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

March 1, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-étienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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
Months: 0, 2

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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