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

NCT06071273 | Completed

• 1 other identifier: ΚΜΡ6-0076626
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Physical activity levels

  Physical activity levels will be assessed by mean daily step count for all groups including the control group.

  6 months

Secondary Outcomes (3)

• Cardiorespiratory fitness (CRF)

  6 months

• Percentage of body fat mass

  6 months

• Body muscle mass

  6 months

Study Arms (3)

Home-based exercise

EXPERIMENTAL

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

Community-based exercise

EXPERIMENTAL

6-month community based (i.e., local community gym) exercise intervention

Other: Group B: supervised community based exercise intervention

Control group

NO INTERVENTION

Control group, no exercise intervention.

Interventions

Group A: online real-time home based exercise using the online platform OTHER

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.

Home-based exercise

Group B: supervised community based exercise intervention OTHER

Identical exercise program to Group A, the only difference is that Group performs the supervised exercise in community based health clubs/gyms.

Community-based exercise

Eligibility Criteria

• Age: 40 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cardiovascular disease and recent myocardial infarction (\>4weeks)
• Patients shall be in a clinical stable condition.

You may not qualify if:

• Uncontrolled T1 or T2 diabetes mellitus.
• Comorbidities precluding exercise training (e.g., orthopaedic/neurological conditions).
• Uncontrolled arrhythmias

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Thermi, 57001, Greece

Location

Related Publications (1)

• Mitropoulos A, Anifanti Mu, Koukouvou G, Ntovoli Alpha, Alexandris K, Kouidi E. Exploring the feasibility, acceptability, and safety of a real-time cardiac telerehabilitation and tele coaching programme using wearable devices in people with a recent myocardial infarction. BMC Sports Sci Med Rehabil. 2024 Sep 30;16(1):207. doi: 10.1186/s13102-024-00992-5.

  PMID: 39350291 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: October 10, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)