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Completed

NCT Number: NCT05749744

Effects of Cardiac Telerehabilitation During COVID-19 on Cardiorespiratory Capacities in Coronary Artery Disease Patients.

After an acute coronary syndrome, an adapted cardiac rehabilitation program is necessary to restore or increase physical capacities and decrease cardiovascular risk. This multidisciplinary care combines physical training sessions and therapeutic education workshops.

The COVID-19 pandemic imposed restrictions such as the closure of rehabilitation centres. To remedy this problem, one solution was to adapt the existing program to a remote cardiac telerehabilitation, i.e., medical and paramedical supervision of rehabilitation sessions and therapeutic patient education meetings via digital tools. Recent studies have shown that it was a safe (no reported adverse effects), effective (similar gains in peak oxygen consumption compared to traditional cardiac rehabilitation and patient-adherence alternative.

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Key information

Conditions

Cardiac Disease Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, France

About this study

The hypothesis of this study is that telerehabilitation was more effective on cardiorespiratory functions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Both groups:

  • Acute Coronary Syndrome treated in the last 6 months
  • Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)

For Telerehabilitation group:

  • Internet connexion (computer or digital tablet)
  • Equipped with an exercise bike

Exclusion criteria

Both groups:

  • Pulmonary hypertension
  • Aortic pathway anomaly
  • Uncontrolled ventricular rhythm disorders

For Telerehabilitation group:

  • Important muscular deconditioning
  • Patient requiring medical supervision in institute

Treatment and study plan

cardiac telerehabilitation program by videoconference

Other
  • A video conference interview with an Adapted Physical Activity (APA) teacher before starting physical training
  • Exercise training for 3 weeks via distance coaching
  • Therapeutic patient education (TPE) workshops conducted remotely with 1 workshop per week.
  • Medical follow-up via teleconsultation
  • Psychological and/or dietetic follow-up if necessary.
  • Final assessment at 1 month with evaluation of aerobic metabolism, functional evaluation and final shared educational assessment (BEP).
  • Appointment with an association "Cœur et Santé" and "Sport-Santé 42" or setting up of an individual physical activity

Primary outcomes

  1. Change from Baseline oxygen (VO2) (ml/min/kg) at the first ventilatory threshold (VT1) at 2 months

    Time frame: Months: 0, 2

    Variation of oxygen (VO2) (ml/min/kg) at the first ventilatory threshold (VT1) during a cardio-pulmonary exercise test (CPET) before and after 15 training sessions performed

Secondary outcomes

  1. oxygen (VO2) peak

    Time frame: Months: 0, 2

    Variation of oxygen (VO2) peak before and after 15 training sessions performed

  2. maximum power workload

    Time frame: Months: 0, 2

    Variation of maximum power workload before and after 15 training sessions performed

  3. power at the first ventilatory threshold (VT1)

    Time frame: Months: 0, 2

    Variation of power at the first ventilatory threshold (VT1) before and after 15 training sessions performed

  4. maximum heart rate

    Time frame: Months: 0, 2

    Variation of maximum heart rate before and after 15 training sessions performed.

  5. recovery heart rate

    Time frame: Months: 0, 2

    Variation of recovery heart rate before and after 15 training sessions performed.

  6. obstructive ventilatory disorder

    Time frame: Months: 0, 2

    Variation of obstructive ventilatory disorder before and after 15 training sessions performed.

  7. autonomic nervous system

    Time frame: Months: 0, 2

    Variation of autonomic nervous system before and after 15 training sessions performed.

  8. muscular strength

    Time frame: Months: 0, 2

    Variation of muscular strength before and after 15 training sessions performed.

  9. muscular endurance

    Time frame: Months: 0, 2

    Variation of muscular endurance before and after 15 training sessions performed.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2023
Registry last updated
Mar 3, 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.

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