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

NCT ID: NCT05702216

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-29

Study Completion Date

2023-03-31

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.

Conditions

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Cardiac Tele-rehabilitation

Keywords

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Cardiac tele-rehabilitation, cardiac rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Cardiac rehabilitation

Group Type OTHER

Rehabilitation

Intervention Type OTHER

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.

Cardiac Tele-rehabilitation

Tele cardiac rehabilitation in hybrid form

Group Type OTHER

Rehabilitation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique de la Mitterie

OTHER

Sponsor Role lead

Responsible Party

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Michaël RACODON

clinical research coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michaël RACODON, Ph.D

Role: STUDY_DIRECTOR

CLINIQUE LA MITTERIE

Locations

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Clinique la Mitterie

Lille, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 31314680 (View on PubMed)

Other Identifiers

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N° 2021-A03116-35

Identifier Type: -

Identifier Source: org_study_id