Development of a Tai Chi Program to Overcome Barriers to Cardiac Rehabilitation

描述（由申请人提供）：心脏康复计划（CRP）可降低心肌梗死、心绞痛和冠状动脉血运重建后患者的心血管死亡率。可改变的冠状动脉危险因素，如缺乏运动、超重和高血脂水平，在CRP后改善。然而，目前只有30%的患者入组CRP，流失率可能达到60%。障碍包括年龄较大、女性、缺乏社会支持、高共同支付、距离、抑郁以及害怕或不喜欢某些类型的运动。显然，有必要制定适合那些没有参加目前可用方案的人的特点和需求的方案。太极拳是一种基于轻度/中度有氧运动并伴有冥想成分的身心干预，可改善久坐的老年人的有氧能力，以及心力衰竭患者的运动自我效能、生活质量和情绪。此外，太极拳可以克服传统CRP的多重障碍。太极拳可以由老年人和残疾人安全地练习;它不需要任何特定的设备，可以在任何时间和地点进行，从而促进坚持。由于太极拳通常是以小组形式教授的，即使在高危患者中也是安全的，因此它已成功地在社区中心提供，从而克服了交通障碍并限制了成本。我们的长期目标是进行一项III期随机临床试验（RCT），以确定太极拳在改善近期冠状动脉事件或程序无法或不愿意参加传统CRP的患者的整体体力活动方面的疗效。这项治疗开发研究的总体目标是确定太极拳干预在该人群中的内容、最佳剂量、可行性和安全性;并完善未来RCT的设计。具体而言，我们将使用迭代改良的德尔菲技术，使心力衰竭患者的现有太极干预方案和材料适应我们特定的研究人群（目的1），并为未来的RCT选择最佳对照组（目的2）。在一小组（n=10）患者中进行太极干预的可接受性初步预试验测试（目标3）后，60名患者（每剂30名）将被随机分配到“标准剂量”或“高剂量”干预（目标4）。我们将估计每种剂量的可行性和安全性，并获得相对于基线体力活动变化（使用加速计评估）的效应量估计值和达到当前体力活动建议的患者比例。其他结果将是体重，生活质量，情绪和感知的社会支持。将在基线、入组后3个月、6个月和12个月进行测量。根据目标4的调查结果，调查小组将对太极干预方案（目标5）进行最终调整。从拟议的研究中产生的数据将导致III期随机对照试验的设计，以评估太极拳在促进近期冠状动脉事件或程序不能或不愿意参加传统CRP的患者的身体活动方面的疗效。

DESCRIPTION (provided by applicant): Cardiac rehabilitation programs (CRP) reduce cardiovascular mortality in patients with myocardial infarction, angina and after coronary revascularization. Modifiable coronary risk factors such as physical inactivity, overweight and high serum lipid levels improve after CRPs. However, only 30% of patients currently enroll in CRPs and attrition may reach 60%. Barriers include older age, female gender, lack of social support, high co-pays, distance, depression and fear or dislike for certain types of exercise. Clearly, there is a need to develop programs tailored to the characteristics and needs of those who do not attend presently available programs. Tai Chi, a mind-body intervention based on light/moderate aerobic exercise accompanied by meditative components, improves aerobic capacity in older sedentary adults, as well as exercise self-efficacy, quality of life and mood in patients with heart failure. In addition, Tai Chi may overcome multiple barriers to traditional CRP. Tai Chi can be practiced safely by elderly and deconditioned individuals; it does not require any particular equipment and it may be performed at any time and place, thus fostering adherence. Since Tai Chi is usually taught in groups, and is safe even in high-risk patients, it has been successfully offered in community centers thus overcoming transportation barriers and limiting costs. Our long-term goal is conduct a phase III randomized clinical trial (RCT) to determine the efficacy of Tai Chi in improving overall physical activity in patients with recent coronary events or procedures that are unable or unwilling to attend traditional CRPs. The overall objectives of this treatment development study are to define the content, optimal dose, feasibility and safety of a Tai Chi intervention in this population; and to refine the design of th future RCT. Specifically, we will use an iterative modified Delphi technique to adapt the protocol and materials of an existing Tai Chi intervention for patients with heart failure to our specific study population (aim 1) and to select the optimal control group(s) for the future RCT (aim 2). After a preliminary pre-pilot testing of the acceptability of the Tai Chi intervention in a small (n=10) group of patients (aim 3), 60 patients (30 per dose) will be randomized to a "standard dose" or to a "high dose" of the intervention (aim 4). We will estimate the feasibility and safety f each dose and obtain estimates of effect size on changes from baseline physical activity (assessed with accelerometers) and on the proportion of patients achieving current recommendation for physical activity. Additional outcomes will be body weight, quality of life, mood, and perceived social support. Measurements will be conducted at baseline, 3-, 6-, and 12 months after enrollment. Based on findings from aim 4, the investigative team will make the final adjustments to the Tai Chi intervention protocol (aim 5). Data generated from the proposed study will lead to the design of a phase III RCT to assess the efficacy of Tai Chi in promoting physical activity in patients with recent coronary events or procedures that are unable or unwilling to attend traditional CRPs.