Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi - a mind-body exercise - on motor and cognitive function as well as quality of life in individuals recently diagnosed with Parkinson's disease (PD).
详细描述
Specific Aim 1: To assess the feasibility of recruiting and retaining individuals with PD into a 6-month randomized controlled trial of Tai Chi exercise.
Specific Aim 2: To collect preliminary data on the efficacy of Tai Chi on improving gait and balance dynamics, physical and cognitive function, exercise activity, self-efficacy, mood, and quality of life in individuals with PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals recently diagnosed with idiopathic PD (≤ 10 years)
- •Limited disease progression
- •If taking PD-related medication, willingness to undergo baseline and follow-up testing while off medication
- •Willingness to commit to the study protocols and complete Tai Chi program
- •Willingness to be videotaped and audio-recorded during testing
排除标准
- •Diagnosis of any form of atypical parkinsonism
- •History of: stroke, head trauma, brain tumor, brain injury, seizures or other central nervous system condition, orthopedic impairment or other disease that could likely contribute to a gait disturbance or parkinsonism
- •Any severe, chronic condition or acute medical event for which participation in exercise programs is contraindicated (e.g. debilitating Rheumatoid Arthritis, history of frequent falls, unhealed fracture)**
- •** Unless the participant is able to obtain formal written approval from his/her treating physician granting permission to participate in our Tai Chi exercise program
- •Participation in brain stimulation within the past 3 months
- •Family history of seizures or unexplained loss of consciousness
- •Current history of dementia or severe psychiatric illness. Patients with mild (non-suicidal) depression and/or anxiety may be included
- •Acute illness requiring hospitalization within past 3 months
- •History of deep brain stimulation or other brain surgery
- •Participation in brain stimulation within the past 3 months
- •Regular use of walking aid
- •Significant Tai Chi experience (> 6 months training in past 2 years)
结局指标
主要结局
Retention
时间窗: 6 months
The percentage of study visits completed by each participant.
Rate of participant recruitment
时间窗: 24 months
Protocol adherence
时间窗: 6 months
The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm.
次要结局
- Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS)(Baseline and 6 months)
- Change from Baseline in PDQ-39(Baseline and 6 months)
- Change from Baseline in Self-Efficacy for Exercise Scale(Baseline and 6 months)
- Change from Baseline in Activity-specific Balance Confidence Scale(Baseline and 6 months)
- Change from Baseline in Physical Activity Status Scale (PASS)(Baseline and 6 months)
- Change from Baseline in Profile of Mood State(Baseline and 6 months)
- Change from Baseline in Single leg stance time(Baseline and 6 months)
- Change from Baseline in Timed Up and Go Test(Baseline and 6 months)
- Change from Baseline in Cognitive function(Baseline and 6 months)
- Change from Baseline in Steady state gait dynamics(Baseline and 6 months)
- Change from Baseline in Balance/Postural control(Baseline and 6 months)
研究者
Peter Wayne
Assistant Professor of Medicine
Harvard University Faculty of Medicine