Optimizing Fibromyalgia Self-management

NCT ID: NCT00321659

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-10
• Study Completion Date: 2005-09-21

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

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aerobic and flexibility exercise

16 weeks of aerobic and flexibility exercise. Three days per week for 1 hour of walking and cycling.

Group Type: EXPERIMENTAL

Aerobic

Intervention Type: BEHAVIORAL

3x/week of walking and cycling

Strength, aerobic, and flexibility

16 weeks of strength training, aerobic, and flexibility exercise (ST) intervention;

Group Type: EXPERIMENTAL

Strength training

Intervention Type: BEHAVIORAL

3x/week of resistance training activities

Fibromyalgia Self-Help Course

7 weeks of FSHC behavior change education

Group Type: EXPERIMENTAL

FSHC

Intervention Type: BEHAVIORAL

Biweekly group education group meetings

a Combination of ST and FSHC

16 wks of a combination of ST and FSHC (ST-FSHC) exercise and behavior change education

Group Type: EXPERIMENTAL

Combination

Intervention Type: BEHAVIORAL

3x/week of aerobic and strength training activities

Interventions

Aerobic

3x/week of walking and cycling

Intervention Type: BEHAVIORAL

Strength training

3x/week of resistance training activities

Intervention Type: BEHAVIORAL

Combination

3x/week of aerobic and strength training activities

Intervention Type: BEHAVIORAL

FSHC

Biweekly group education group meetings

Intervention Type: BEHAVIORAL

Other Intervention Names

Fibromyalgia Self-Help Course

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthritis Foundation

OTHER

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Daniel Rooks

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel S. Rooks, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

References

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.

Reference Type: BACKGROUND

PMID: 11932874 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17998491 (View on PubMed)

Other Identifiers

K23AR048305

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2001P001769

Identifier Type: -

Identifier Source: org_study_id