Coronary Heart DiseaseNCT06474624
Evaluation of the Effects of Training at Different Intensities in Coronary Artery Patients
A study testing Cardio Rehabilitation program, Cycling for 20-30 minutes and Cycling a total of 4 cycles in people with Coronary Heart Disease and Quality of Life, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Coronary heart disease (CHD) remains the leading cause of morbidity and mortality in developed countries, accounting for approximately one-third of all deaths in individuals over 35 years of age. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Coronary Heart Disease, Quality of Life, Functional Capacity
- What is being tested?
- Cardio Rehabilitation program, Cycling for 20-30 minutes and Cycling a total of 4 cycles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 May 2023to 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 30 and 65,
- Being with stable New York Heart Association functional class I or II coronary artery disease with angina pectoris or myocardial infarction,
- Having a left ventricular ejection fraction of 40% or above,
- Being clinically stable for more than 2 weeks in terms of symptoms and medical treatment.
Who cannot join
- Symptoms of ischaemia,
- Being in Class III-IV according to the New York Heart Classification,
- Presence of significant left ventricular outflow obstruction,
- Ventricular arrhythmia,
- Significant valvular heart disease,
- Failure to comply with the rules of exercise testing and training,
Show all 14Show fewer
- Significant orthopaedic or neurological comorbidity preventing full participation.
- Less than 80% participation in the treatment programme
- Metabolic, haematological or other inflammatory diseases
- Known psychiatric illness
- Active malignancy and/or those diagnosed with malignancy within the last 5 years
- Those who have used tobacco products in the last 5 years
- BMI >35
- History of major orthopaedic surgery within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya University of Health Sciences Evliya Çelebi Physical Medicine and Rehabilitation Clinic, Cardiopulmonary Rehabilitation Unit
Kütahya
About this study
Official title: Evaluation of the Effects of High-Intensity-Intermittent Training and Moderate-Intensity Continuous Training on Heart Rate Recovery, Functional Capacity, Fatigue and Quality of Life in Coronary Artery Patients
Coronary heart disease (CHD) remains the leading cause of morbidity and mortality in developed countries, accounting for approximately one-third of all deaths in individuals over 35 years of age.
Despite research to date, the basis of the disease is still poorly understood, with chronic dysfunction of the autonomic nervous system being proposed as such a basis, as well as pathophysiological and pathogenic approaches. Hypertension has been implicated in the development of cardiovascular risk factors such as diabetes and dyslipidaemia and is directly linked to mortality caused by coronary artery disease.
Read more
Moderate Intensity Continuous Training (MICT) has been recognised as the gold standard for many years. However, for some time, different researchers have adopted the high-intensity interval training model (HIIT) as the most effective method in terms of objective adaptations of most cardiac rehabilitation programmes in patients with coronary artery disease (CAD) and congestive heart failure.
High-intensity interval training (HIIT) consists of cycles between warm-up and cool-down periods, high-intensity exercise intensity followed by an active recovery period. The duration and intensity of these cycles vary between studies and there is no consensus on which is the optimal cycle. In general, the high-intensity exercise phase is applied at 80-100% of VO2 max and the active recovery phase is used between 50-70% of VO2 max.
In Moderate Intensity Continuous Training the submaximal exercise intensity determined in accordance with the patient's functional capacity between the warm-up and cool-down periods is applied for a fixed period. The Moderate Intensity Continuous Training is planned to consist of 20-30 minute sessions between 50-70% of maximum oxygen consumption (VO2max).
- Conditions
- Coronary Heart Disease, Quality of Life, Functional Capacity, Fatigue
- Being tested
- Cardio Rehabilitation program, Cycling for 20-30 minutes, Cycling a total of 4 cycles
- Medical subject headings
- Coronary Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio Rehabilitation programOther
A total of 24 30 (8-10 weeks) sessions of an exercise-based Cardio Rehabilitation program 3 days a week.
Cycling for 20-30 minutesOther
Cycling for 20-30 minutes at 50-70% of Wmax between warm-up and cool-down periods.
Cycling a total of 4 cyclesOther
Cycling a total of 4 cycles consisting of 4 minutes at 85-100% of Wmax followed by 3 minutes of active recovery periods at 50-70% of Wmax between warm-up and cool-down periods.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Continuous Training | Experimental | * A total of 24 -30 (8-10 weeks) sessions of an exercise-based Cardio Rehabilitation program 3 days a week.
* Cycling for 20-30 minutes at 50-70% of Wmax between warm-up and cool-down periods. Receives: Other: Cardio Rehabilitation program; Other: Cycling for 20-30 minutes |
| High-intensity interval training | Experimental | * A total of 24 -30 (8-10 weeks) sessions of an exercise-based Cardiac Rehabilitation program 3 days a week.
