Evaluation of the Effects of Training at Different Intensities in Coronary Artery Patients

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.

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 Overview

• Status: Completed
• Conditions: Quality of Life; Fatigue; Coronary Heart Disease; Functional Capacity
• Intervention / Treatment: Other: Cardio Rehabilitation program; Other: Cycling for 20-30 minutes; Other: Cycling a total of 4 cycles

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Intensity Continuous Training; 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.	Other: Cardio Rehabilitation program; A total of 24 30 (8-10 weeks) sessions of an exercise-based Cardio Rehabilitation program 3 days a week.; Other: Cycling for 20-30 minutes; Cycling for 20-30 minutes at 50-70% of Wmax between warm-up and cool-down periods.
Experimental: High-intensity interval training; 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.	Other: Cardio Rehabilitation program; A total of 24 30 (8-10 weeks) sessions of an exercise-based Cardio Rehabilitation program 3 days a week.; Other: Cycling a total of 4 cycles; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	10 weeks

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Fatigue
• Other Study ID Numbers: 2023-08/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No