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

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ClinicalTrials.gov Identifier: NCT03682588
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Giovana Fernandes, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Physical activity Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Randomised electronically generated randomisation table. Secret allocation (sealed opaque envelopes).
Primary Purpose: Treatment
Official Title: A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia: A Randomized Controlled Trial
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 1, 2018
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Functional exercise group and Stretching exercise group




Primary Outcome Measures :
  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 Outcome Measures :
  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..



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682588


Contacts
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Contact: Giovana Fernandes +55 11 981341963 giovanafernandes.cp@gmail.com
Contact: Rheumatology Division Rheumatology Division +55 11 5539-0893

Locations
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Brazil
Rheumatology outpatient clinics of a university hospital; Recruiting
São Paulo, SP, Brazil, CEP 04039-002
Contact: Giovana Fernandes       giovanafernandes.cp@gmail.com   
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Study Director: Jamil Natour, Professor Federal University of São Paulo

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Responsible Party: Giovana Fernandes, PhD Student, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03682588     History of Changes
Other Study ID Numbers: 719.779
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giovana Fernandes, Federal University of São Paulo:
Fibromyalgia
Treatment
Exercise

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases