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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT05749744
Collaborator
(none)
54
1
9
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cardiac telerehabilitation program by videoconference

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
54 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Effects of Cardiac Telerehabilitation During COVID-19 on Cardiorespiratory Capacities in Coronary Artery Disease Patients.
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

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

  1. oxygen (VO2) peak [Months: 0, 2]

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

  2. maximum power workload [Months: 0, 2]

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

  3. power at the first ventilatory threshold (VT1) [Months: 0, 2]

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

  4. maximum heart rate [Months: 0, 2]

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

  5. recovery heart rate [Months: 0, 2]

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

  6. obstructive ventilatory disorder [Months: 0, 2]

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

  7. autonomic nervous system [Months: 0, 2]

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

  8. muscular strength [Months: 0, 2]

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

  9. muscular endurance [Months: 0, 2]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Saint-Etienne Saint-Étienne France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: David Hupin, MD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT05749744
Other Study ID Numbers:
  • IRBN1022021/CHUSTE
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2023