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

Sponsor

Clinique de la Mitterie (Other)

Overall Status

Recruiting

CT.gov ID

NCT05702216

Collaborator

(none)

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Tele-rehabilitation	Other: Rehabilitation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomization in two groups: a Hybrid Tele-pulmonary Rehabilitation group and a classic Rehabilitation group.Randomization in two groups: a Hybrid Tele-pulmonary Rehabilitation group and a classic Rehabilitation group.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Dec 5, 2022

Anticipated Primary Completion Date :

Dec 18, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Cardiac rehabilitation	Other: Rehabilitation 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.
Other: Cardiac Tele-rehabilitation Tele cardiac rehabilitation in hybrid form	Other: Rehabilitation 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.

Arm

Intervention/Treatment

Other: Cardiac rehabilitation

Other: Rehabilitation

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.

Other: Cardiac Tele-rehabilitation

Tele cardiac rehabilitation in hybrid form

Other: Rehabilitation

Outcome Measures

Primary Outcome Measures

6-minute walk test [6 weeks before baseline]
Distance covered in the 6-minute walk test

Secondary Outcome Measures

Stress test [6 weeks before baseline]
12-lead electrocardiogram
Wall Squat Test [6 weeks before baseline]
Muscular endurance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique la Mitterie	Lille		France	59160

Sponsors and Collaborators

Clinique de la Mitterie

Investigators

Study Director: Michaël RACODON, Ph.D, CLINIQUE LA MITTERIE

Study Documents (Full-Text)

None provided.

More Information

Publications

Racodon M, Peze T, Masson P. Analysis of physical exercise in cardiac patients following cardiovascular rehabilitation. Acta Cardiol. 2020 Nov;75(7):598-603. doi: 10.1080/00015385.2019.1639269. Epub 2019 Jul 17.

Responsible Party:

Michaël RACODON, clinical research coordinator, Clinique de la Mitterie

ClinicalTrials.gov Identifier:

NCT05702216

Other Study ID Numbers:

N° 2021-A03116-35

First Posted:

Jan 27, 2023

Last Update Posted:

Jan 30, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michaël RACODON, clinical research coordinator, Clinique de la Mitterie

Cardiac tele-rehabilitation, cardiac rehabilitation

Study Results

No Results Posted as of Jan 30, 2023