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.

Study Overview

• Status: Completed
• Conditions: Cardiac Disease
• Intervention / Treatment: Other: cardiac telerehabilitation program by videoconference

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient Acute Coronary Syndrome treated in the last 6 months will be included.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Home-based cardiac telerehabilitation (interventional group); Patients followed the cardiac rehabilitation program at home.	Other: cardiac telerehabilitation program by videoconference; 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
Traditional centre-based cardiac rehabilitation (control group); Patients participates in the cardiac rehabilitation program in hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline oxygen (VO2) (ml/min/kg) at the first ventilatory threshold (VT1) at 2 months	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	Months: 0, 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen (VO2) peak	Variation of oxygen (VO2) peak before and after 15 training sessions performed	Months: 0, 2
maximum power workload	Variation of maximum power workload before and after 15 training sessions performed	Months: 0, 2
power at the first ventilatory threshold (VT1)	Variation of power at the first ventilatory threshold (VT1) before and after 15 training sessions performed	Months: 0, 2
maximum heart rate	Variation of maximum heart rate before and after 15 training sessions performed.	Months: 0, 2
recovery heart rate	Variation of recovery heart rate before and after 15 training sessions performed.	Months: 0, 2
obstructive ventilatory disorder	Variation of obstructive ventilatory disorder before and after 15 training sessions performed.	Months: 0, 2
autonomic nervous system	Variation of autonomic nervous system before and after 15 training sessions performed.	Months: 0, 2
muscular strength	Variation of muscular strength before and after 15 training sessions performed.	Months: 0, 2
muscular endurance	Variation of muscular endurance before and after 15 training sessions performed.	Months: 0, 2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: acute coronary syndrome; cardiac telerehabilitation; rehabilitation therapeutic; rehabilitation sessions; cardiorespiratory functions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: IRBN1022021/CHUSTE

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