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

说明(申请人提供)：心脏康复计划(CRP)可降低急性冠状动脉事件或血管重建术后康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，也在CRPS术后得到改善。然而，目前只有30%的患者参加CRPS，自然流失率可能达到60%。障碍包括年龄、女性、对CRPS中建议的运动训练类型的恐惧或不喜欢、缺乏社会支持、抑郁和与CRP中心的距离。显然，有必要开发适合那些没有参加现有课程的人的特点和需求的课程。太极是一种以轻度/中度有氧运动为基础，辅以冥想成分的心身干预方法，可以改善久坐不动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。老年人和有条件的人可以安全地练习太极拳；它不需要任何特殊的设备，可以在任何时间和地点进行。由于太极拳通常以团体形式教授，即使对高危患者也是安全的，因此它已经成功地在社区中心提供，从而克服了交通障碍，限制了成本。所有这些特点表明，太极拳可以克服传统CRP的多种障碍，可以作为不愿参加传统CRPS的患者的替代干预措施。我们的长期目标 IS正在进行一项第三阶段随机临床试验(RCT)，以确定太极在改善最近发生冠状动脉事件或接受手术但无法或不愿参加传统CRPS的患者整体体力活动方面的有效性。这项治疗发展研究的目标是确定太极干预在这一新人群中的内容、最佳剂量、可行性和安全性，并优化未来随机对照试验的设计。具体地说，(目标1)我们将使用改进的德尔福技术来开发太极干预，以满足最近发生冠状动脉事件或接受手术但无法或不愿参加传统CRP的患者的特定康复需求。接下来，(目标2)我们将通过比较两种剂量太极干预的可行性、可接受性和安全性来确定适当的干预剂量。60名患者(每组30人)将被随机分成“低剂量”太极拳(我们之前对心力衰竭患者进行的研究中使用的剂量)或“高剂量”太极拳，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。我们将获得每个剂量对体力活动的影响的估计，以及达到当前推荐体力活动的患者的比例。其他结果将包括体重、健康、生活质量、锻炼自我效能、正念、感知到的社会支持、抑郁和睡眠。测量将在注册后的基线、3个月、6个月和9个月进行。最后，(目标3)调查小组将根据剂量研究的结果对太极干预方案进行最后调整，并将最终确定未来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.