Online Platform for Self-service of Patients With Chronic Cardiovascular Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define the requirements and characteristics of the software that will be developed for the project Creation of a platform for self-service of people living with chronic cardiovascular diseases in an understandable, clear, complete, consistent and verifiable manner. The project concerns the design and implementation of a long-term program of therapeutic exercise and evaluation, by exercise and health professionals, of the anatomical and functional adaptations of exercise in patients and athletes with cardiovascular diseases. Essentially, it is a program of recording and monitoring cardiovascular rehabilitation in the form of systematic exercise of the patient both at home and in sports venues, which will contribute to the prevention of cardiovascular events in conditions of fatigue and at rest as well as to the gradual rehabilitation of the patient who performs a physical activity. Depending on the individual's functional capacity and health issues, combined with monitoring the patient's vital signs (such as blood pressure, heart rate, oxygen saturation, body temperature) the exercise professional will create an individualized, targeted exercise program with ultimate aiming at its rehabilitation with the help of physical activity and the improvement of its functional performance and by extension the quality of life of the individual. At the same time, the project will seek to motivate patients to remain committed to the physical activity program, with the aim of faster reintegration into their daily life.

Official Title
-----------------
Development of an Online Platform for Self-service of People Living With Chronic Cardiovascular Diseases

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: Group A: online real-time home based exercise using the online platform
* Other: Group B: supervised community based exercise intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cardiovascular disease and recent myocardial infarction (>4weeks) Patients shall be in a clinical stable condition. Exclusion Criteria: Uncontrolled T1 or T2 diabetes mellitus. Comorbidities precluding exercise training (e.g., orthopaedic/neurological conditions). Uncontrolled arrhythmias

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 66 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based exercise<br>6 months home-based exercise program with continuous monitoring of the cardiovascular response of the participants during exercise via the online platform. | Other: Group A: online real-time home based exercise using the online platform<br>* Patients that will be randomly assigned to this group will be exercising at home by providing data of their vital signs during exercise and at rest. To succeed this, they will be provided with the appropriate equipment (e.g., a smart watch able to assess the electrical signs of the heart (i.e., ECG) and heart rate, an automated blood pressure monitor, and an electrical body scale) which will be directly linked to the online platform. The online real-time supervised home-based exercise program is identical to Group B, the only difference is that it is performed at home. Each session has a duration of 60 minutes consisting of 40 mins of aerobic exercise and 20mins of resistance training. The overall intensity is kept to moderate based on ratings of perceived exertion (i.e., 13-14 in Borg's scale 6-20). The program will last for 6 months with exercise sessions taking place thrice per week.<br>|
| Experimental: Community-based exercise<br>6-month community based (i.e., local community gym) exercise intervention | Other: Group B: supervised community based exercise intervention<br>* Identical exercise program to Group A, the only difference is that Group performs the supervised exercise in community based health clubs/gyms.<br>|
| No Intervention: Control group<br>Control group, no exercise intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity levels | Physical activity levels will be assessed by mean daily step count for all groups including the control group. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory fitness (CRF) | CRF will be assessed by performing a peak oxygen uptake test at baseline and post-exercise intervention for all groups including the control group. | 6 months | 
| Percentage of body fat mass | Body composition analysis will be performed via bioelectrical impedance to assess the levels of fat (%) pre and the intervention for all groups, including the control group. | 6 months | 
| Body muscle mass | Body composition analysis will be performed via bioelectrical impedance to assess the levels of muscle mass (kg) pre and the intervention for all groups, including the control group. | 6 months |