Ignite Creation Date:
2024-05-05 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00573612
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2007-12-12
Brief Title:
Exercise-based Motivational Interviewing for Fibromyalgia
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Exercise-based Motivational Interviewing for Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia FMS defined as the presence of both chronic widespread pain and the finding of 1118 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 eg chronic back pain
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR054324 | NIH | None | httpsreporternihgovquickSearchR01AR054324 |