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Clinical Trials/NCT05702216
NCT05702216
Completed
Not Applicable

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 Mitterie1 site in 1 country60 target enrollmentOctober 29, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Tele-rehabilitation
Sponsor
Clinique de la Mitterie
Enrollment
60
Locations
1
Primary Endpoint
6-minute walk test
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2021
End Date
March 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Clinique de la Mitterie
Responsible Party
Principal Investigator
Principal Investigator

Michaël RACODON

clinical research coordinator

Clinique de la Mitterie

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

6-minute walk test

Time Frame: 6 weeks before baseline

Distance covered in the 6-minute walk test

Secondary Outcomes

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

Study Sites (1)

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