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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06071273
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-06
• Study Start: 2023-10-10
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-23
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical activity levels	6 months	Physical activity levels will be assessed by mean daily step count for all groups including the control group.

Secondary Outcome Measures

Name	Time	Method
Cardiorespiratory fitness (CRF)	6 months	CRF will be assessed by performing a peak oxygen uptake test at baseline and post-exercise intervention for all groups including the control group.
Percentage of body fat mass	6 months	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.
Body muscle mass	6 months	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.

Trial Locations

Locations (1)

Aristotle University of Thessaloniki; 🇬🇷 Thessaloníki, Thermi, Greece