Tai Chi and Parkinson's Disease

描述（由申请人提供）：帕金森病（PD）是一种进行性神经系统疾病，通常导致姿势不稳定，例如平衡丧失和福尔斯发生率增加。研究一直局限于确定创新的物理干预措施，改善姿势平衡和下肢肌肉力量，以维持PD患者的日常身体功能。太极拳是一种平衡锻炼方式，可有效改善平衡和防止福尔斯，可能对PD患者有益;然而，关于太极拳对PD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、6个月随机、对照、双盲临床试验，以研究帕金森特异性太极运动计划对PD患者的影响。这项研究将包括三个实验组：太极拳，常规力量训练和低冲击运动控制。本研究的主要目的是检验以下假设：在轻度至中度PD患者（Hoehn和Yahr量表的1、2或3级）中，专门定制的太极拳计划将改善平衡和下肢肌肉力量的主要结局指标，以及身体表现、福尔斯自我效能、对跌倒的恐惧和福尔斯频率的次要结局指标。三个次要目的是检查：（a）6个月太极拳干预导致的平衡终点的改善是否与干预后6个月期间随后福尔斯的减少相关;（B）太极拳干预后下肢肌肉力量的增加是否介导太极拳干预和平衡终点之间的关系;以及（c）太极组在试验阶段结束时所获得的平衡和肌肉力量测量的增益是否将在干预后6个月的随访阶段期间持续。每个干预组的随机化参与者（N = 135）将接受60分钟的运动计划，每周2次，连续26周。将在基线、3个月和6个月终止时收集主要和次要终点结局，并在干预后6个月再次收集。将通过对连续变量进行重复测量协方差分析来分析数据，将组分配作为组间因素，将至随访评估的时间作为重复测量因素，将基线测量值作为协变量。基于理论上的考虑和试点工作，我们的假设的一般结构是，太极拳将显示更好的性能结果的主要和次要结果的措施相比，力量训练条件或低影响运动控制。这项研究是独一无二的，因为它代表了一种努力，提供一种新的运动干预的样本PD患者谁面临着姿势不稳定和流动性问题。

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.