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Exercise-based Motivational Interviewing for Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00573612
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : April 6, 2012
Information provided by:
Indiana University

Tracking Information
First Submitted Date  ICMJE December 12, 2007
First Posted Date  ICMJE December 14, 2007
Last Update Posted Date April 6, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
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 Measures  ICMJE
 (submitted: December 13, 2007)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
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 Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Exercise-based Motivational Interviewing for Fibromyalgia
Official Title  ICMJE 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 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Behavioral: Attention Control Counseling
    Subjects will receive educational-based telephone counseling regarding fibromyalgia.
  • Behavioral: Motivational Interviewing
    Subjects will receive Motivational Interviewing telephone counseling.
Study Arms  ICMJE
  • Placebo Comparator: 1
    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.
    Intervention: Behavioral: Attention Control Counseling
  • Active Comparator: 2
    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
    Intervention: Behavioral: Motivational Interviewing
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 13, 2007)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. American College of Rheumatology (ACR) classification criteria for FMS(203)
  2. Has been on stable doses of FMS medications (i.e., cyclobenzaprine, tramadol, gabapentin, pregabalin, venlafaxine, duloxetine, pramipexole, tricyclic anti-depressant, selective serotonin reuptake inhibitor) for at least 4 weeks and willing to limit the introduction of new medications for FMS symptoms
  3. Age between 18-65 years old. Because the prevalence of sub-clinical coronary artery disease increases with older age, we are excluding those who are ≥ 66 years old

Exclusion Criteria:

  1. FIQ-PI score < 2
  2. BPI-PS <4
  3. Known cardiovascular disease, including congestive heart failure; previous episodes of angina pectoris; previous myocardial infarction; or previous revascularization procedure
  4. Moderate-severe chronic obstructive pulmonary disease, including asthma
  5. Uncontrolled hypertension
  6. Orthopedic or musculoskeletal conditions that would prohibit moderate-intensity exercise
  7. Active suicidal ideation
  8. Planned elective surgery during the study period
  9. Ongoing unresolved disability claims
  10. Other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease)
  11. Use of medications that may affect chronotropic response to exercise, i.e. beta-blocker or calcium channel blocker
  12. Pregnancy
  13. Schizophrenia or other psychosis
  14. Exercising 3 days a week or more. The US Surgeon General considers a physically active person as somebody who does at least 3 times a week of moderate to vigorous level of exercise(204). Thus, we are excluding the already physically active individuals from the study. In the pilot study, only 4% (2 out of 50) of the potential participants were excluded due to being physically active.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00573612
Other Study ID Numbers  ICMJE IRB 0708-62
R01AR054324 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Dennis Ang, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis C. Ang, MD Indiana University
PRS Account Indiana University
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP