- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00321659
Optimizing Fibromyalgia Self-management
Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:
- cardiovascular and flexibility exercise
- strength training, cardiovascular and flexibility exercise
- Arthritis Foundation's Fibromyalgia Self-Help course
- a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women aged 25 to 75 years of age
- A confirmed diagnosis of FMS by a primary care physician (and rheumatologist if present) using the American College of Rheumatology criteria
- Currently under care for their FMS by a primary care physician or rheumatologist
- Determined to be medically stable by their primary care physician and capable of participation in a supervised program of low to moderate intensity exercise
- Willingness to commit to time and travel requirements of project
Exclusion Criteria:
- Do not fulfill ACR definition of FMS
- Presence of a concurrent condition that limits a person's ability to perform the exercise program (i.e., advanced RA or OA, recent MI)
- History of a positive exercise/stress test, or current cardiovascular, pulmonary, neurological, or renal disease where an exercise program is contraindicated
- Uncontrolled hypertension, diabetes, asthma, or heart failure
- Physician does not want his/her patient to participate for any reason
Study Plan
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: Aerobic and flexibility exercise
16 weeks of aerobic and flexibility exercise.
Three days per week for 1 hour of walking and cycling.
|
3x/week of walking and cycling
|
Experimental: Strength, aerobic, and flexibility
16 weeks of strength training, aerobic, and flexibility exercise (ST) intervention;
|
3x/week of resistance training activities
|
Experimental: Fibromyalgia Self-Help Course
7 weeks of FSHC behavior change education
|
Biweekly group education group meetings
Other Names:
|
Experimental: a Combination of ST and FSHC
16 wks of a combination of ST and FSHC (ST-FSHC) exercise and behavior change education
|
3x/week of aerobic and strength training activities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fibromyalgia Impact Questionnaire
Time Frame: Baseline, 16 wks and 10 months
|
Baseline, 16 wks and 10 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SF36 subscales
Time Frame: Baseline, 16 wks and 10 months
|
Baseline, 16 wks and 10 months
|
Beck Depression Inventory
Time Frame: Baseline, 16 wks and 10 months
|
Baseline, 16 wks and 10 months
|
Beck Anxiety Inventory
Time Frame: Baseline, 16 wks and 10 months
|
Baseline, 16 wks and 10 months
|
6 minute Walk Test
Time Frame: Baseline, 16 wks and 10 months
|
Baseline, 16 wks and 10 months
|
1 Repetition Maximum Chest Press
Time Frame: Baseline, 16 wks and 10 months
|
Baseline, 16 wks and 10 months
|
1 Repetition Maximum Leg Press
Time Frame: Baseline, 16 wks and 10 months
|
Baseline, 16 wks and 10 months
|
Self Efficacy Scale
Time Frame: Baseline, 16 wks and 10 months
|
Baseline, 16 wks and 10 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Daniel S. Rooks, PhD, Beth Israel Deaconess Medical Center
Publications and helpful links
General Publications
- Rooks DS, Silverman CB, Kantrowitz FG. The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. Arthritis Rheum. 2002 Feb;47(1):22-8. doi: 10.1002/art1.10180.
- Rooks DS, Gautam S, Romeling M, Cross ML, Stratigakis D, Evans B, Goldenberg DL, Iversen MD, Katz JN. Group exercise, education, and combination self-management in women with fibromyalgia: a randomized trial. Arch Intern Med. 2007 Nov 12;167(20):2192-200. doi: 10.1001/archinte.167.20.2192.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2001P001769
- K23AR048305 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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