Optimizing Fibromyalgia Self-management
Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
2 other identifiers
interventional
207
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2002
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2005
CompletedFirst Submitted
Initial submission to the registry
May 3, 2006
CompletedFirst Posted
Study publicly available on registry
May 4, 2006
CompletedMarch 14, 2017
March 1, 2017
3 years
May 3, 2006
March 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fibromyalgia Impact Questionnaire
Baseline, 16 wks and 10 months
Secondary Outcomes (7)
SF36 subscales
Baseline, 16 wks and 10 months
Beck Depression Inventory
Baseline, 16 wks and 10 months
Beck Anxiety Inventory
Baseline, 16 wks and 10 months
6 minute Walk Test
Baseline, 16 wks and 10 months
1 Repetition Maximum Chest Press
Baseline, 16 wks and 10 months
- +2 more secondary outcomes
Study Arms (4)
Aerobic and flexibility exercise
EXPERIMENTAL16 weeks of aerobic and flexibility exercise. Three days per week for 1 hour of walking and cycling.
Strength, aerobic, and flexibility
EXPERIMENTAL16 weeks of strength training, aerobic, and flexibility exercise (ST) intervention;
Fibromyalgia Self-Help Course
EXPERIMENTAL7 weeks of FSHC behavior change education
a Combination of ST and FSHC
EXPERIMENTAL16 wks of a combination of ST and FSHC (ST-FSHC) exercise and behavior change education
Interventions
3x/week of resistance training activities
3x/week of aerobic and strength training activities
Biweekly group education group meetings
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 11932874BACKGROUNDRooks 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.
PMID: 17998491RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel S. Rooks, PhD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 3, 2006
First Posted
May 4, 2006
Study Start
October 10, 2002
Primary Completion
September 21, 2005
Study Completion
September 21, 2005
Last Updated
March 14, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share
No plan was prepared, as no data was to be shared.