Non-inferiority Study of a Cardiac Tele-rehabilitation in Hybrid Form Compared to a Cardiac Rehabilitation

Not Applicable

Completed

• Conditions: Cardiac Tele-rehabilitation
• Interventions: Other: Rehabilitation

• Registration Number: NCT05702216
• Lead Sponsor: Clinique de la Mitterie

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.

Study Timeline

• Study Start: 2021-10-29
• Primary Completion: 2022-09-05
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Study Completion: 2023-03-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-26
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac Tele-rehabilitation	Rehabilitation	Tele cardiac rehabilitation in hybrid form
Cardiac rehabilitation	Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
6-minute walk test	6 weeks before baseline	Distance covered in the 6-minute walk test

Secondary Outcome Measures

Name	Time	Method
Wall Squat Test	6 weeks before baseline	Muscular endurance
Stress test	6 weeks before baseline	12-lead electrocardiogram

Trial Locations

Locations (1)

Clinique la Mitterie; 🇫🇷 Lille, France