Clinical trial NCT04121702: Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center
Official title: Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Cardiac Rehabilitation
Telerehabilitation
Secondary Prevention
Wearable Electronic Devices
Exercise Therapy
Keywords: Cardiac Rehabilitation
Telerehabilitation
Secondary Prevention
Wearable Electronic Devices
Exercise Therapy
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to physical exercise
timeFrame: At the end of the program (6 weeks)
measure: Functional capacity
timeFrame: At the end of the program (6 weeks)
Secondary outcomes:
measure: Glucose levels
timeFrame: At the end of the program (6 weeks)
measure: Glycated hemoglobin levels (HbA1c)
timeFrame: At the end of the program (6 weeks)
measure: Low-density lipoprotein (LDL) levels
timeFrame: At the end of the program (6 weeks)
measure: High-density lipoprotein (HDL) levels
timeFrame: At the end of the program (6 weeks)
measure: Total colesterol levels
timeFrame: At the end of the program (6 weeks)
measure: Blood pressure levels
timeFrame: At the end of the program (6 weeks)
measure: Smoking
timeFrame: At the end of the program (6 weeks)
measure: Weight
timeFrame: At the end of the program (6 weeks)
measure: Abdominal perimeter
timeFrame: At the end of the program (6 weeks)
measure: Body Mass Index (BMI)
timeFrame: At the end of the program (6 weeks)
measure: Adherence to Mediterranean Diet
timeFrame: At the end of the program (6 weeks)
measure: Phisical exercise profile
timeFrame: At the end of the program (6 weeks)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Juan Izquierdo Garcia, Therapist
role: PRINCIPAL_INVESTIGATOR
References: