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

NCT ID: NCT06474624

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-26
• Study Completion Date: 2024-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cardio Rehabilitation program

Intervention Type: 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

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Cardio Rehabilitation program

Intervention Type: OTHER

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

Cycling a total of 4 cycles

Intervention Type: 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.

Interventions

Cardio Rehabilitation program

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

Intervention Type: OTHER

Cycling for 20-30 minutes

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

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kutahya Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Fatima Yaman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Kütahya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023-08/01

Identifier Type: -

Identifier Source: org_study_id