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Completed Not applicable Interventional

Exercise-based Motivational Interviewing for Fibromyalgia

ClinicalTrials.gov ID: NCT00573612

Public ClinicalTrials.gov record NCT00573612. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00573612
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Indiana University
Other
Enrollment
200 participants

Conditions and interventions

Conditions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2007
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011
Last update posted
Apr 5, 2012

2007 – 2011

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institute of Fitness of Sports, IUPUI Campus Indianapolis Indiana 46202

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00573612, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 5, 2012 · Synced Sep 6, 2026

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