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| Name | Class |
|---|---|
| Richard L. Roudebush VA Medical Center | FED |
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This study evaluates the feasibility of a behavioral intervention designed to replace sedentary behavior with light physical activity in veterans with Fibromyalgia. The study will also evaluate the acceptability of the intervention among veterans and intervention effects on pain and physical function.
Recent research suggests that individuals with Fibromyalgia (FM) who spend more time in sedentary behavior and less time in light physical activity experience greater clinical pain and overall impact of FM, irrespective of time spent in moderate to vigorous physical activity. To date, no studies have investigated the potential impact of reducing sedentary behavior on key clinical and physical function outcomes in FM. The overall objective of the pilot project is to design and evaluate the feasibility of an 8-week behavioral intervention designed to replace sedentary behavior with light physical activity in veterans with FM. Mixed (quantitative and qualitative) methods will be used to evaluate the behavioral intervention, which is based on constructs from social cognitive and self-regulatory theories that consistently identify important drivers of behavior change as: education, goal-setting, self-monitoring and behavioral prompts to move via an activity tracker and phone app, and feedback on behavior via weekly meetings.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSeT-FM intervention | Behavioral | The ReSeT-FM intervention focuses on behavior changes strategies aimed at reducing sedentary time and includes: education, goal setting, self-monitoring of behavior and behavioral prompts to move via an activity tracker and phone app, and feedback on behavior via weekly meetings with study coaches. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in minutes of sedentary time per day | Participants will wear an Actigraph accelerometer, which provides a well established measure of sedentary time. | This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week. |
| Change in minutes of light physical activity per day. | Participants will wear an Actigraph accelerometer, which provides a well established measure of light physical activity. | This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire Revised (FIQ-R) | This 21-item instrument assesses symptoms, function, and overall impact of fibromyalgia. | This measure will be assessed at baseline and 8 weeks. |
| Brief Pain Inventory (BPI) |
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Inclusion Criteria:
Veterans will be eligible if they have:
Exclusion Criteria:
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Primary Care Clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Kelly M Naugle, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roudebush VA Medical Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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This 11-item instrument rates the intensity of pain as well as interference of pain with mood, physical activity, work, social activity, relations with others, sleep, and enjoyment of life.
| This measure will be assessed at baseline and 8 weeks. |
| Medical Outcomes Study Short Form Questionnaire (SF-12) | This questionnaire assess physical and mental functioning. | This measure will be assessed at baseline and 8 weeks. |
| Six minute walk test | This physical function test measures functional aerobic capacity. Subjects will walk as far as possible at their usual pace in 6 minutes around a predetermined indoor walking course on a flat surface. | This measure will be assessed at baseline and 8 weeks. |
| 30-second Chair stand test | This physical function test measures lower body muscle strength. Subjects will complete as many sit to stands in a chair as possible in 30 seconds. | This measure will be assessed at baseline and 8 weeks. |
| D009422 |
| Nervous System Diseases |