Clinical Trial: Exercise-based Motivational Interviewing for Fibromyalgia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Exercise-based Motivational Interviewing for Fibromyalgia
Brief Summary: Fibromyalgia (FMS), defined as the presence of both chronic widespread pain and the finding of 11/18 tender points on examination, affects 2% of the general population. Drug therapy for FMS is largely symptomatic as there is not yet a complete understanding of the pathogenesis of the disease. In the past 17 years, supervised aerobic exercise has emerged as an important treatment modality to improve pain, aerobic capacity, function, and well-being. Individuals who are able to adhere to exercise almost always maintain the symptomatic benefits of exercise. Unfortunately, the rate of exercise adherence six months after the completion of a well-structured supervised exercise program is disappointingly low. Furthermore, although the efficacy of supervised aerobic exercise in the research setting is well documented, the applicability of such intervention in the clinic setting is doubtful. Therefore, we propose to conduct the Research to Encourage Exercise for Fibromyalgia (REEF), a randomized attention-controlled trial whose primary aim is to evaluate the efficacy of telephone-delivered motivational interviewing (MI) to encourage exercise, in improving exercise adherence and self-report physical function (co-primary outcome measures) for FMS patients. REEF will enroll 200 FMS patients, randomizing them to either the MI group or the attention-control (AC) group. Participants from each group will receive a total of 6 telephone calls within a 12-week period. Prior to the phone calls, participants from both groups will receive an individualized exercise prescription and 2 supervised exercise training sessions to get them started on an exercise program. All subjects will undergo comprehensive outcome assessment at baseline, week 12, week 24, and week 36. The secondary aim of this proposal is to determine the mediators between MI and improvement in self-report physical function. The proposed research is significant because our focus is the promotion of adherence to an exercise p
Detailed Summary:
Sponsor: Indiana University
Current Primary Outcome: Measure the effects of exercise-based MI intervention improving exercise adherence. [ Time Frame: This is a five year study, each subject will participate in a 9-month study sequence ]
Original Primary Outcome: 1. Measure the effects of exercise-based MI intervention improving exercise adherence. 2. Evaluate the effects of exercise-based MI intervention in pain severity. 3. Determine between exercise-based MI intervention and the adherence. [ Time Frame: This is a five year study, each subject will participate in a 9-month study sequence ]
Current Secondary Outcome: To evaluate the effects of exercise-based MI intervention in pain severity and to determine between exercise-based MI intervention and the adherence. [ Time Frame: This is a five year study, each subject will participate in a 9-month study sequence ]
Original Secondary Outcome:
Information By: Indiana University
Dates:
Date Received: December 12, 2007
Date Started: December 2007
Date Completion:
Last Updated: April 5, 2012
Last Verified: March 2011
