CLINICAL TRIAL: EFFECT OF CARDIAC REHAB ON RECOVERY FROM A CORONARY EVENT IN OLD

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 背景高龄人群发生冠状动脉事件后，心脏康复对功能恢复的影响尚不清楚。作为一个主要目标，我们打算评估心脏康复与高强度有氧和阻力训练对在模拟居家实验室中的特定体力活动的影响，在非常老年的人群中。我们的次要目标是评估心脏康复对身体机能指标(测量的体能测试和问卷调查)和身体成分的影响。 方法本研究为前瞻性对照临床研究。研究小组将包括由居住在伯灵顿地区的10名75岁以上的老年患者组成的积极治疗组，以及由来自佛蒙特州或纽约州北部偏远地区的10名类似患者组成的对照组，那里没有心脏康复服务。参与者将从Fletcher Allen Health Care招募，同时因冠状动脉事件住院，如心肌梗死、冠状动脉血管重建术(冠状动脉搭桥手术或经皮血管重建术)或急性冠状动脉综合征。对于心脏康复组的患者，运动训练将包括为期4个月的36节有氧运动和阻力训练(标准护理)。控制组的受试者将由他们的私人心脏病医生照常进行护理，他们应该建议根据目前的二级预防指南进行锻炼。在治疗前和治疗4个月后，采用PFP-10对患者进行身体功能评定。PFP-10的结果构成了我们的主要终点。这项测试已经在多个临床人群中得到验证。它使用时间、距离和负重来评估身体功能，基于10项连续执行的常见家务任务的表现。这10项任务被报告为五个独立物理域的平均总分(0-100)。这些领域包括1)上半身力量，2)下半身力量，3)上半身柔韧性，4)平衡和协调，5)耐力。身体机能也将通过要求参与者执行特定任务的其他测试来测量：短身体性能电池(SPPB)、峰值氧耗(峰值VO2)和峰值运动能力、单次重复最大升降量(1 RM)和计步器的4天步数。此外，还将通过问卷、医疗结果研究36项简式问卷(MOS SF-36和SF-36 PF)、老年抑郁量表(GDS)、日常生活能力(ADLS)问卷和Champs身体活动问卷对患者的身体功能进行评估。还将使用身体质量指数(BMI)和双能X射线吸收法(DEXA)扫描进行身体成分分析。通过对20名参与者的计算，本研究将有99%的能力检测到积极治疗组的PFP-10得分提高了14分，双边p值为0.05。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Background The effect of cardiac rehabilitation on functional recovery following a coronary event in the very elderly population is not well known. We intend to evaluate, as a primary objective, the impact of cardiac rehabilitation with both intense aerobic and resistance training on specific measured physical activities in a simulated home-setting laboratory, in the very old population. Our secondary objective is to evaluate the impact of cardiac rehabilitation on other on physical function indicators (measured physical performance tests and questionnaires) and body composition. Methods This is a prospective controlled clinical study. The study groups will include an active treatment group composed of 10 elderly patients aged over 75 years, living in the Burlington area, and a control group composed of 10 similar patients from remote areas of Vermont or upstate New York, where cardiac rehabilitation is not available. Participants will be recruited from Fletcher Allen Health Care while hospitalized for a coronary event, such as myocardial infarction, coronary revascularization (either coronary artery bypass surgery or percutaneous revascularization), or acute coronary syndrome. For the patients in the cardiac rehabilitation group, the exercise training will consist of 36 sessions of aerobic exercise and resistance training over a 4 months period (standard of care). Subjects in the control group will be managed as usual care by their personal cardiologist, who should recommend doing exercise in accordance with current guidelines for secondary prevention. Before and after the 4-months period patients will be tested with the Physical Functional Performance-10 (PFP-10). The result of the PFP-10 constitutes our primary end-point. This test has been validated in multiple clinical populations. It uses time, distance, and weight carried to evaluate physical function, based on the performance of 10 sequentially performed common household tasks. The 10 tasks are reported as a total score (0-100) averaging five separate physical domains. The domains are 1) upper-body strength, 2) lower-body strength, 3) upper-body flexibility, 4) balance and coordination, and 5) endurance. Physical function will also be measured by means of other tests requiring the participants to perform specific tasks; Short Physical Performance Battery (SPPB), peak oxygen consumption (peak VO2), and peak exercise capacity, single-repetition maximal lifts (1 RM), and 4 day step counts with pedometer. In addition, self reported physical function will be assessed by means of questionnaires; Medical Outcomes Study 36-Item Short-Form Survey (MOS SF-36and SF-36 Physical Function (SF-36 PF), Geriatric Depression Scale (GDS), Activities of Daily Living (ADLs) questionnaire, and CHAMPS physical activity questionnaire. A body composition analysis using body mass index (BMI) and Dual Energy X-Ray Absorptiometry (DEXA)-Scan will also be performed. With 20 participants we calculated that the present study will have a power of 99 % to detect a PFP-10 score improvement of 14 in the active treatment group, with a two-sided p-value of 0.05.