Working… Menu

Optimizing Fibromyalgia Self-management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00321659
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : March 14, 2017
Arthritis Foundation
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Daniel Rooks, Beth Israel Deaconess Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Aerobic Behavioral: Strength training Behavioral: Combination Behavioral: FSHC Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
Actual Study Start Date : October 10, 2002
Actual Primary Completion Date : September 21, 2005
Actual Study Completion Date : September 21, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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.
Behavioral: Aerobic
3x/week of walking and cycling

Experimental: Strength, aerobic, and flexibility
16 weeks of strength training, aerobic, and flexibility exercise (ST) intervention;
Behavioral: Strength training
3x/week of resistance training activities

Experimental: Fibromyalgia Self-Help Course
7 weeks of FSHC behavior change education
Behavioral: FSHC
Biweekly group education group meetings
Other Name: Fibromyalgia Self-Help Course

Experimental: a Combination of ST and FSHC
16 wks of a combination of ST and FSHC (ST-FSHC) exercise and behavior change education
Behavioral: Combination
3x/week of aerobic and strength training activities

Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 16 wks and 10 months ]

Secondary Outcome Measures :
  1. SF36 subscales [ Time Frame: Baseline, 16 wks and 10 months ]
  2. Beck Depression Inventory [ Time Frame: Baseline, 16 wks and 10 months ]
  3. Beck Anxiety Inventory [ Time Frame: Baseline, 16 wks and 10 months ]
  4. 6 minute Walk Test [ Time Frame: Baseline, 16 wks and 10 months ]
  5. 1 Repetition Maximum Chest Press [ Time Frame: Baseline, 16 wks and 10 months ]
  6. 1 Repetition Maximum Leg Press [ Time Frame: Baseline, 16 wks and 10 months ]
  7. Self Efficacy Scale [ Time Frame: Baseline, 16 wks and 10 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00321659

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Arthritis Foundation
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Layout table for investigator information
Principal Investigator: Daniel S. Rooks, PhD Beth Israel Deaconess Medical Center
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Daniel Rooks, Principal Investigator, Beth Israel Deaconess Medical Center Identifier: NCT00321659    
Other Study ID Numbers: 2001P001769
K23AR048305 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2006    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan was prepared, as no data was to be shared.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Rooks, Beth Israel Deaconess Medical Center:
patient education
Additional relevant MeSH terms:
Layout table for MeSH terms
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases