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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Exercise, Functional training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rheumatology outpatient clinics of a university hospital;

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Functional exercise group

Stretching exercise group

Arm Description

Functional exercise program with 14 exercises, two times/week, during 14 weeks. Two sets of 10 repetitions each, with 30 seconds interval.

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

Outcomes

Primary Outcome Measures

Change in pain
Evaluated using the Visual Analogue Scale for pain. Scores ranges from 0 to 10 with higher values represent a worse pain.

Secondary Outcome Measures

Change in Muscular Strength
Evaluated using the one-repetition maximum test
Change in functional performance
Evaluated using the Time-up and go test
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.
Change in Flexibility
Evaluated using the sit and reach test (Wells Bench)
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..
Change in medications consumption
Evaluated the amount of acetominophen (500mg de 6/6 hours) used for pain
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..

Full Information

First Posted
August 3, 2018
Last Updated
September 26, 2023
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03682588
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Exercise, Functional training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Randomised electronically generated randomisation table. Secret allocation (sealed opaque envelopes).
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional exercise group
Arm Type
Experimental
Arm Description
Functional exercise program with 14 exercises, two times/week, during 14 weeks. Two sets of 10 repetitions each, with 30 seconds interval.
Arm Title
Stretching exercise group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Physical activity
Other Intervention Name(s)
Functional exercise group and Stretching exercise group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain
Description
Evaluated using the Visual Analogue Scale for pain. Scores ranges from 0 to 10 with higher values represent a worse pain.
Time Frame
Baseline, after 7, 14, 26 and 38 weeks
Secondary Outcome Measure Information:
Title
Change in Muscular Strength
Description
Evaluated using the one-repetition maximum test
Time Frame
Baseline, after 7, 14, 26 and 38 weeks
Title
Change in functional performance
Description
Evaluated using the Time-up and go test
Time Frame
Baseline, after 7, 14, 26 and 38 weeks
Title
Change in balance
Description
Evaluated using the Berg balance scale to evaluate balance. Scores ranges from 0 to 56 with higher values represent a worse balance.
Time Frame
Baseline, after 7, 14, 26 and 38 weeks
Title
Change in Flexibility
Description
Evaluated using the sit and reach test (Wells Bench)
Time Frame
Baseline, after 7, 14, 26 and 38 weeks
Title
Change in General quality of life
Description
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..
Time Frame
Baseline, after 7, 14, 26 and 38 weeks
Title
Change in medications consumption
Description
Evaluated the amount of acetominophen (500mg de 6/6 hours) used for pain
Time Frame
Baseline, after 7, 14, 26 and 38 weeks
Title
Change in health-related quality of life
Description
Evaluated using the Fibromyalgia Impact Questionnaire. Scores ranges from 0 to 100 with higher values represent a worse quality of life..
Time Frame
Baseline, after 7, 14, 26 and 38 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamil Natour, Professor
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology outpatient clinics of a university hospital;
City
São Paulo
State/Province
SP
ZIP/Postal Code
CEP 04039-002
Country
Brazil

12. IPD Sharing Statement

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

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