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OpenTrials
Completed

NCT Number: NCT05702216

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

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.

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Key information

Conditions

Cardiac Tele-rehabilitation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique la Mitterie

Lille, 59160, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation

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.

Primary outcomes

  1. 6-minute walk test

    Time frame: 6 weeks before baseline

    Distance covered in the 6-minute walk test

Secondary outcomes

  1. Stress test

    Time frame: 6 weeks before baseline

    12-lead electrocardiogram

  2. Wall Squat Test

    Time frame: 6 weeks before baseline

    Muscular endurance

Sponsors and collaborators

Lead sponsor

Clinique de la Mitterie

Other

Registry information

Official study title

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

Acronym: TELEREHAB

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 27, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.