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NCT Number: NCT06474624

Evaluation of the Effects of Training at Different Intensities 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.

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).

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Fatigue Functional Capacity Heart Diseases Myocardial Ischemia Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya University of Health Sciences Evliya Çelebi Physical Medicine and Rehabilitation Clinic, Cardiopulmonary Rehabilitation Unit

Kütahya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • 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.

Treatment and study plan

Cardio Rehabilitation program

Other

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

Other

Cycling for 20-30 minutes at 50-70% of Wmax between warm-up and cool-down periods.

Cycling a total of 4 cycles

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Fatigue Severity Scale

    Time frame: 10 weeks

    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.

  2. 36-Item Short Form Survey (SF-36)

    Time frame: 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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