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

December 26, 2023 updated by: Michaël RACODON, Clinique de la Mitterie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59160
        • Clinique la Mitterie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique de la Mitterie

Investigators

  • Study Director: Michaël RACODON, Ph.D, Clinique la Mitterie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2021

Primary Completion (Actual)

September 5, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N° 2021-A03116-35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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