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

描述（由申请方提供）：心脏康复计划（CRP）可降低急性冠状动脉事件或血运重建手术后恢复患者的总体死亡率和心血管死亡率。可改变的冠状动脉危险因素，如缺乏运动，超重和高血脂水平也改善后CRP。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，对CRP中提出的运动训练类型的恐惧或不喜欢，缺乏社会支持，抑郁和距离CRP中心。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，它改善了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。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。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。所有这些特征表明，太极拳可以克服传统CRP的多重障碍，并可作为不愿意参加传统CRP的患者的替代干预措施。我们的长期目标 正在进行一项III期随机临床试验（RCT），以确定太极拳在改善近期发生冠状动脉事件或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目的是确定太极拳干预在这一新人群中的内容、最佳剂量、可行性和安全性，并优化未来RCT的设计。具体而言，（目标1）我们将使用改良的德尔菲技术开发一种太极干预，以满足近期发生冠状动脉事件或手术的患者的特定康复需求，这些患者不能或不愿意参加传统的CRP。接下来，（目标2）我们将通过比较两种剂量的太极拳干预的可行性，可接受性和安全性来确定干预的适当剂量。60名患者（每个剂量组30名）将被随机分配到“低剂量”太极拳（我们先前对心力衰竭患者进行的研究中使用的剂量）或“高剂量”，该剂量与当前CRP中运动课程的频率和持续时间的当前建议相匹配。我们将获得每种剂量对体力活动和达到当前体力活动建议的患者比例的影响估计值。其他结果将是体重，健身，生活质量，运动自我效能，正念，感知社会支持，抑郁和睡眠。将在基线、入组后3个月、6个月和9个月进行测量。最后，（目标3）研究小组将根据剂量研究的结果对太极干预方案进行最终调整，并最终确定未来RCT的设计。

DESCRIPTION (provided by applicant): Cardiac rehabilitation programs (CRP) reduce overall and cardiovascular mortality in patients recovering from acute coronary events or revascularization procedures. Modifiable coronary risk factors such as physical inactivity, overweight and high serum lipid levels also improve after CRPs. However, only 30% of patients currently enroll in CRPs and attrition may reach 60%. Barriers include older age, female gender, fear or dislike for the type of exercise training proposed in CRPs, lack of social support, depression and distance from CRP center. 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, has improved aerobic capacity in older sedentary adults as well as exercise self-efficacy, quality of life and mood in patients with heart failure. 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. 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. All these characteristics indicate that Tai Chi may overcome multiple barriers to traditional CRP and could be proposed as an alternative intervention for patient unwilling to attend traditional CRPs. 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 objectives of this treatment development study are to define the content, optimal dose, feasibility and safety of a Tai Chi intervention in this new population and to optimize the design of the future RCT. Specifically, (aim 1) we will use a modified Delphi technique to develop a Tai Chi intervention tailored to the specific rehabilitative needs of patients with recent coronary events or procedures that are unable or unwilling to attend traditional CRPs. Next, (aim 2) we will define the appropriate dose of the intervention by comparing the feasibility, acceptability and safety of two doses of the Tai Chi intervention. 60 patients (30 per dose arm) will be randomized to a "low dose" of Tai Chi (the dose used in our previous studies with heart failure patients) or to a "high dose" matching current recommendations for the frequency and duration of exercise classes in current CRPs. We will obtain estimates of the effect of each dose on physical activity and on the proportion of patients achieving current recommendation for physical activity. Additional outcomes will be body weight, fitness, quality of life, exercise self-efficacy, mindfulness, perceived social suppor, depression and sleep. Measurements will be conducted at baseline, 3-, 6-, and 9- months after enrollment. Lastly, (aim 3) the investigative team will make the final adjustments to the Tai Chi intervention protocol based on findings from the dosing study and will finalize the design of the future RCT.