Optimizing Fibromyalgia Self-Management

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Arthritis Foundation
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00321659
First received: May 3, 2006
Last updated: September 29, 2006
Last verified: September 2006
  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:

  • 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

Condition Intervention
Fibromyalgia
Behavioral: exercise and behavior change education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Short and Long-Term Effects of Exercise and Education as Self-Management in Women With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire
  • SF36 Physical Function Scale

Secondary Outcome Measures:
  • SF36 subscales
  • Beck Depression Inventory
  • Beck Anxiety Inventory
  • 6 minute Walk Test
  • 1 Repetition Maximum Chest Press
  • 1 Repetition Maximum Leg Press
  • Self Efficacy Scale

Estimated Enrollment: 200
Study Start Date: October 2002
Estimated Study Completion Date: August 2006
Detailed Description:

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321659

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Arthritis Foundation
Investigators
Principal Investigator: Daniel S. Rooks, PhD Beth Israel Deaconess Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00321659     History of Changes
Other Study ID Numbers: K23 AR048305
Study First Received: May 3, 2006
Last Updated: September 29, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
fibromyalgia
self-management
exercise
patient education

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014