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NCT00573612 · ClinicalTrials.gov registry record · NA
Exercise-based Motivational Interviewing for Fibromyalgia
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT00573612 is a NA study that has completed, run by Indiana University. The registered enrollment target is 200 participants.
The verdict
NCT00573612, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Motivational Interviewing
- BEHAVIORAL Attention Control Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2007-12 |
| Est. Completion | 2011-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00573612
The ClinicalTrials.gov registry entry for NCT00573612 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Motivational Interviewing is the first listed.
NCT00573612 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00573612 about?
NCT00573612 is a clinical study titled "Exercise-based Motivational Interviewing for Fibromyalgia". 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...
What is the current status of trial NCT00573612?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2007-12. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00573612?
The interventions under investigation include: Motivational Interviewing (BEHAVIORAL), Attention Control Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT00573612?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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