Back to resultsExercise for Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strength training
Aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Exercise, Pain
Eligibility Criteria
Inclusion Criteria:
- Established diagnosis of fibromyalgia, age > 18 years. Exclusion Criteria: cardiac, pulmonary or orthopedic condition that would limit exercise.
-
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Strength training
Aerobic exercise
Arm Description
Supervised strength training.
Supervised aerobic exercise.
Outcomes
Primary Outcome Measures
Pain severity
Validated measure of clinical pain.
Secondary Outcome Measures
Muscle strength
Assessment of muscle strength using a dynometer.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01253395
Brief Title
Exercise for Fibromyalgia
Official Title
Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Exercise, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strength training
Arm Type
Experimental
Arm Description
Supervised strength training.
Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Description
Supervised aerobic exercise.
Intervention Type
Behavioral
Intervention Name(s)
Strength training
Intervention Description
Daily supervised strength training.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
Daily supervised aerobic exercise.
Primary Outcome Measure Information:
Title
Pain severity
Description
Validated measure of clinical pain.
Time Frame
Week 3
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Assessment of muscle strength using a dynometer.
Time Frame
Week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
- Established diagnosis of fibromyalgia, age > 18 years. Exclusion Criteria: cardiac, pulmonary or orthopedic condition that would limit exercise.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William M Hooten, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23565175
Citation
Hooten WM, Rosenberg CJ, Eldrige JS, Qu W. Knee extensor strength is associated with pressure pain thresholds in adults with fibromyalgia. PLoS One. 2013;8(4):e59930. doi: 10.1371/journal.pone.0059930. Epub 2013 Apr 2.
Results Reference
derived
PubMed Identifier
22341565
Citation
Hooten MW, Qu W, Townsend CO, Judd JW. Effects of strength vs aerobic exercise on pain severity in adults with fibromyalgia: a randomized equivalence trial. Pain. 2012 Apr;153(4):915-923. doi: 10.1016/j.pain.2012.01.020. Epub 2012 Feb 15.
Results Reference
derived
Learn more about this trial
Exercise for Fibromyalgia
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