Clinical trial NCT03682588: A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia
Official title: A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Exercise
Functional training
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain
timeFrame: Baseline, after 7, 14, 26 and 38 weeks
Secondary outcomes:
measure: Change in Muscular Strength
timeFrame: Baseline, after 7, 14, 26 and 38 weeks
measure: Change in functional performance
timeFrame: Baseline, after 7, 14, 26 and 38 weeks
measure: Change in balance
timeFrame: Baseline, after 7, 14, 26 and 38 weeks
measure: Change in Flexibility
timeFrame: Baseline, after 7, 14, 26 and 38 weeks
measure: Change in General quality of life
timeFrame: Baseline, after 7, 14, 26 and 38 weeks
measure: Change in medications consumption
timeFrame: Baseline, after 7, 14, 26 and 38 weeks
measure: Change in health-related quality of life
timeFrame: Baseline, after 7, 14, 26 and 38 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Rheumatology outpatient clinics of a university hospital;
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Jamil Natour, Professor
role: STUDY_DIRECTOR
References: