Status:
COMPLETED
Reducing Sedentary Time in Fibromyalgia Patients
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Richard L. Roudebush VA Medical Center
Conditions:
Fibromyalgia
Veterans
Eligibility:
All Genders
18-65 years
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 ac...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03247348
Start Date
March 15 2018
End Date
September 9 2019
Last Update
February 11 2020
Active Locations (1)
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1
Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202