Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial (POYSE)
2020年2月10日 更新者：VA Office of Research and Development
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
256
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Yoga
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.
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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.
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有源比较器：Structured Exercise
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.
|
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
大体时间：3 month
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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.
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3 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale
大体时间：3 Month
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This represents a subscale of the FIQr and measures patient perceived difficulty related to fibromyalgia.
Min:0, Max: 20.
Higher Score = Worse Outcome.
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3 Month
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Fibromyalgia Impact Questionnaire-Revised Impact Subscale
大体时间：3 Month
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This is a subscale of the FIQr and measures the overall impact of fibromyalgia symptoms.
Min:0, Max: 100.
Higher Score = Worse Outcome.
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3 Month
|
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Fibromyalgia Impact Questionnaire Revised Symptoms Subscale
大体时间：3 Month
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This subscale of the FIQr provides an overall fibromyalgia symptom score.
Min:0, Max: 100.
Higher Score = Worse Outcome
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3 Month
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Brief Pain Inventory (BPI) Severity Subscale
大体时间：3 month
|
is an 11-item, multidimensional pain measurement tool with demonstrated reliability in patients with arthritis as well as other pain conditions.
The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations with others, sleep, and enjoyment of life.Min:0, Max: 40.
Higher Score = Worse Outcome.
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3 month
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PHQ-9 for Depression
大体时间：3 Month
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will be used to assess depression severity.
Several studies have validated the PHQ-9 as a diagnostic measure with excellent psychometric properties.
Internal consistency has consistently been shown to be high (Cronbach's alpha > 0.80) and test-retest assessment showed the PHQ-9 to be a responsive and reliable measure of depression treatment outcomes.
Min:0, Max: 27.
Higher Score = Worse Outcome.
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3 Month
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GAD-7 Anxiety Scale
大体时间：3 Month
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This 7-item scale represent a measure of anxiety symptom severity and provides a score from 0 to 21 with higher scores representing more severe anxiety
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3 Month
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PTSD Checklist of Symptoms
大体时间：3 Month
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This 17-item scale assess PTSD symptom severity and provides a severity score; with higher scores representing more severe PTSD.
Min: 0, Max: 85 with higher scores representing more severity.
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3 Month
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SF-12 Physical Score (Health-related Quality of Life)
大体时间：3 Month
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The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score.
Min:0, Max: 100.
Higher Score = Worse Outcome.
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3 Month
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SF-12 Mental Score (Health-related Quality of Life)
大体时间：3 Month
|
The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score.
Min:0, Max: 100.
Higher Score = Worse Outcome.
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3 Month
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Multi-dimensional Fatigue Inventory
大体时间：3 Month
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This scale assesses overall fatigue and has been well-validated and used in other fibromyalgia trials.
Min:0, Max: 100.
Higher Score = Worse Outcome.
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3 Month
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MOS Sleep Scale - Problems Index
大体时间：3 Month
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This scale assesses different aspects of sleep quality and provides an overall index with higher scores representing more severe sleep problems.
Min:0, Max: 100.
Higher Score = Worse Outcome.
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3 Month
|
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Pain Catastrophizing Scale
大体时间：3 Month
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This 13-item scale assesses pain catastrophizing which has been found to be a predictor of poor treatment response.
Min: 0. Max: 52.
Higher Score = Worse Outcome.
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3 Month
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Arthritis Self-efficacy Scale
大体时间：3 Month
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This scale has been well-validated to assess self-efficacy or confidence in a person's ability to complete a task.
Min: 0, Max: 60.
Higher score represents improvement.
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3 Month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年8月1日
初级完成 (实际的)
2018年7月2日
研究完成 (实际的)
2018年12月31日
研究注册日期
首次提交
2013年2月20日
首先提交符合 QC 标准的
2013年2月20日
首次发布 (估计)
2013年2月22日
研究记录更新
最后更新发布 (实际的)
2020年2月24日
上次提交的符合 QC 标准的更新
2020年2月10日
最后验证
2020年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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