Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial

Completed · Not applicable

Conditions studied: Fibromyalgia

In brief

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 that of a structured exercise program (SEP) for subjects with fibromyalgia. The study aims are: 1) to compare the interventions' (YOGA vs. SEP) effects on overall fibromyalgia severity at 1 month (early response), 3 months (immediate post-intervention) and at 6 and 9 months (sustained effects); 2) to compare the interventions effects on specific fibromyalgia symptoms (pain, sleep, and fatigue), functional impairment, and related outcomes (quality of life, psychological symptoms); and 3) to compare the cost-effectiveness of the interventions.

Key facts

Study ID

NCT01797263

Run by

VA Office of Research and Development

People needed

256

Starts

2013-08-01

Expected to finish

2018-12-31

Last updated by the study team

2020-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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