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

临床试验：心脏康复对老年人冠状动脉事件恢复的影响

• 批准号: 8166978
• 负责人: MARIE C AUDELIN
• 金额: $ 0.34万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166978
• 关键词: Activities of Daily Living; Aerobic; Aerobic Exercise; Area; Body Composition; Body mass index; Cardiac; Clinical; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Control Groups; Coronary; Coronary Artery Bypass; Dual-Energy X-Ray Absorptiometry; Elderly; Equilibrium; Event; Exercise; Funding; Grant; Guidelines; Healthcare; Home environment; Household; Institution; Laboratories; Life; Lifting; Measures; Medical; Methods; Myocardial Infarction; New York; Older Population; Outcome Study; Oxygen Consumption; Participant; Patient Self-Report; Patients; Performance; Physical Function; Physical activity; Population; Questionnaires; Recovery; Recovery of Function; Recruitment Activity; Rehabilitation therapy; Reporting; Research; Research Personnel; Resources; SF-36; Scanning; Secondary Prevention; Side; Simulate; Source; Surveys; Testing; Training; United States National Institutes of Health; Vermont; Weight; active method; acute coronary syndrome; aged; base; flexibility; geriatric depression; older patient; performance tests; prospective; standard of care; strength training; time use; treatment as usual

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-36) and 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 greater than 99% to detect a PFP-10 score improvement of 14 in the active treatment group, with a two-sided p-value of 0.05.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 心脏康复对高龄人群冠状动脉事件后功能恢复的影响尚不清楚。 我们打算评估，作为一个主要目标，心脏康复与高强度有氧和阻力训练的影响，在一个模拟的家庭环境实验室，在非常老的人口具体测量的身体活动。 我们的次要目的是评估心脏康复对其他身体功能指标（测量的身体性能测试和问卷）和身体成分的影响。 方法采用前瞻性对照临床研究。 研究组将包括一个积极治疗组，由10名年龄超过75岁的老年患者组成，居住在伯灵顿地区，以及一个对照组，由10名来自佛蒙特州或纽约北部偏远地区的类似患者组成，那里没有心脏康复。 受试者将从弗莱彻艾伦医疗中心招募，同时因冠状动脉事件住院，如心肌梗死、冠状动脉血运重建（冠状动脉旁路手术或经皮血运重建）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4个月内的36次有氧运动和阻力训练（标准治疗）。 对照组中的受试者将由其个人心脏病专家按照常规护理进行管理，心脏病专家应建议根据现行二级预防指南进行运动。 在4个月期间之前和之后，将使用身体功能表现-10（PFP-10）对患者进行测试。 PFP-10的结果是我们的主要终点。 该试验已在多个临床人群中得到验证。 它使用时间、距离和体重来评估身体功能，基于10个顺序执行的常见家务任务的表现。 这10项任务被报告为总分（0-100），平均为5个独立的物理领域。这些领域是1）上身力量，2）下身力量，3）上身灵活性，4）平衡和协调，以及5）耐力。 还将通过要求受试者执行特定任务的其他测试测量身体功能;短体能测试组合（SPPB）、峰值耗氧量（峰值VO 2）和峰值运动能力、单次重复最大提升（1 RM）和使用计步器的4天步数。 此外，将通过问卷调查、医学结局研究36项简表调查（MOS SF-36）和SF-36身体功能（SF-36 PF）、老年抑郁量表（GDS）、日常生活活动（ADL）问卷和CHAMPS身体活动问卷评估自我报告的身体功能。 还将使用体重指数（BMI）和双能X线吸收测定法（DEXA）-扫描进行身体成分分析。 在20例受试者中，我们计算出本研究将有99%以上的把握度检测到活性治疗组的PFP-10评分改善14，双侧p值为0.05。