Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
| Status: | Completed |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | August 1, 2013 |
| End Date: | December 31, 2018 |
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.
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.
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 yoga intervention will consist of three treatment components: 1) in-person
group yoga taught by a certified yoga therapist; 2) a relaxation audio recording for
home-use; and 3) a DVD recording to reinforce concepts taught during in-person yoga sessions.
Patients randomized to the structured exercise program (SEP) arm will participate in a
12-week exercise program delivered in a group/class format and supervised by a fitness
instructor. In addition, SEP patients will receive a DVD (for home use) describing the
benefits of aerobic exercise for fibromyalgia, a one-on-one consultation session with the
fitness instructor, an individualized exercise prescription, and supervised exercise sessions
for 12 weeks.
one of two treatment arms. The YOGA arm will involve a standardized 12-week, yoga-based
intervention. The yoga intervention will consist of three treatment components: 1) in-person
group yoga taught by a certified yoga therapist; 2) a relaxation audio recording for
home-use; and 3) a DVD recording to reinforce concepts taught during in-person yoga sessions.
Patients randomized to the structured exercise program (SEP) arm will participate in a
12-week exercise program delivered in a group/class format and supervised by a fitness
instructor. In addition, SEP patients will receive a DVD (for home use) describing the
benefits of aerobic exercise for fibromyalgia, a one-on-one consultation session with the
fitness instructor, an individualized exercise prescription, and supervised exercise sessions
for 12 weeks.
Inclusion Criteria:
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 Criteria:
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
We found this trial at
1
site
Indianapolis, Indiana 46202
Principal Investigator: Matthew J. Bair, MD MS
Phone: 317-988-3838
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