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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

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE September 24, 2018
Last Update Posted Date September 28, 2018
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
Change in pain [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
Evaluated using the Visual Analogue Scale
Change History Complete list of historical versions of study NCT03682588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Change in Muscular Strength [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
    Evaluated using the one-repetition maximum test
  • Change in functional performance [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
    Evaluated using the Time-up and go test
  • 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.
  • Change in Flexibility [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
    Evaluated using the sit and reach test (Wells Bench)
  • 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..
  • 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
  • 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..
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
  • Change in Muscular Strength [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
    Evaluated using the one-repetition maximum test
  • Change in functional performance [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
    Evaluated using the Time-up and go test
  • Change in balance [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
    Evaluated using the Berg balance scale
  • Change in Flexibility [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
    Evaluated using the sit and reach test (Wells Bench)
  • Change in General quality of life [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
    Evaluated using the Short-form 36 questionnaire
  • 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
  • Change in health-related quality of life [ Time Frame: Baseline, after 7, 14, 26 and 38 weeks ]
    Evaluated using the Fibromyalgia Impact Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia
Official Title  ICMJE A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Fibromyalgia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Physical activity
  • 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
    Intervention: Other: Physical activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2018)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2019
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Giovana Fernandes +55 11 981341963 giovanafernandes.cp@gmail.com
Contact: Rheumatology Division Rheumatology Division +55 11 5539-0893
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03682588
Other Study ID Numbers  ICMJE 719.779
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giovana Fernandes, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jamil Natour, Professor Federal University of São Paulo
PRS Account Federal University of São Paulo
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP