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| Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center Arthritis Foundation National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|---|---|
| Information provided by: | Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00321659 |
Purpose
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:
| Condition | Intervention |
|---|---|
|
Fibromyalgia |
Behavioral: exercise and behavior change education |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Short and Long-Term Effects of Exercise and Education as Self-Management in Women With Fibromyalgia |
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | August 2006 |
Fibromyalgia syndrome (FMS) is a common, chronic musculoskeletal disorder and a growing cause of disability and increased health care utilization.
Current treatment focuses largely on pharmacological interventions, which are often ineffective at improving symptoms and functional status. Recent research suggests that disease self-management can be efficacious in the short-term at reducing symptom severity and improving function in persons with FMS. The most common forms of FMS self-management are coping skills training (behavioral/education) and exercise. Limited in number, most FMS self-management studies examine the short-term effects of one form or the other, with most using the coping skills training approach. Little data exist to examine the long-term effects of these interventions, the potential additive effect of combining coping skills training with a comprehensive, group exercise program or an approach for promoting long-term compliance of these interventions. The objective of this proposal is to identify the optimal approach to FMS self-management. The study is a randomized, controlled trial comparing coping skills training (the Arthritis Foundation Fibromyalgia Self-Help Course (FSHC)) with two exercise programs - cardiovascular and flexibility training with and without strength training - and a combination (the FSHC plus the strength training exercise program). Each intervention period will last 16 weeks and include group sessions led by trained personnel.
Subjects will be followed for 6 months after completing the intervention to evaluate the short-term effect of each program. At 6 months, subjects will be randomized into two groups—one group will receive a 4 week refresher course of their original intervention every 6 months and the other group will receive no further intervention. Long-term follow up will be for 24 months after completing the 16 week intervention period. Subjects will include 200 women (four groups of 50), 25 to 65 years old with a confirmed diagnosis of FMS. Participants will undergo blinded assessment at the Beth Israel Deaconess Medical Center’s GCRC at five time points—baseline, completion of the 16-week intervention and 6, 12 and 24 month follow up. We will assess health and functional status (FIQ, SF36), symptom severity (FIQ, SF36, Beck scales), self-efficacy (Arthritis Self-Efficacy Scale), fitness (muscle strength, cardiovascular fitness, flexibility) and health care utilization (direct and indirect costs). The study will improve treatment outcomes for persons with FMS by identifying the optimal self-management program.
Eligibility| Ages Eligible for Study: | 25 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | K23 AR048305 |
| Study First Received: | May 3, 2006 |
| Last Updated: | September 29, 2006 |
| ClinicalTrials.gov Identifier: | NCT00321659 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
fibromyalgia self-management exercise patient education |
|
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
|
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Nervous System Diseases Rheumatic Diseases |