Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center

Last updated: October 9, 2019
Sponsor: Juan Izquierdo García
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT04121702
e-CARCEX
  • Ages > 18
  • All Genders

Study Summary

The aim of this study is to establish an innovative Cardiac Tele-Rehabilitation (CTR) model. It could expands assistance resources through coordination with public administrations, developing a physical exercise program (PEP) assistance model in phase II that resolves the current situation of lack of adherence in the PEP due in part to the long waiting time to start it. To sum up this study could improve adherence in Cardiac Rehabilitation Phase III. It represents an opportunity to validate an innovative model for the realization of the PEP for phase II that could be expanded to other centres.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Recent ACS (1-12 months) of low / moderate risk for the realization of a PEP andwithout physical impediments for it

  • Availability of a mobile phone with Android operating system where you can install theS-PATCH3-Cardio application

  • Patients who recognize that they are trained to operate the S-PATCH3-Cardio deviceafter being instructed in its operation and perform a 24-hour simulation.

  • Signature of informed consent

Exclusion

Exclusion Criteria:

  • Baseline ergospirometry that does not reach maximalist criteria (respiratory quotient> 1.1)

  • Mental disability

  • Associated comorbidity that prevents performing PEP

Study Design

Total Participants: 90
Study Start date:
May 08, 2019
Estimated Completion Date:
December 31, 2020

Study Description

Cardiac Rehabilitation (CR) programs show benefits in cardiovascular morbidity and mortality, exercise capacity, risk factors and quality of life. The use of new information and communication technologies (ICT) allows remote monitoring of activity and rhythm, defining a new model of cardiac tele-rehabilitation (CTR) and proving to be safe.

The investigators intend to evaluate a new model of CR in Phase II in acute coronary syndrome (ACS), based on the implementation of the physical exercise program (PEP) in a public sports centre (PSC) with tele-monitoring by means of a wearable electronic device, S-PATCH3-Cardio, to compare the adherence of a PEP based on a CTR-PSC model with the traditional in-hospital program (PEP-H) maintaining the efficacy and safety of the CR program.

Patients with recent stratified ACS of low and / or moderate risk will be included who will be randomly assigned to the PEP-H group who will perform 18 PEP sessions with strength training and cardiorespiratory resistance in a hospital, or a CTR-PSC group that performs the 18 sessions of the PEP with strength training and cardiorespiratory resistance in the PSC.

All patients will perform the rest of the CR program at the hospital that it includes: functional tests, consultations with nurse, cardiologist, rehabilitation doctor, and the educational program, with 10 Workshops in a Cardio-healthy Classroom.

Connect with a study center

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.