Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model
| Registry | NCT04121702 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 90 (Estimated) |
| Sponsor | Juan Izquierdo García (Other) |
| Conditions | Acute Coronary Syndrome, Cardiac Rehabilitation, Telerehabilitation, Secondary Prevention, Wearable Electronic Devices, Exercise Therapy |
| Interventions | Cardiac Rehabilitation (Procedure) |
| Dates | start 2019-05-08, primary completion 2020-12-01 (estimated), completion 2020-12-01 (estimated), first posted 2019-10-10, last updated 2019-10-11 |
| Locations | 1 site in Spain |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PEP-H | Active comparator | Procedure: Cardiac Rehabilitation | Physical exercise program at a hospital |
| PEP-PSC | Experimental | Procedure: Cardiac Rehabilitation | Physical exercise program with tele-monitoring in a public sport centre |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |