Therapeutic Yoga to Improve Function in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change in Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale at 8 weeks
研究概览
简要总结
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.
详细描述
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study utilizing an after-trial embedded mixed methods approach that will examine the efficacy of therapeutic yoga as a rehabilitation strategy for individuals with PD to improve balance and reduce fear of falling (FoF). Potential participants will have a FoF in order to enter the study. An after-trial embedded mixed methods design will be employed in this study and will include the collection of qualitative data to assist in the overall interpretation of the more heavily weighted quantitative trial data. Adding qualitative methods will serve as a post-hoc analysis capturing participant perceptions of the relationships between the yoga intervention and various outcomes. More specifically, the qualitative data will aide in explaining the link between the various yoga techniques and mechanisms that participants attribute to improved balance, reduced FoF, and other bio-psychosocial outcomes and experiences. Qualitative data will be collected using focus group interviews with participants in the yoga group at the end of the class in week 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Diagnosis of Parkinson's Disease with a rating of 1.5-4 on the Modified Hoehn and Yahr Scale of Parkinson's Disease Progression
- •Endorsement of FoF,44 able to stand and walk 10 meters with or without an assistive device
- •>18 years old; able to speak English
- •Score >4 out of 6 on the short Mini Mental Status Exam
- •Able and willing to attend twice weekly sessions for 8 weeks
排除标准
- •People with self-reported life expectancy <12 months
- •Inability to attend sessions due to transportation issues
- •Current involvement with other physical activity (including yoga), rehabilitation, or other intervention studies
- •Inability or refusal to provide informed consent
研究组 & 干预措施
Experimental
The experimental group is the group that received yoga. The individuals originally assigned to the WLC who completed the yoga intervention AFTER the 8 weeks WLC period also are considered part of the experimental group.
干预措施: Therapeutic yoga for people with Parkinson's Disease (Other)
Wait List Control
There was no intervention during the WLC.
结局指标
主要结局
Change in Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale at 8 weeks
时间窗: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
A performance based assessment of motor function.
Change in Mini BESTest at 8 weeks
时间窗: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
clinical balance assessment tool that targets 4 balance control systems, including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait
Change in Functional Gait Assessment at 8 weeks
时间窗: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
assesses postural stability during 10 walking tasks
次要结局
- Change in Freezing of Gait Questionnaire at 8 weeks(baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period)
- Change in Parkinson's Fatigue Scale at 8 weeks(baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period)
- Change in Activity Balance Confidence Scale at 8 weeks(baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period)
- Change in Activity Constraints Scale at 8 weeks(baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period)
- Change in Parkinson's Disease Questionnaire (PDQ-8) at 8 weeks(baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period)