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临床试验/NCT05702216
NCT05702216已完成不适用

Étude de Non-infériorité d'un Programme de télé-réadaptation Cardiovasculaire Sous Une Forme Hybride Par Rapport à Une rééducation réadaptation Cardiovasculaire Classique

Clinique de la Mitterie2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
6-minute walk test

研究概览

简要总结

Cardiac tele-rehabilitation in a hybrid form can be a choise for the management of cardiovascular diseases. The aim is to increase the participation rate of patients in cardiac rehabilitation.

This new form of care can be as effective as traditional care.

详细描述

The Covid-19 pandemic has had indirect effects on the health system, particularly in the management of cardiovascular diseases. Rehabilitation centres had to adapt their operation to the recommendations of health authorities. The choice appeared to be unavoidable: tele-rehabilitation care in a hybrid form. Moreover, Many patients do not participate at this kind of care. Many identified factors can explain this low rate of participation : a lack of proximity facilities does not promote patient participation.

The objective of this study is to demonstrate a comparable effectiveness between a cardiac telerehabilitation programme in hybrid form and a cardiac classic rehabilitation programme.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 ans
  • Patients with heart disease
  • Inclusion in the rehabilitation program

排除标准

  • Cardiac decompensation
  • No stabilised acute coronary syndrome
  • Decompensated heart failure
  • Severe ventricular rhythm disorders
  • Severe functional limitation

结局指标

主要结局

6-minute walk test

时间窗: 6 weeks before baseline

Distance covered in the 6-minute walk test

次要结局

  • Wall Squat Test(6 weeks before baseline)
  • Stress test(6 weeks before baseline)

研究者

发起方
Clinique de la Mitterie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michaël RACODON

clinical research coordinator

Clinique de la Mitterie

研究点 (2)

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