- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01253395
Exercise for Fibromyalgia
December 2, 2010 updated by: Mayo Clinic
Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia
Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Established diagnosis of fibromyalgia, age > 18 years. Exclusion Criteria: cardiac, pulmonary or orthopedic condition that would limit exercise.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Strength training
Supervised strength training.
|
Daily supervised strength training.
|
|
Active Comparator: Aerobic exercise
Supervised aerobic exercise.
|
Daily supervised aerobic exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain severity
Time Frame: Week 3
|
Validated measure of clinical pain.
|
Week 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle strength
Time Frame: Week 3
|
Assessment of muscle strength using a dynometer.
|
Week 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William M Hooten, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
December 1, 2010
First Submitted That Met QC Criteria
December 2, 2010
First Posted (Estimate)
December 3, 2010
Study Record Updates
Last Update Posted (Estimate)
December 3, 2010
Last Update Submitted That Met QC Criteria
December 2, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 005-4167
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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