Skip to main content
OpenTrials
Completed

NCT Number: NCT03682588

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rheumatology outpatient clinics of a university hospital;

São Paulo, CEP 04039-002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Other

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.

Other names: Functional exercise group and Stretching exercise group

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Muscular Strength

    Time frame: Baseline, after 7, 14, 26 and 38 weeks

    Evaluated using the one-repetition maximum test

  2. Change in functional performance

    Time frame: Baseline, after 7, 14, 26 and 38 weeks

    Evaluated using the Time-up and go test

  3. Change in balance

    Time frame: 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.

  4. Change in Flexibility

    Time frame: Baseline, after 7, 14, 26 and 38 weeks

    Evaluated using the sit and reach test (Wells Bench)

  5. Change in General quality of life

    Time frame: 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..

  6. Change in medications consumption

    Time frame: Baseline, after 7, 14, 26 and 38 weeks

    Evaluated the amount of acetominophen (500mg de 6/6 hours) used for pain

  7. Change in health-related quality of life

    Time frame: 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..

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 24, 2018
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.