Status:
COMPLETED
Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
Lead Sponsor:
VA Office of Research and Development
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Pain Outcomes comparing Yoga versus Structured Exercise (POYSE) Trial is a 2-arm parallel group, randomized clinical trial to compare the effectiveness of a yoga-based intervention (YOGA) with tha...
Detailed Description
This study sample will include 306 Veterans with fibromyalgia. Patients will be randomized to one of two treatment arms. The YOGA arm will involve a standardized 12-week, yoga-based intervention. The ...
Eligibility Criteria
Inclusion
- Veterans will be eligible if they have:
- 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
- Access to a working telephone
Exclusion
- Exclusion criteria includes:
- Severe medical conditions in which exercise is contraindicated (such as significant cardiovascular disease, COPD or asthma needing home oxygen, stroke or TIA in last 6 months, cancer (other than skin cancer) and receiving treatment for it
- Active psychosis
- Hospitalized for psychiatric reasons within the last 6 months
- Active suicidal ideation
- Moderate to severe cognitive impairment
- Involvement in ongoing yoga classes or moderately intense exercise program in the last 3 months
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT01797263
Start Date
August 1 2013
End Date
December 31 2018
Last Update
February 24 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884