* Cycling a total of 4 cycles consisting of 4 minutes at 85-100% of Wmax followed by 3 minutes of active recovery periods at 50-70% of Wmax between warm-up and cool-down periods. Receives: Other: Cardio Rehabilitation program; Other: Cycling a total of 4 cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Test (CPET) - Heart Rate Recovery
Cardiopulmonary exercise testing (CPET) is performed on patients with a bicycle ergometer, including analysis of exhaled gases. The testing protocol is tailored to the physical condition of each patient in gradual increments of 10, 15 or 20 W/min. The same protocol is used before and after the exercise training programme. The aim of exercise testing is to obtain a sustained effort for 8 to 12 minutes in order to maintain favourable oxygen uptake (VO2) kinetics and a linear relationship between VO2, exercise workload and heart rate (HR). A 12-lead ECG is continuously monitored and blood pressure is measured every 3 min during exercise tests. Resting heart rate, maximum heart rate, maximum load (watts), systolic blood pressure, diastolic blood pressure, VO2 max and/or VO2 estimate, HRR-1 and HRR-2 values are recorded before and after treatment as CPET data. HRR indices are calculated by subtracting the first and second-minute HR during the recovery period from the maximal HR.
Measured: 8 weeks
Cardiopulmonary Exercise Test (CPET) - Functional Capacity
Cardiopulmonary exercise testing (CPET) is performed on patients with a bicycle ergometer, including analysis of exhaled gases. The testing protocol is tailored to the physical condition of each patient in gradual increments of 10, 15 or 20 W/min. The same protocol is used before and after the exercise training programme. The aim of exercise testing is to obtain a sustained effort for 8 to 12 minutes in order to maintain favourable oxygen uptake (VO2) kinetics and a linear relationship between VO2, exercise workload and heart rate (HR). A 12-lead ECG is continuously monitored and blood pressure is measured every 3 min during exercise tests. Resting heart rate, maximum heart rate, maximum load (watts), systolic blood pressure, diastolic blood pressure, VO2 max and/or VO2 estimate, HRR-1 and HRR-2 values are recorded before and after treatment as CPET data. HRR indices are calculated by subtracting the first and second-minute HR during the recovery period from the maximal HR.
Measured: 8 weeks
Secondary outcomes (2)
Fatigue Severity Scale
In the scale consisting of nine items that patients can self-administer, each item is scored between 1-7 (1=strongly disagree, 7=strongly agree) and questions the fatigue status in the last month. The scale score is the average value of the questions. If the average score is 5 and above, it is considered as "there is fatigue". An increase in the scale score indicates an increase in the level of fatigue.
Measured: 10 weeks
36-Item Short Form Survey (SF-36)
It was developed by Ware et al. in 1992. The survey consists of a total of 36 questions with sub-headings such as function, role limitations related to physical health, role limitations related to emotional health, social function, mental health, energy, body pain, perception of general health and health change. The person can evaluate both negative and positive aspects of the health status. The total score varies between 0 and 100. A lower total score indicates a worse health status.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start26 May 2023
- 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 Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Yaman, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474624
- Sponsor's protocol ID
- 2023-08/01
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of High-Intensity-Intermittent Training and Moderate-Intensity Continuous Training on Heart Rate Recovery, Functional Capacity, Fatigue and Quality of Life in Coronary Artery Patients
- ClinicalTrials.gov ID
- NCT06474624
- Acronym / sponsor ID
- 2023-08/01
- Conditions
- Coronary Heart Disease, Quality of Life, Functional Capacity, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 25 Jun 2024 (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.
Coronary heart disease (CHD) remains the leading cause of morbidity and mortality in developed countries, accounting for approximately one-third of all deaths in individuals over 35 years of age.
Despite research to date, the basis of the disease is still poorly understood, with chronic dysfunction of the autonomic nervous system being proposed as such a basis, as well as pathophysiological and pathogenic approaches. Hypertension has been implicated in the development of cardiovascular risk factors such as diabetes and dyslipidaemia and is directly linked to mortality caused by coronary artery disease.
Moderate Intensity Continuous Training (MICT) has been recognised as the gold standard for many years. However, for some time, different researchers have adopted the high-intensity interval training model (HIIT) as the most effective method in terms of objective adaptations of most cardiac rehabilitation programmes in patients with coronary artery disease (CAD) and congestive heart failure.
High-intensity interval training (HIIT) consists of cycles between warm-up and cool-down periods, high-intensity exercise intensity followed by an active recovery period. The duration and intensity of these cycles vary between studies and there is no consensus on which is the optimal cycle. In general, the high-intensity exercise phase is applied at 80-100% of VO2 max and the active recovery phase is used between 50-70% of VO2 max.
