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

NCT ID: NCT06071273

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-05-30

Brief Summary

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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

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Home-based exercise

6 months home-based exercise program with continuous monitoring of the cardiovascular response of the participants during exercise via the online platform.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Community-based exercise

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

Group Type EXPERIMENTAL

Group B: supervised community based exercise intervention

Intervention Type OTHER

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

Control group

Control group, no exercise intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type OTHER

Group B: supervised community based exercise intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Evangelia Kouidi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aristotle University of Thessaloniki

Thessaloniki, Thermi, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 39350291 (View on PubMed)

Other Identifiers

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ΚΜΡ6-0076626

Identifier Type: -

Identifier Source: org_study_id

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