跳至主要内容
临床试验/NCT05689385
NCT05689385招募中不适用

The Effectiveness of eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients:a Randomized Controlled Trial.

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Change of ventilatory anaerobic threshold

研究概览

简要总结

The goal of this randomized controlled trial is to compare the effect of eHealth-based cardiac rehabilitation with the effect of usual care on exercise capacity and qualify of life in patients after myocardial infarction.

详细描述

Cardiac rehabilitation can improve exercise capacity, life of quality, readmission rate and mortality rate for patients after myocardial infarction. International guidelines list cardiac rehabilitation after myocardial infarction as class IA recommendation. However, low participation rate of cardiac rehabilitation due to barriers such as lacking of time, transport or affordability issues is an unsolved problem worldwide.

eHealth, consisting of telemedicine, mobile health and personalized care using wearable devices has the potential to remove the barriers and become an effective model to deliver cardiac rehabilitation. Thus, we design a randomized controlled trial to compare the effect of a case manager-led eHealth-based cardiac rehabilitation program with usual care on the compliance, physical activity, quality of life, and cardiorespiratory fitness in patients after myocardial infarction.

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)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change of ventilatory anaerobic threshold

时间窗: at baseline, 12 weeks(post-intervention), and 12 months.

Ventilatory anaerobic threshold will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.

Change of peak oxygen uptake

时间窗: at baseline, 12 weeks(post-intervention), and 12 months.

Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.

次要结局

  • Evaluation of Quality of life(at baseline, 12 weeks(post-intervention), and 12 months.)
  • Anxiety(at baseline, 12 weeks(post-intervention), and 12 months.)
  • Evaluation of physical activity(at baseline, 12 weeks(post-intervention), and 12 months.)
  • Adherence to prescribed exercise(at 12 weeks(post-intervention) and 12 months.)
  • Depression(at baseline, 12 weeks(post-intervention), and 12 months.)
  • Evaluation of grip strength(at baseline, 12 weeks(post-intervention), and 12 months.)
  • Evaluation of isometric knee extension strength(at baseline, 12 weeks(post-intervention), and 12 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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