NCT00611481已完成2 期
Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Balance
研究概览
简要总结
Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease Rating Scale, Falls, muscle strength.
详细描述
The study is designed to determine the effects of Tai Chi training on balance and other functional outcomes in persons with Parkinson's disease.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have:
- •A diagnosis of idiopathic PD, with a disease severity rating of stage I to IV on the Hoehn and Yahr scale (Hoehn & Yahr, 1967)
- •At least 1 score of 2 or more for at least 1 limb for either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS)
- •Stable medication usage
- •Not participated in a structured exercise program (i.e., not involved in any routine, organized physical activity program lasting 30 minutes or more per day, such as a gym program or regularly scheduled instructor-led exercise class) in the previous 2 months
- •Ability to stand unaided or walk independently; had a personal physician's or neurologist's clearance for participation; and had a willingness to be assigned to intervention conditions.
排除标准
- •Patients who:
- •Participate in any other behavioral or pharmacological research study
- •Have cognitive decline (Mini-Mental State Examination score, ≤ 24) (Folstein et al., 1975)
- •Have self-reported diagnosis of Alzheimer disease or other severe neurological (stage III and IV PD)
- •Have evidence of progressive or debilitating conditions (metastatic cancer, severe heart or lung disease, crippling arthritis) or severe losses in vision and hearing that would limit their tolerance to testing and training procedures, that would interfere with study participation
- •Are unavailable during the study period.
结局指标
主要结局
Balance
时间窗: 3 time points
次要结局
- gait, physical performance, Unified Parkinson's Disease Rating Scale, falls, Muscle strength(3 time points)
研究者
研究点 (2)
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