Reducing Sedentary Time in Fibromyalgia Patients

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Change in minutes of sedentary time per day	This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.	Participants will wear an Actigraph accelerometer, which provides a well established measure of sedentary time.
Change in minutes of light physical activity per day.	This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.	Participants will wear an Actigraph accelerometer, which provides a well established measure of light physical activity.

Secondary Outcome Measures

Name	Time	Method
30-second Chair stand test	This measure will be assessed at baseline and 8 weeks.	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.
Fibromyalgia Impact Questionnaire Revised (FIQ-R)	This measure will be assessed at baseline and 8 weeks.	This 21-item instrument assesses symptoms, function, and overall impact of fibromyalgia.
Brief Pain Inventory (BPI)	This measure will be assessed at baseline and 8 weeks.	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.
Medical Outcomes Study Short Form Questionnaire (SF-12)	This measure will be assessed at baseline and 8 weeks.	This questionnaire assess physical and mental functioning.
Six minute walk test	This measure will be assessed at baseline and 8 weeks.	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.

Locations (1): Roudebush VA Medical Center
🇺🇸
Indianapolis, Indiana, United States