Back to resultsProgressive Resistance Training for Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Progressive resistance training program
Educational Program
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Pain, Function, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;
- Feminine gender;
- Age between 18 and 65 years;
- Pain between 3 and 8 cm in the Numerical Pain Scale (END);
- Have not changed treatment for fibromyalgia in the past three months;
- Agree to participate in the study and sign the informed consent form.
Exclusion Criteria:
- Cognitive deficit that does not allow the understanding of the evaluation instruments;
- Other diseases that make it impossible to perform the exercises;
- Physical activity started or changed in the last three months;
- Physical therapy in the last six months;
- In litigation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Change in pain
Measured by numerical pain scale
Secondary Outcome Measures
Change in Health related quality of life
Measured by Fibromyalgia Impact Questionnaire
Change in Generic quality of life
Measured by the Medical Outcome Survey Short Form 36
Change in Functional capacity
Measured by the 6-minute Walk Test
Change in strength
Measured by the 1 repetition maximum
Full Information
NCT ID
NCT03588208
First Posted
July 4, 2018
Last Updated
July 4, 2018
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03588208
Brief Title
Progressive Resistance Training for Fibromyalgia
Official Title
Evaluation of the Effectiveness of a Progressive Resistance Training Program for Patients With Fibromyalgia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
September 2, 2017 (Actual)
Study Completion Date
March 25, 2018 (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
Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks. Patients in the control group performed the same education program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Pain, Function, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Progressive resistance training program
Intervention Description
Progressive resistance training program were performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training.
Intervention Type
Other
Intervention Name(s)
Educational Program
Intervention Description
Structured education program were performed during one hour class once a week for five weeks
Primary Outcome Measure Information:
Title
Change in pain
Description
Measured by numerical pain scale
Time Frame
Baseline and after 6 and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Health related quality of life
Description
Measured by Fibromyalgia Impact Questionnaire
Time Frame
Baseline and after 6 and 12 weeks
Title
Change in Generic quality of life
Description
Measured by the Medical Outcome Survey Short Form 36
Time Frame
Baseline and after 6 and 12 weeks
Title
Change in Functional capacity
Description
Measured by the 6-minute Walk Test
Time Frame
Baseline and after 6 and 12 weeks
Title
Change in strength
Description
Measured by the 1 repetition maximum
Time Frame
Baseline and after 6 and 12 weeks
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;
Feminine gender;
Age between 18 and 65 years;
Pain between 3 and 8 cm in the Numerical Pain Scale (END);
Have not changed treatment for fibromyalgia in the past three months;
Agree to participate in the study and sign the informed consent form.
Exclusion Criteria:
Cognitive deficit that does not allow the understanding of the evaluation instruments;
Other diseases that make it impossible to perform the exercises;
Physical activity started or changed in the last three months;
Physical therapy in the last six months;
In litigation.
12. IPD Sharing Statement
Learn more about this trial
Progressive Resistance Training for Fibromyalgia
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