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

点击翻译按钮获取中文摘要

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.