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

Cardiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05749744
• Other study ID #: IRBN1022021/CHUSTE
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	oxygen (VO2) peak	Variation of oxygen (VO2) peak before and after 15 training sessions performed	Months: 0, 2
Secondary	maximum power workload	Variation of maximum power workload before and after 15 training sessions performed	Months: 0, 2
Secondary	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
Secondary	maximum heart rate	Variation of maximum heart rate before and after 15 training sessions performed.	Months: 0, 2
Secondary	recovery heart rate	Variation of recovery heart rate before and after 15 training sessions performed.	Months: 0, 2
Secondary	obstructive ventilatory disorder	Variation of obstructive ventilatory disorder before and after 15 training sessions performed.	Months: 0, 2
Secondary	autonomic nervous system	Variation of autonomic nervous system before and after 15 training sessions performed.	Months: 0, 2
Secondary	muscular strength	Variation of muscular strength before and after 15 training sessions performed.	Months: 0, 2
Secondary	muscular endurance	Variation of muscular endurance before and after 15 training sessions performed.	Months: 0, 2