Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center

Not Applicable

• Conditions: Acute Coronary Syndrome; Telerehabilitation; Exercise Therapy; Secondary Prevention; Cardiac Rehabilitation; Wearable Electronic Devices
• Interventions: Procedure: Cardiac Rehabilitation

• Registration Number: NCT04121702
• Lead Sponsor: Juan Izquierdo García

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.

Study Timeline

• Study Start: 2019-05-08
• Study First Submitted: 2019-06-17
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-11
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEP-PSC	Cardiac Rehabilitation	Physical exercise program with tele-monitoring in a public sport centre
PEP-H	Cardiac Rehabilitation	Physical exercise program at a hospital

Primary Outcome Measures

Name	Time	Method
Functional capacity	At the end of the program (6 weeks)	Change of functional capacity measured by cardiopulmonary exercise test
Adherence to physical exercise	At the end of the program (6 weeks)	Adherence to physical exercise measured by number of physical exercise sessions realized by each patient

Secondary Outcome Measures

Name	Time	Method
Blood pressure levels	At the end of the program (6 weeks)	Evaluate changes on systolic and diastolic blood pressure levels (mmHg)
Weight	At the end of the program (6 weeks)	Evaluate changes on weight (kg)
Adherence to Mediterranean Diet	At the end of the program (6 weeks)	Evaluate changes on mediterranean dietary habits measured ussing the Mediterranean Diet Assessment Scale (MEDAS) which is constituted by 14 ítems with questions concerning dietary habits related to the medditerranean dietary style. Minimum score: 0, maximum score: 14. Values over 9 are corresponded to good adherence to mediterranean diet, values under 9 are considered to be bad adherence.
Glycated hemoglobin levels (HbA1c)	At the end of the program (6 weeks)	Evaluate changes on the glycated hemoglobin (mg/dL)
Glucose levels	At the end of the program (6 weeks)	Evaluate changes on the glucose metabolic profile (mg/dL)
Low-density lipoprotein (LDL) levels	At the end of the program (6 weeks)	Evaluate changes on the LDL metabolic profile (mg/dL)
Body Mass Index (BMI)	At the end of the program (6 weeks)	Evaluate changes on body mass index (weight in kg and height in meters will be combined to calculate BMI in kg/m˄2)
High-density lipoprotein (HDL) levels	At the end of the program (6 weeks)	Evaluate changes on the HDL metabolic profile (mg/dL)
Total colesterol levels	At the end of the program (6 weeks)	Evaluate changes on the total colesterol metabolic profile (mg/dL)
Smoking	At the end of the program (6 weeks)	Evaluate changes on smoking status (cessation of smoking)
Abdominal perimeter	At the end of the program (6 weeks)	Evaluate changes on abdominal perimeter (cm)
Phisical exercise profile	At the end of the program (6 weeks)	Evaluate changes on level of physical activity measured ussing the International Physical Activity Questionnaire (IPAQ). It asks about three specific types of activity undertaken in the four domains: leisure time physical activity, domestic and gardening (yard) activities, work-related physical activity, transport-related physical activity. The specific types of activity that are assessed are walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.; Maximun value: the sum total of all Walking, Moderate and Vigorous time variables greater than 960 minutes (16 hours).; Mínimum value: Only values of 10 or more minutes of activity should be included in the calculation of summary scores. Responses of less than 10 minutes \[and their associated days\] should be re-coded to 'zero'

Trial Locations

Locations (1)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain