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Sponsored by: |
Indiana University |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00573612 |
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 program, of adequate intensity, in order to maximize functioning and well-being for patients with FMS. The use of a predominantly home-based exercise program and telephone-delivered MI by a trained licensed practice nurse (LPN) could potentially make the proposed intervention more accessible to the greater majority of FMS patients. Furthermore, if proven efficacious, MI could readily be applied to other chronically painful conditions (e.g. chronic back pain).
Condition | Intervention |
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Fibromyalgia |
Behavioral: Attention Control Counseling Behavioral: Motivational Interviewing |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Exercise-Based Motivational Interviewing for Fibromyalgia |
Estimated Enrollment: | 200 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Telephone Call for the Attention Control Group Each AC call will follow the same format as the MI call. During the AC call, study subjects will receive health information on important topics relevant to their illness. Specifically, there will be one topic during each phone call that includes the following: (a) overview of FMS, (b) pain, (c) fatigue (d) sleep, (e) stress, and (f) living well with FMS. The AC calls will be an avenue to transfer relevant health information from the RA to the study subject. The scheduled topics during each contact will give the call face validity (i.e., establish a credible pretense for the contact) while being neutral with respect to encouragement of exercise.
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Behavioral: Attention Control Counseling
Subjects will receive educational-based telephone counseling regarding fibromyalgia.
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2: Active Comparator
Telephone-delivered Motivational Interviewing Participants will receive 6 telephone calls throughout the study. Harland et al reported that the most effective intervention for promoting exercise in the primary care setting was the most intensive treatment arm that included six MI sessions (208). Importantly, in our pilot study, participants who completed 5 to 6 phone calls achieved greater symptomatic benefits than participants who had ≤ 4 phone calls. The phone calls will be scheduled at week 3, 4, 6, 8, 10 and 12 of the study. Telephone sessions may run for 30 minutes on the average
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Behavioral: Motivational Interviewing
Subjects will receive Motivational Interviewing telephone counseling.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Janna K Hilligoss, LPN, CCRC | 317-278-3971 | fibrofit@iupui.edu |
Contact: Amelia Lengerich, BA | 317-274-0670 | mlengeri@iupui.edu |
United States, Indiana | |
National Institute of Fitness of Sports, IUPUI Campus | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: Dennis C Ang, MD |
Principal Investigator: | Dennis C. Ang, MD | Indiana University |
Responsible Party: | Indiana University ( Dr. Dennis Ang ) |
Study ID Numbers: | IRB 0708-62, RO1 AR054324 |
Study First Received: | December 12, 2007 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00573612 |
Health Authority: | United States: Institutional Review Board |
Fibromyalgia Fibromyalgia patients |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
Nervous System Diseases |