Trials / Unknown
UnknownNCT04121702
Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center
Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Juan Izquierdo García · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Acute Coronary Syndrome
- Cardiac Rehabilitation
- Telerehabilitation
- Secondary Prevention
- Wearable Electronic Devices
- Exercise Therapy
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cardiac Rehabilitation | Implementation of a physical exercise program (PEP) with tele-monitoring |
Timeline
- Start date
- 2019-05-08
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2019-10-10
- Last updated
- 2019-10-11
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04121702. Inclusion in this directory is not an endorsement.