Reducing Sedentary Time in Fibromyalgia Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reducing Sedentary Time in Fibromyalgia (ReSeT-FM): A Feasibility Study

Conditions
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Fibromyalgia, Veterans

Intervention / Treatment
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* Behavioral: ReSeT-FM intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans will be eligible if they have: 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia: Widespread Pain Index (WPI) greater than 7 and Symptom Severity Scale (SS) greater than 5 or WPI 3-6 and SS greater than 9. Symptoms have been present at a similar level for at least 3 months The subject does not have a disorder that would otherwise explain the pain Moderate pain severity (pain severity score greater than 5) No changes in fibromyalgia medications for last 4 weeks Self-reporting at least 8 hours per day sitting on 5 or more days per week Having access to either an Android or iPhone smart phone with access to internet Exclusion Criteria: Significant cardiovascular disease chronic obstructive pulmonary disease (COPD) or asthma needing home oxygen Stroke or transient ischemic attack (TIA) in last 6 months Cancer (other than skin cancer) and receiving treatment for it Active psychosis Active suicidal ideation Moderate to severe cognitive impairment Engaging in more than 30 minutes of moderate to vigorous physical activity 3 or more days per week Currently using an app or activity tracker to track physical activity Enrolled in another research study related to pain or exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: ReSeT-FM intervention|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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. |