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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682588
• Other study ID #: 719.779
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 6, 2020

Study information

• Verified date: September 2023
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 6, 2020
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Brazil	Rheumatology outpatient clinics of a university hospital;	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Muscular Strength	Evaluated using the one-repetition maximum test	Baseline, after 7, 14, 26 and 38 weeks
Secondary	Change in functional performance	Evaluated using the Time-up and go test	Baseline, after 7, 14, 26 and 38 weeks
Secondary	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
Secondary	Change in Flexibility	Evaluated using the sit and reach test (Wells Bench)	Baseline, after 7, 14, 26 and 38 weeks
Secondary	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
Secondary	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
Secondary	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