NCT05749744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Last Updated

March 3, 2023

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

February 27, 2023

Last Update Submit

March 1, 2023

Conditions

Keywords

cardiac telerehabilitationacute coronary syndromerehabilitation therapeuticrehabilitation sessionscardiorespiratory functions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • oxygen (VO2) peak

    Months: 0, 2

  • maximum power workload

    Months: 0, 2

  • power at the first ventilatory threshold (VT1)

    Months: 0, 2

  • maximum heart rate

    Months: 0, 2

  • recovery heart rate

    Months: 0, 2

  • +4 more secondary outcomes

Study Arms (2)

Home-based cardiac telerehabilitation (interventional group)

Patients followed the cardiac rehabilitation program at home.

Other: cardiac telerehabilitation program by videoconference

Traditional centre-based cardiac rehabilitation (control group)

Patients participates in the cardiac rehabilitation program in hospital.

Interventions

* 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

Home-based cardiac telerehabilitation (interventional group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Both groups:
  • Pulmonary hypertension
  • Aortic pathway anomaly
  • Uncontrolled ventricular rhythm disorders
  • For Telerehabilitation group:
  • Important muscular deconditioning
  • Patient requiring medical supervision in institute

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Heart DiseasesAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesMyocardial IschemiaVascular Diseases

Study Officials

  • David Hupin, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 1, 2023

Study Start

March 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 3, 2023

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations