Tai Chi and Parkinson's Disease

描述(申请人提供)：帕金森氏病(PD)是一种进行性神经系统疾病，经常导致姿势不稳定，例如失去平衡和摔倒的发生率增加。研究一直局限于确定创新的物理干预措施，以改善姿势平衡和下肢肌肉力量，以维持帕金森病患者的日常身体功能。太极是一种平衡锻炼方式，被证明在改善平衡和防止摔倒方面有效，可能对帕金森病患者有益；然而，关于太极对帕金森病的影响的证据很少。在前期工作的基础上，本申请提出了一项前瞻性、为期6个月的随机、对照、双盲临床试验，以调查帕金森病患者特定的太极锻炼计划的效果。这项研究将包括三个实验手臂：太极、常规力量训练和低冲击运动控制。这项研究的主要目的是验证这样一种假设，即特制的太极计划将改善患有轻中度帕金森病(Hoehn和Yahr分级的1、2或3级)患者的平衡和下肢肌肉力量的主要结果指标，以及身体表现、摔倒自我效能、摔倒恐惧和摔倒频率的次要结果指标。三个次要目标是研究：(A)太极干预6个月后平衡终点的改善是否与干预后6个月内跌倒的减少有关；(B)太极干预后下肢肌肉力量的增加是否调节了太极干预与平衡终点之间的关系；以及(C)太极组在试验阶段结束时在平衡和肌肉力量测量方面的进展是否将在干预后6个月的后续阶段保持。每个干预组的随机参与者(N=135)将接受60分钟的锻炼计划，每周2次，连续26周。主要和次要终点结果将在基线、3个月和6个月终止时收集，并在干预后6个月再次收集。数据将通过对连续变量的重复测量协方差分析进行分析，组内分配作为组间因素，后续评估时间作为重复测量因素，使用基线测量作为协变量。基于理论考虑和试点工作，我们假设的总体结构是太极拳在一级和二级成绩指标上表现出比力量训练条件或低冲击运动控制更好的成绩。这项研究是独一无二的，因为它代表了一种努力，为面临姿势不稳定和活动问题的PD患者样本提供一种新的运动干预。

DESCRIPTION (provided by applicant): Parkinson's disease (PD) is a progressive neurological disorder that often results in postural instability, exemplified by increasing loss of balance and incidence of falls. Research has been limited on identifying innovative physical interventions that improve postural balance and lower-extremity muscle strength to maintain daily physical functioning in individuals with PD. Tai Chi, a balance-exercise modality, shown to be effective in improving balance and preventing falls, may be beneficial for individuals with PD; however, little evidence is available concerning the effects of Tai Chi on PD. Based on preliminary work, this application proposes a prospective, 6-month randomized, controlled, double-blind clinical trial to investigate the effects of a Parkinson-specific Tai Chi exercise program in persons with PD. The study will be comprised of three experimental arms: Tai Chi, conventional strength training, and a low-impact exercise control. The primary aim of this investigation is to test the hypothesis that a specially tailored Tai Chi program will improve primary outcome measures of balance and lower-extremity muscle strength, and secondary outcome measures of physical performance, falls self-efficacy, fear of falling, and falls frequency, in persons with mild to moderate PD (stages 1, 2, or 3 of the Hoehn and Yahr scale). Three secondary aims are to examine: (a) whether improvements in the endpoint of balance resulting from the 6-month Tai Chi intervention are associated with reductions in subsequent falls during a 6-month post-intervention period; (b) whether gains in lower-extremity muscle strength following the Tai Chi intervention mediate the relationship between the Tai Chi intervention and the endpoint of balance; and (c) whether gains in balance and muscle strength measures achieved by the Tai Chi group at the end of the trial phase will be sustained during the 6-month post-intervention follow-up phase. Randomized participants (N = 135) in each intervention arm will receive a 60-minute exercise program, 2 times per week, for 26 consecutive weeks. Primary and secondary endpoint outcomes will be collected at baseline, 3 months, and at the 6-month termination, and again at 6 months post-intervention. Data will be analyzed through repeated-measures analysis of covariance on the continuous variables, with the group assignment as a between-group factor, and time to follow-up assessment as a repeated measures factor, using baseline measures as covariates. Based on theoretical considerations and pilot work, the general structure of our hypotheses is that Tai Chi will show better performance results on primary and secondary outcome measures compared to the strength training condition or the low-impact exercise control. This study is unique because it represents an effort to offer a novel exercise intervention to a sample of PD patients who are confronted with postural instability and mobility problems.