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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, CEP 04039-002
      • Rheumatology outpatient clinics of a university hospital;

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional exercise group; 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; 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
Active Comparator: Stretching exercise group; 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.; Other Names: Functional exercise group and Stretching exercise group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Evaluated using the Visual Analogue Scale for pain. Scores ranges from 0 to 10 with higher values represent a worse pain.	Baseline, after 7, 14, 26 and 38 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscular Strength	Evaluated using the one-repetition maximum test	Baseline, after 7, 14, 26 and 38 weeks
Change in functional performance	Evaluated using the Time-up and go test	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.	Baseline, after 7, 14, 26 and 38 weeks
Change in Flexibility	Evaluated using the sit and reach test (Wells Bench)	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..	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	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..	Baseline, after 7, 14, 26 and 38 weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Study Director: Jamil Natour, Professor, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): September 2, 2019
• Study Completion (Actual): January 6, 2020

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Fibromyalgia; Functional training
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 719.779

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No