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临床试验/NCT04215900
NCT04215900已完成不适用

The Impact of High-speed Yoga on Executive Function and Functional Ability in Individuals Diagnosed With Parkinson's Disease.

University of Miami2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change in Executive Function (EF)

研究概览

简要总结

The purpose of this research study is to establish if a novel high-speed yoga program which incorporates visual cues can make a positive change in the participant's ability to make decisions and move as measured by several cognitive, balance and functional tests. It has been shown that yoga can improve balance and movement in those diagnosed with Parkinson's disease.

详细描述

The purpose of this research study is to establish if a novel high-speed yoga program which incorporates visual cues can make a positive change in the participant's ability to make decisions and move as measured by several cognitive, balance and functional tests. It has been shown that yoga can improve balance and movement in those diagnosed with Parkinson's disease. Subjects will be randomly assigned to either the high-speed yoga group or an inactive control group. All subjects will be tested before and after the 16 week training period using tests of balance, cognition and functional movement. The high-speed yoga group will receive yoga sequences lead by a certified yoga instructor during each of the 32 visits to the yoga studio. Each session will last one hour and be conducted two times per week. The program will consist of several different balance poses and movements where participants are encouraged to move quickly. Participants will also be asked to move in different directions based on colored lines placed on the yoga mat. To ensure a safe environment, several assistants will be present to help participants move into each pose. In addition, several assistive devices such as chairs and yoga blocks will be available if participants chose to use them.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women between 50 and 85 years of age (inclusive);
  • Diagnosis of Parkinson's Disease (Hoehn and Yahr scale I-III);
  • Ability to ambulate with or without an assistive device for at least 50 ft;
  • Ability to get up and down from the floor with minimal assistance;
  • Ability to provide informed consent;
  • No medical contraindication to participation in an exercise program including unstable or active untreated major medical illness (i.e., cardiovascular disease, neurological or neuromuscular diseases, stroke, cancer, etc.);
  • A score of 23 or above on the Montreal Cognitive Assessment;
  • Not currently participating in yoga more than one time per week;
  • Can understand and communicate in English.
  • Willing and bale to provide consent.

排除标准

  • Existing musculoskeletal injury.
  • Severe freezing of gait.
  • Enrolled in another yoga or research program.
  • Unstable or active major medical illness.
  • Answer "Yes" to any questions on the PAR-Q or Elder PAR-Q.

结局指标

主要结局

Change in Executive Function (EF)

时间窗: Baseline, Week 20.

The Wisconsin Card Sort task evaluates executive function with correct scores and errors associated with previously used rules known as preservative errors. Scores (t-scores) on the Wisconsin Card Sort task (total error) at study endpoint adjusted for education are min=0 and max=100. Higher scores indicate better outcomes.

Change in Cognitive Dysfunction

时间窗: Baseline, Week 19

The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. A total possible score is 30 points with a range of 0-30. A score of 26 or above is considered normal.

Change in Executive Function as Measured by Changes in Visual Spatial Ability and Task-switching

时间窗: Baseline, Week 20

The Trail Making Test Part A \& B measures visuospatial abilities, working memory and task switching abilities associated with EF domains. Lower times to completion and fewer errors indicate better performance. Scores for Part A typically can range from 20 to 90 seconds. Scores for Part B can range from 60 seconds to 180 seconds.

Change in Distance Walked in Six Minutes

时间窗: Baseline, Week 19

The six-minute walk test measures cardiovascular performance. The test measures how far you can walk in 6 minutes. Scores typically range from 200 to 500 meters in Parkinson's disease (PD) patients.

Change in Executive Function Measured by Inhibition of Cognitive Inference

时间窗: Baseline, Week 20

The Stroop color word test evaluates the participant's ability to inhibit cognitive inference. This is a cognitive domain of executive function and involves the processing of a stimulus where one feature of a previous stimulus may affect the simultaneous processing of a new stimulus. The total score can range from 0 to 100 with higher scores indicating better memory function.

次要结局

  • Changes in Reactive Balance Time(Baseline, Week 19)
  • Changes in Perceived Fall Risk(Baseline, Week 19)
  • Changes in Motor Function(Baseline, Week 19)
  • Changes in body weight(Baseline, Week 19)
  • Changes in Functional Agility(Baseline, Week 19)
  • Changes in fat-free mass(Baseline, Week 19)
  • Changes in Dynamic Balance(Baseline, Week 19)
  • Changes in Quality of Life(Baseline, Week 19)
  • Changes in Reactive Balance Distance(Baseline, Week 19)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Signorile

Professor

University of Miami

研究点 (2)

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