Coronary Artery DiseaseNCT05264701
Investigation of the Effects of the Technology-based Cardiac Rehabilitation Program in Coronary Artery Patients
A study testing Physiotherapist supervised exercise training, Exercise training via phone app and Physical activity recommendations in people with Coronary Artery Disease and Physical Inactivity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Physical Inactivity
- What is being tested?
- Physiotherapist supervised exercise training, Exercise training via phone app and Physical activity recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2022to 1 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary artery disease
- Access to the online program
- Volunteering to participate in the research
- Having an iOS or Android operating system compatible phone
Who cannot join
- Having a musculoskeletal problem
- Having uncontrolled hypertension
- Having chronic heart failure (NYHA III-IV)
- A history of acute coronary syndrome or surgical revascularization less than 12 months ago
- More than 50% occlusion on the main coronary artery
- Having arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Artificial Intelligence-supported and Technology-based Cardiac Rehabilitation Programs on Participation and Exercise Capacity in Coronary Artery Patients
This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.
Read the detailed description
Cardiovascular diseases constitute one of the most critical health problems of today's society due to the loss of workforce, morbidity, mortality, and high hospital expenses.
This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.
- Conditions
- Coronary Artery Disease, Physical Inactivity
- Being tested
- Physiotherapist supervised exercise training, Exercise training via phone app, Physical activity recommendations
- Keywords
- Cardiac Rehabilitation, Exercise Training
- Medical subject headings
- Coronary Artery Disease, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist supervised exercise trainingOther
Exercise training for 12 weeks will be given by video talk accompanied by a physiotherapist.
Exercise training via phone appOther
Exercise training for 12 weeks will be given over the developed phone application.
Physical activity recommendationsOther
The program will be consist of 12 weeks of physical activity recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapist Supervised Exercise Training Group | Experimental | Physiotherapist supervised exercise training in patients with coronary artery disease Receives: Other: Physiotherapist supervised exercise training |
| Exercise Training Tracking from Phone-app Group | Experimental | Exercise training tracking from phone app in patients with coronary artery disease Receives: Other: Exercise training via phone app |
| Control Group | Experimental | General physical activity recommendations for home Receives: Other: Physical activity recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Exercise capacity will be evaluated using the incremental shuttle walk test.
Measured: Baseline, after 12 weeks, after 24 weeks
Participation
Participation will be evaluated using the number of sessions attended.
Measured: after 12 weeks
Secondary outcomes (6)
Maximal Effort Capacity
Maximal effort capacity will be evaluated using a cardiovascular stress test.
Measured: Baseline
Peripheral muscle strength
Peripheral muscle strength will be evaluated using the dynamometer.
Measured: Baseline, after 12 weeks, after 24 weeks
Endothelial function
The endothelial function will be evaluated using echocardiography. After a resting baseline, Brachial artery diameter will be recorded, the cuff used in blood pressure measurement will be inflated 25-50 mmHg above the systolic blood pressure value and maintain that pressure for 5 min. The brachial artery diameter will be measured again after the cuff is deflated.
Measured: Baseline, after 12 weeks, after 24 weeks
Healthy Living Habit Evaluation
Healthy living habit evaluation will be evaluated using the Healthy Lifestyle Behaviors Scale-II.
Measured: Baseline, after 12 weeks, after 24 weeks
Health-Related Quality of Life
Health-Related Quality of Life will be evaluated using the Myocardial Infarction Dimensional Assessment Scale (MIDAS).
Measured: Baseline, after 12 weeks, after 24 weeks
QoL
Quality of life will be evaluated using the SF-36 Short Form.
Measured: Baseline, after 12 weeks, after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start7 Apr 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Saklica, Hacettepe University
- Investigators
- Naciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityHikmet Yorgun, PhD, Study director, Hacettepe UniversityAhmet Hakan Ates, PhD, Study chair, Hacettepe UniversityDeniz Yuce, PhD, Study chair, Hacettepe UniversityDilara Saklica, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264701
- Sponsor's protocol ID
- KA-20105
- Status last verified
- Jun 2024
- First submitted
- 19 Feb 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Artificial Intelligence-supported and Technology-based Cardiac Rehabilitation Programs on Participation and Exercise Capacity in Coronary Artery Patients
- ClinicalTrials.gov ID
- NCT05264701
- Acronym / sponsor ID
- KA-20105
- Conditions
- Coronary Artery Disease, Physical Inactivity
- Keywords
- Cardiac Rehabilitation, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 3 Mar 2022 (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.
This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.
Detailed description
Cardiovascular diseases constitute one of the most critical health problems of today's society due to the loss of workforce, morbidity, mortality, and high hospital expenses.
This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist Supervised Exercise Training Group | Experimental | Other: Physiotherapist supervised exercise trainingPhysiotherapist supervised exercise training in patients with coronary artery disease |
| Exercise Training Tracking from Phone-app Group | Experimental | Other: Exercise training via phone appExercise training tracking from phone app in patients with coronary artery disease |
| Control Group | Experimental | Other: Physical activity recommendationsGeneral physical activity recommendations for home |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with coronary artery disease
- Access to the online program
- Volunteering to participate in the research
- Having an iOS or Android operating system compatible phone
Key exclusion criteria (6 listed)
- Having a musculoskeletal problem
- Having uncontrolled hypertension
- Having chronic heart failure (NYHA III-IV)
- A history of acute coronary syndrome or surgical revascularization less than 12 months ago
- More than 50% occlusion on the main coronary artery
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 |
|---|---|---|
| Physiotherapist supervised exercise trainingExercise training for 12 weeks will be given by video talk accompanied by a physiotherapist. | Other | Physiotherapist Supervised Exercise Training Group |
| Exercise training via phone appExercise training for 12 weeks will be given over the developed phone application. | Other | Exercise Training Tracking from Phone-app Group |
| Physical activity recommendationsThe program will be consist of 12 weeks of physical activity recommendations. | Other | Control Group |
Primary outcome
Exercise Capacity
Time frame: Baseline, after 12 weeks, after 24 weeks
Exercise capacity will be evaluated using the incremental shuttle walk test.
Participation
Time frame: after 12 weeks
Participation will be evaluated using the number of sessions attended.
6 secondary outcomes
Maximal Effort Capacity
Time frame: Baseline
Peripheral muscle strength
Time frame: Baseline, after 12 weeks, after 24 weeks
Endothelial function
Time frame: Baseline, after 12 weeks, after 24 weeks
Healthy Living Habit Evaluation
Time frame: Baseline, after 12 weeks, after 24 weeks
Health-Related Quality of Life
Time frame: Baseline, after 12 weeks, after 24 weeks
QoL
Time frame: Baseline, after 12 weeks, after 24 weeks
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 18 Jun 2024.
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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.
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Hikmet Yorgun, PhD study director
Hacettepe University
Ahmet Hakan Ates, PhD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist supervised exercise training, Exercise training via phone app and Physical activity recommendations in people with Coronary Artery Disease and Physical Inactivity, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 18 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 Turkey (Türkiye). 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?
Exercise Capacity (time frame: Baseline, after 12 weeks, after 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2024.