Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
结局指标
主要结局
Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
时间窗: 3 month
This measure will be assessed at Baseline, 1, 3, 6 and 9 months. The 3 month is the primary end point and the 6 and 9 month assessments are for sustained effect. Min:0, Max: 90. Higher Score = Worse Outcome.
次要结局
- SF-12 Mental Score (Health-related Quality of Life)(3 Month)
- Fibromyalgia Impact Questionnaire-Revised Impact Subscale(3 Month)
- Fibromyalgia Impact Questionnaire Revised Symptoms Subscale(3 Month)
- Brief Pain Inventory (BPI) Severity Subscale(3 month)
- GAD-7 Anxiety Scale(3 Month)
- PTSD Checklist of Symptoms(3 Month)
- SF-12 Physical Score (Health-related Quality of Life)(3 Month)
- MOS Sleep Scale - Problems Index(3 Month)
- Arthritis Self-efficacy Scale(3 Month)
- Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale(3 Month)
- Multi-dimensional Fatigue Inventory(3 Month)
- Pain Catastrophizing Scale(3 Month)
- PHQ-9 for Depression(3 Month)