary Outcome Measures
Name Time Method Change in functional performance Baseline, after 7, 14, 26 and 38 weeks Evaluated using the Time-up and go test
Change in balance Baseline, after 7, 14, 26 and 38 weeks Evaluated using the Berg balance scale to evaluate balance. Scores ranges from 0 to 56 with higher values represent a worse balance.
Change in health-related quality of life Baseline, after 7, 14, 26 and 38 weeks Evaluated using the Fibromyalgia Impact Questionnaire. Scores ranges from 0 to 100 with higher values represent a worse quality of life..
Change in Flexibility Baseline, after 7, 14, 26 and 38 weeks Evaluated using the sit and reach test (Wells Bench)
Change in medications consumption Baseline, after 7, 14, 26 and 38 weeks Evaluated the amount of acetominophen (500mg de 6/6 hours) used for pain
Change in Muscular Strength Baseline, after 7, 14, 26 and 38 weeks Evaluated using the one-repetition maximum test
Change in General quality of life Baseline, after 7, 14, 26 and 38 weeks 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..
Trial Locations
- Locations (1)
Rheumatology outpatient clinics of a university hospital;
🇧🇷São Paulo, SP, Brazil