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A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia

A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03682588
Enrollment
82
Registered
2018-09-24
Start date
2018-10-01
Completion date
2020-01-06
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Exercise, Functional training

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.

Interventions

OTHERPhysical 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.

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Randomised electronically generated randomisation table. Secret allocation (sealed opaque envelopes).

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in painBaseline, after 7, 14, 26 and 38 weeksEvaluated using the Visual Analogue Scale for pain. Scores ranges from 0 to 10 with higher values represent a worse pain.

Secondary

MeasureTime frameDescription
Change in Muscular StrengthBaseline, after 7, 14, 26 and 38 weeksEvaluated using the one-repetition maximum test
Change in functional performanceBaseline, after 7, 14, 26 and 38 weeksEvaluated using the Time-up and go test
Change in balanceBaseline, after 7, 14, 26 and 38 weeksEvaluated using the Berg balance scale to evaluate balance. Scores ranges from 0 to 56 with higher values represent a worse balance.
Change in FlexibilityBaseline, after 7, 14, 26 and 38 weeksEvaluated using the sit and reach test (Wells Bench)
Change in General quality of lifeBaseline, after 7, 14, 26 and 38 weeksEvaluated 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..
Change in medications consumptionBaseline, after 7, 14, 26 and 38 weeksEvaluated the amount of acetominophen (500mg de 6/6 hours) used for pain
Change in health-related quality of lifeBaseline, after 7, 14, 26 and 38 weeksEvaluated using the Fibromyalgia Impact Questionnaire. Scores ranges from 0 to 100 with higher values represent a worse quality of life..

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026