Clinical trial NCT01797263: Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
Official title: Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
yoga
exercise
pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-02-22
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
timeFrame: 3 month
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale
timeFrame: 3 Month
measure: Fibromyalgia Impact Questionnaire-Revised Impact Subscale
timeFrame: 3 Month
measure: Fibromyalgia Impact Questionnaire Revised Symptoms Subscale
timeFrame: 3 Month
measure: Brief Pain Inventory (BPI) Severity Subscale
timeFrame: 3 month
measure: PHQ-9 for Depression
timeFrame: 3 Month
measure: GAD-7 Anxiety Scale
timeFrame: 3 Month
measure: PTSD Checklist of Symptoms
timeFrame: 3 Month
measure: SF-12 Physical Score (Health-related Quality of Life)
timeFrame: 3 Month
measure: SF-12 Mental Score (Health-related Quality of Life)
timeFrame: 3 Month
measure: Multi-dimensional Fatigue Inventory
timeFrame: 3 Month
measure: MOS Sleep Scale - Problems Index
timeFrame: 3 Month
measure: Pain Catastrophizing Scale
timeFrame: 3 Month
measure: Arthritis Self-efficacy Scale
timeFrame: 3 Month
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Matthew J. Bair, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allsop VL, Schmid AA, Miller KK, Slaven JE, Daggy JK, Froman A, Kline M, Sargent C, French DD, Ang D, Van Puymbroeck M, Schalk NL, Bair MJ. The Pain Outcomes Comparing Yoga vs. Structured Exercise (POYSE) Trial in Veterans With Fibromyalgia: Study Design and Methods. Front Pain Res (Lausanne). 2022 Jul 7;3:934689. doi: 10.3389/fpain.2022.934689. eCollection 2022.