Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Quality of Life (QOL)
研究概览
简要总结
The PREPARE TAVR pilot study will examine the effects of remotely administered physiological reconditioning program (RAPR) on quality of life (QOL) and clinical outcomes at one year post TAVR in frail older adults.
详细描述
The main objective of this study is to evaluate the effects of a home based exercise and dietary intervention program on the quality of life (QOL) and clinical outcomes in frail adults undergoing Transcatheter aortic valve replacement (TAVR) procedures. Patients will be randomly (1:1) assigned to the standard of care (SOC group) where patients will receive all medical care as decided by their treating physicians or assigned to a home based program known as remotely administered physiological reconditioning (RPR) program which will include receiving personalized instructions for a progressive exercise program and dietary changes. Patients will be contacted for regular phone and in-person follow up for monitoring their progress. The primary endpoint will be quality of life as assessed by KCCQE questionnaires at one-year post TAVR. The secondary endpoints include length of stay post TAVR, all-cause mortality, repeat hospitalization and a composite of all-cause mortality and repeat hospitalization at one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessed in a blinded manner
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Short Physical Performance Battery Protocol (SPPB) score < 9
排除标准
- •Severe liver disease defined by Childs Pugh class >B or MELD score >
- •Severe kidney disease defined by eGFR <30 mL/min.
- •Hospital admission during the 4 weeks prior to randomization.
- •Montreal objective cognitive assessment (MOCA) score <
- •Mechanical fall in the past month.
- •Unstable angina during the previous month.
- •Myocardial infarction during the previous month.
- •Unsuccessful completion of the one-week run-in phase.
- •Syncopal episode during exercise during run-in phase
结局指标
主要结局
Quality of Life (QOL)
时间窗: One year
Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQE is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best.
次要结局
- LOS(Index hospitalization)
- MACE(one year)