Cardiovascular DiseasesNCT06071273
Online Platform for Self-service of Patients With Chronic Cardiovascular Diseases
A study testing Group A: online real-time home based exercise using the online platform and Group B: supervised community based exercise intervention in people with Cardiovascular Diseases, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 66 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Group A: online real-time home based exercise using the online platform and Group B: supervised community based exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 10 Oct 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cardiovascular disease and recent myocardial infarction (>4weeks)
- Patients shall be in a clinical stable condition.
Who cannot join
- Uncontrolled T1 or T2 diabetes mellitus.
- Comorbidities precluding exercise training (e.g., orthopaedic/neurological conditions).
- Uncontrolled arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Online Platform for Self-service of People Living With Chronic Cardiovascular Diseases
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
- Being tested
- Group A: online real-time home based exercise using the online platform, Group B: supervised community based exercise intervention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: online real-time home based exercise using the online platformOther
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.
Group B: supervised community based exercise interventionOther
Identical exercise program to Group A, the only difference is that Group performs the supervised exercise in community based health clubs/gyms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Group B: supervised community based exercise intervention |
| Control group | No intervention | Control group, no exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity levels
Physical activity levels will be assessed by mean daily step count for all groups including the control group.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start10 Oct 2023
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Kouidi, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071273
- Sponsor's protocol ID
- ΚΜΡ6-0076626
- Status last verified
- Jun 2024
- First submitted
- 2 Oct 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39350291
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Online Platform for Self-service of People Living With Chronic Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT06071273
- Acronym / sponsor ID
- ΚΜΡ6-0076626
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Home-based exercise | Experimental | Other: Group A: online real-time home based exercise using the online platform6 months home-based exercise program with continuous monitoring of the cardiovascular response of the participants during exercise via the online platform. |
| Community-based exercise | Experimental | Other: Group B: supervised community based exercise intervention6-month community based (i.e., local community gym) exercise intervention |
| Control group | No intervention | –Control group, no exercise intervention. |
Who may qualify
- Ages
- 40 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with cardiovascular disease and recent myocardial infarction (>4weeks)
- Patients shall be in a clinical stable condition.
Key exclusion criteria (3 listed)
- Uncontrolled T1 or T2 diabetes mellitus.
- Comorbidities precluding exercise training (e.g., orthopaedic/neurological conditions).
- Uncontrolled arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: online real-time home based exercise using the online platformPatients 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. | Other | Home-based exercise |
| Group B: supervised community based exercise interventionIdentical exercise program to Group A, the only difference is that Group performs the supervised exercise in community based health clubs/gyms. | Other | Community-based exercise |
Primary outcome
Physical activity levels
Time frame: 6 months
Physical activity levels will be assessed by mean daily step count for all groups including the control group.
3 secondary outcomes
Cardiorespiratory fitness (CRF)
Time frame: 6 months
Percentage of body fat mass
Time frame: 6 months
Body muscle mass
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 39350291Mitropoulos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: online real-time home based exercise using the online platform and Group B: supervised community based exercise intervention in people with Cardiovascular Diseases, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.