Fibromyalgia Clinical Trial
Official title:
Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
Verified date | March 2017 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 207 |
Est. completion date | September 21, 2005 |
Est. primary completion date | September 21, 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Arthritis Foundation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibromyalgia Impact Questionnaire | Baseline, 16 wks and 10 months | ||
Secondary | SF36 subscales | Baseline, 16 wks and 10 months | ||
Secondary | Beck Depression Inventory | Baseline, 16 wks and 10 months | ||
Secondary | Beck Anxiety Inventory | Baseline, 16 wks and 10 months | ||
Secondary | 6 minute Walk Test | Baseline, 16 wks and 10 months | ||
Secondary | 1 Repetition Maximum Chest Press | Baseline, 16 wks and 10 months | ||
Secondary | 1 Repetition Maximum Leg Press | Baseline, 16 wks and 10 months | ||
Secondary | Self Efficacy Scale | Baseline, 16 wks and 10 months |
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