Clinical trial NCT05749744: Effects of Cardiac Telerehabilitation During COVID-19 on Cardiorespiratory Capacities in Coronary Artery Disease Patients.
Official title: Effects of Cardiac Telerehabilitation During COVID-19 on Cardiorespiratory Capacities in Coronary Artery Disease Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: cardiac telerehabilitation
acute coronary syndrome
rehabilitation therapeutic
rehabilitation sessions
cardiorespiratory functions
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient Acute Coronary Syndrome treated in the last 6 months will be included.

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline oxygen (VO2) (ml/min/kg) at the first ventilatory threshold (VT1) at 2 months
timeFrame: Months: 0, 2
Secondary outcomes:
measure: oxygen (VO2) peak
timeFrame: Months: 0, 2
measure: maximum power workload
timeFrame: Months: 0, 2
measure: power at the first ventilatory threshold (VT1)
timeFrame: Months: 0, 2
measure: maximum heart rate
timeFrame: Months: 0, 2
measure: recovery heart rate
timeFrame: Months: 0, 2
measure: obstructive ventilatory disorder
timeFrame: Months: 0, 2
measure: autonomic nervous system
timeFrame: Months: 0, 2
measure: muscular strength
timeFrame: Months: 0, 2
measure: muscular endurance
timeFrame: Months: 0, 2
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David Hupin, MD
role: PRINCIPAL_INVESTIGATOR
References: