Clinical trial NCT06474624: Evaluation of the Effects of Training at Different Intensities in Coronary Artery Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Quality of Life
Functional Capacity
Fatigue
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Cardiopulmonary Exercise Test (CPET) - Heart Rate Recovery
timeFrame: 8 weeks
measure: Cardiopulmonary Exercise Test (CPET) - Functional Capacity
timeFrame: 8 weeks
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: 10 weeks
measure: 36-Item Short Form Survey (SF-36)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya University of Health Sciences Evliya Çelebi Physical Medicine and Rehabilitation Clinic, Cardiopulmonary Rehabilitation Unit
Study officials:
References: