Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial

VA Office of Research and Development

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Structured Exercise; Other: Yoga

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01797263

D1100-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

Yoga

Experimental group

Description:

A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. It will include low intensity, low impact modified poses adapted with pathophysiologic changes of fibromyalgia in mind. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.

Treatment:

Other: Yoga

Structured Exercise

Active Comparator group

Description:

A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.

Treatment:

Other: Structured Exercise