Reducing Sedentary Time in Fibromyalgia Patients



Status:Recruiting
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - 65
Updated:4/17/2018
Start Date:March 15, 2018
End Date:July 2019
Contact:Kelly M Naugle, PhD
Email:kmnaugle@iupui.edu
Phone:317-274-0601

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

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.

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
We found this trial at
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Indianapolis, Indiana 46202
Phone: 317-274-0601
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