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临床试验/NCT05201976
NCT05201976已完成不适用

A Clinical Trial Investigating the Effects of a Virtually Implemented Home Based Cardiac Rehab Program with Real-time, Video-based Exercise Supervision and Vitals Monitoring

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Change in VO2 max (ml/kg/min)

研究概览

简要总结

A clinical trial investigating the effects of a virtually implemented home-based cardiac rehab program with real-time, video based exercise supervision and vitals monitoring.

详细描述

This study will use a randomized, controlled trial design to test the effectiveness of a virtually implemented cardiac rehabilitation (CR) program with real-time, video based supervised exercise and vitals monitoring as compared to traditional center based rehab in patients with a clinical indication for cardiac rehab. The primary outcome of effectiveness will be change in cardiorespiratory fitness as assessed by maximal VO2 achieved at the start of CR and on upon completion of CR.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have been prescribed cardiac rehabilitation as part of their standard of care

排除标准

  • Patients with significant exercise limitations other than cardiovascular disease
  • Patients who are unable to exercise in home
  • Patients with active cancer treatment
  • Patients who do not have an email address or a cell phone

结局指标

主要结局

Change in VO2 max (ml/kg/min)

时间窗: At baseline visit and at the end of study approximately 40 weeks

Cardiorespiratory fitness as assessed by maximal VO2

次要结局

  • Quality of Life questionnaire(Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks)
  • Attendance(Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions.)
  • Blood Pressure(Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions.)
  • Change in LDL(Labs will be collected up to 27 months post study enrollment)
  • Major adverse cardiovascular events (MACE)(Events will be collected up to 27 months post study enrollment)
  • Survey(At completion of cardiac rehabilitation program approximately 36 weeks)
  • Change in HDL(Labs will be collected up to 27 months post study enrollment)
  • Change in triglycerides(Labs will be collected up to 27 months post study enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neel Chokshi

Principal Investigator

University of Pennsylvania

研究点 (2)

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