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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Tele-rehabilitation

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization in two groups: a Hybrid Tele-pulmonary Rehabilitation group and a classic Rehabilitation group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiac rehabilitation<br> | Other: Rehabilitation<br>* Hybrid approach in cardiac telerehabilitation. Patients underwent 20 cardiac rehabilitation sessions: alternatively, patients underwent 10 classical cardiac rehabilitation sessions in the clinic and 10 cardiac telerehabilitation sessions at home.<br>|
| Other: Cardiac Tele-rehabilitation<br>Tele cardiac rehabilitation in hybrid form | Other: Rehabilitation<br>* Hybrid approach in cardiac telerehabilitation. Patients underwent 20 cardiac rehabilitation sessions: alternatively, patients underwent 10 classical cardiac rehabilitation sessions in the clinic and 10 cardiac telerehabilitation sessions at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test | Distance covered in the 6-minute walk test | 6 weeks before baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress test | 12-lead electrocardiogram | 6 weeks before baseline | 
| Wall Squat Test | Muscular endurance | 6 weeks before baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac tele-rehabilitation, cardiac rehabilitation