Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center

Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome; Telerehabilitation; Cardiac Rehabilitation; Exercise Therapy; Secondary Prevention; Wearable Electronic Devices
• Intervention / Treatment: Procedure: Cardiac Rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Juan Izquierdo Garcia, Therapist; Phone Number: +34917792077; Email: juan.izquierdo@salud.madrid.org
    • Contact: Guillermo Moreno Muñoz, Nurse; Phone Number: +34913908519; Email: guimoren@ucm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEP-H; Physical exercise program at a hospital	Procedure: Cardiac Rehabilitation; Implementation of a physical exercise program (PEP) with tele-monitoring
Experimental: PEP-PSC; Physical exercise program with tele-monitoring in a public sport centre	Procedure: Cardiac Rehabilitation; Implementation of a physical exercise program (PEP) with tele-monitoring

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose levels	Evaluate changes on the glucose metabolic profile (mg/dL)	At the end of the program (6 weeks)
Glycated hemoglobin levels (HbA1c)	Evaluate changes on the glycated hemoglobin (mg/dL)	At the end of the program (6 weeks)
Low-density lipoprotein (LDL) levels	Evaluate changes on the LDL metabolic profile (mg/dL)	At the end of the program (6 weeks)
High-density lipoprotein (HDL) levels	Evaluate changes on the HDL metabolic profile (mg/dL)	At the end of the program (6 weeks)
Total colesterol levels	Evaluate changes on the total colesterol metabolic profile (mg/dL)	At the end of the program (6 weeks)
Blood pressure levels	Evaluate changes on systolic and diastolic blood pressure levels (mmHg)	At the end of the program (6 weeks)
Smoking	Evaluate changes on smoking status (cessation of smoking)	At the end of the program (6 weeks)
Weight	Evaluate changes on weight (kg)	At the end of the program (6 weeks)
Abdominal perimeter	Evaluate changes on abdominal perimeter (cm)	At the end of the program (6 weeks)
Body Mass Index (BMI)	Evaluate changes on body mass index (weight in kg and height in meters will be combined to calculate BMI in kg/m˄2)	At the end of the program (6 weeks)
Adherence to Mediterranean Diet	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.	At the end of the program (6 weeks)
Phisical exercise profile	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'	At the end of the program (6 weeks)

Collaborators and Investigators

• Sponsor: Juan Izquierdo García
• Investigators: Principal Investigator: Juan Izquierdo Garcia, Therapist, Hospital Universitario 12 de Octubre

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Telerehabilitation; Cardiac Rehabilitation; Exercise Therapy; Wearable Electronic Devices; Secondary Prevention
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: e-CARCEX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No