Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-08

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome Cardiac Rehabilitation Telerehabilitation Secondary Prevention Wearable Electronic Devices Exercise Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PEP-H

Physical exercise program at a hospital

Group Type ACTIVE_COMPARATOR

Cardiac Rehabilitation

Intervention Type PROCEDURE

Implementation of a physical exercise program (PEP) with tele-monitoring

PEP-PSC

Physical exercise program with tele-monitoring in a public sport centre

Group Type EXPERIMENTAL

Cardiac Rehabilitation

Intervention Type PROCEDURE

Implementation of a physical exercise program (PEP) with tele-monitoring

Interventions

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Cardiac Rehabilitation

Implementation of a physical exercise program (PEP) with tele-monitoring

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Recent ACS (1-12 months) of low / moderate risk for the realization of a PEP and without physical impediments for it
* Availability of a mobile phone with Android operating system where you can install the S-PATCH3-Cardio application
* Patients who recognize that they are trained to operate the S-PATCH3-Cardio device after being instructed in its operation and perform a 24-hour simulation.
* Signature of informed consent

Exclusion Criteria

* Baseline ergospirometry that does not reach maximalist criteria (respiratory quotient\> 1.1)
* Mental disability
* Associated comorbidity that prevents performing PEP

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No