In Moderate Intensity Continuous Training the submaximal exercise intensity determined in accordance with the patient's functional capacity between the warm-up and cool-down periods is applied for a fixed period. The Moderate Intensity Continuous Training is planned to consist of 20-30 minute sessions between 50-70% of maximum oxygen consumption (VO2max).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Continuous Training | Experimental | Other: Cardio Rehabilitation program, Other: Cycling for 20-30 minutes* A total of 24 -30 (8-10 weeks) sessions of an exercise-based Cardio Rehabilitation program 3 days a week. * Cycling for 20-30 minutes at 50-70% of Wmax between warm-up and cool-down periods. |
| High-intensity interval training | Experimental | Other: Cardio Rehabilitation program, Other: Cycling a total of 4 cycles* A total of 24 -30 (8-10 weeks) sessions of an exercise-based Cardiac Rehabilitation program 3 days a week. * Cycling a total of 4 cycles consisting of 4 minutes at 85-100% of Wmax followed by 3 minutes of active recovery periods at 50-70% of Wmax between warm-up and cool-down periods. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 30 and 65,
- Being with stable New York Heart Association functional class I or II coronary artery disease with angina pectoris or myocardial infarction,
- Having a left ventricular ejection fraction of 40% or above,
- Being clinically stable for more than 2 weeks in terms of symptoms and medical treatment.
Key exclusion criteria (14 listed)
- Symptoms of ischaemia,
- Being in Class III-IV according to the New York Heart Classification,
- Presence of significant left ventricular outflow obstruction,
- Ventricular arrhythmia,
- Significant valvular heart disease,
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 |
|---|---|---|
| Cardio Rehabilitation programA total of 24 30 (8-10 weeks) sessions of an exercise-based Cardio Rehabilitation program 3 days a week. | Other | High-intensity interval training, Moderate Intensity Continuous Training |
| Cycling for 20-30 minutesCycling for 20-30 minutes at 50-70% of Wmax between warm-up and cool-down periods. | Other | Moderate Intensity Continuous Training |
| Cycling a total of 4 cyclesCycling a total of 4 cycles consisting of 4 minutes at 85-100% of Wmax followed by 3 minutes of active recovery periods at 50-70% of Wmax between warm-up and cool-down periods. | Other | High-intensity interval training |
Primary outcome
Cardiopulmonary Exercise Test (CPET) - Heart Rate Recovery
Time frame: 8 weeks
Cardiopulmonary exercise testing (CPET) is performed on patients with a bicycle ergometer, including analysis of exhaled gases. The testing protocol is tailored to the physical condition of each patient in gradual increments of 10, 15 or 20 W/min. The same protocol is used before and after the exercise training programme. The aim of exercise testing is to obtain a sustained effort for 8 to 12 minutes in order to maintain favourable oxygen uptake (VO2) kinetics and a linear relationship between VO2, exercise workload and heart rate (HR). A 12-lead ECG is continuously monitored and blood pressure is measured every 3 min during exercise tests. Resting heart rate, maximum heart rate, maximum load (watts), systolic blood pressure, diastolic blood pressure, VO2 max and/or VO2 estimate, HRR-1 and HRR-2 values are recorded before and after treatment as CPET data. HRR indices are calculated by subtracting the first and second-minute HR during the recovery period from the maximal HR.
Cardiopulmonary Exercise Test (CPET) - Functional Capacity
Time frame: 8 weeks
Cardiopulmonary exercise testing (CPET) is performed on patients with a bicycle ergometer, including analysis of exhaled gases. The testing protocol is tailored to the physical condition of each patient in gradual increments of 10, 15 or 20 W/min. The same protocol is used before and after the exercise training programme. The aim of exercise testing is to obtain a sustained effort for 8 to 12 minutes in order to maintain favourable oxygen uptake (VO2) kinetics and a linear relationship between VO2, exercise workload and heart rate (HR). A 12-lead ECG is continuously monitored and blood pressure is measured every 3 min during exercise tests. Resting heart rate, maximum heart rate, maximum load (watts), systolic blood pressure, diastolic blood pressure, VO2 max and/or VO2 estimate, HRR-1 and HRR-2 values are recorded before and after treatment as CPET data. HRR indices are calculated by subtracting the first and second-minute HR during the recovery period from the maximal HR.
2 secondary outcomes
Fatigue Severity Scale
Time frame: 10 weeks
36-Item Short Form Survey (SF-36)
Time frame: 10 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 27 Jun 2024.
- 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 Cardio Rehabilitation program, Cycling for 20-30 minutes and Cycling a total of 4 cycles in people with Coronary Heart Disease and Quality of Life, run by Kutahya Health Sciences 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 14 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 27 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?
Cardiopulmonary Exercise Test (CPET) - Heart Rate Recovery (time frame: 8 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 27 Jun 2024.