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

NCT06474624 | Completed

• 1 other identifier: 2023-08/01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Heart Disease; Quality of Life; Functional Capacity; Fatigue

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Fatigue Severity Scale

  10 weeks

• 36-Item Short Form Survey (SF-36)

  10 weeks

Study Arms (2)

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.

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.

Other: Cardio Rehabilitation program; Other: Cycling a total of 4 cycles

Interventions

Cardio Rehabilitation program OTHER

A total of 24 30 (8-10 weeks) sessions of an exercise-based Cardio Rehabilitation program 3 days a week.

High-intensity interval training; Moderate Intensity Continuous Training

Cycling for 20-30 minutes OTHER

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

Moderate Intensity Continuous Training

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.

High-intensity interval training

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

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

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Disease; Fatigue

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 25, 2024
• Study Start: May 26, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)