NCT Number: NCT07148518
Coronary artery disease (CAD) significantly increases mortality rates in both developed and developing countries. In this condition, the impairment of arterial blood circulation leads to insufficient blood supply to the myocardium during both rest and exercise, resulting in symptoms such as angina pectoris, dyspnea, and fatigue. Patients, particularly due to their fear of experiencing angina pectoris, tend to adopt a sedentary lifestyle. This situation contributes to exercise intolerance and a reduction in exercise capacity among individuals with CAD. A review of the literature reveals a lack of studies investigating upper and lower extremity exercise capacity and the physiological responses during exercise testing in patients with CAD. Therefore, the aim of this study is to compare arterial stiffness, muscle oxygenation, respiratory muscle fatigue, energy expenditure, perceived dyspnea, and fatigue during upper and lower extremity exercise testing in patients with coronary artery disease.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Ankara, Çankaya, 06490, Turkey (Türkiye)
Location status: Recruiting
Meral BOŞNAK GÜÇLÜ, Prof. Dr.
CONTACT
Naciye SEVİM, Pt.
CONTACT
As a consequence of atherosclerosis progresses with aging, the lumen of the arteries narrows and the arterial wall thickens. In patients with coronary artery disease, this process impairs arterial blood flow, resulting in insufficient blood supply to the myocardium. Consequently, due to the inability to meet the oxygen demands of the heart muscle both at rest and during exercise, patients experience symptoms such as angina pectoris, dyspnea, and fatigue. Particularly, fear of developing angina pectoris during physical activity leads patients to develop kinesiophobia and adopt a sedentary lifestyle. This condition further reduces their exercise capacity. In the literature, several studies have assessed the exercise capacity of these patients; however, these studies have predominantly utilized treadmill or cycle ergometers to evaluate lower extremity exercise capacity, and no study has been found that specifically investigates upper extremity exercise capacity. Considering that the upper extremities are used more frequently than the lower extremities during daily living activities, it is of particular importance to evaluate the upper extremity exercise capacity of patients. Moreover, upper extremity exercise testing provides an alternative means of assessment for patients with coronary artery disease who are unable to participate in lower extremity exercise tests due to neurological, vascular, or orthopedic problems. Compared to the lower extremities, the active muscle groups engaged during upper extremity exercise testing are smaller, which leads to lower metabolic demand and reduced peak oxygen consumption. This results in a lower cardiopulmonary workload during the exercise test. Therefore, it is necessary to investigate and compare upper and lower extremity exercise capacities, as well as the physiological responses elicited during exercise testing, in patients with coronary artery disease.
The primary aim of the study is to compare upper and lower extremity exercise capacities and arterial stiffness levels during exercise testing in patients with coronary artery disease.
The secondary aim of the study is to evaluate muscle oxygenation, energy expenditure, and the perception of dyspnea and fatigue during upper and lower extremity exercise testing in patients with coronary artery disease.
The primary outcomes are upper and lower maximal exercise capacities (Cardiopulmonary exercise tests) and arterial stiffness during cardiopulmonary exercise tests (Arteriograph) device).
Secondary outcomes are muscle oxygenation (Near-infrared spectroscopy) device, respiratory muscle fatigue (mouth pressure device), energy consumption (multi sensor activity device), the perception of dyspnea (Modified Borg Scale (MBS)) and fatigue (MBS).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through study completion, an average of 1 year
Maximal Exercise capacity will be evaluated with Cardiopulmonary Exercise testing. The Cardiopulmonary Exercise Testing will be applied according to American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Time frame: Through study completion, an average of 1 year
Arterial stiffness will be non-invasively evaluated with using the SphygmoCor XCEL® device, which has established validity and reliability. The device will measure carotid-femoral pulse wave velocity (PWV) along with pulse values.
Time frame: Through study completion, an average of 1 year
Arterial stiffness will be non-invasively evaluated with using the SphygmoCor XCEL® device, which has established validity and reliability. The device will measure augmentation index (AIx) along with pulse values.
Time frame: Through study completion, an average of 1 year
Peripheral muscle oxygen will be measured by near-infrared spectrometry. The device probes will be placed on the upper, lower extremities and trunk for both tests. The device allows to display of the percentage of oxygen, the concentration of oxyhemoglobin, and deoxyhemoglobin, the difference between oxyhemoglobin and deoxyhemoglobin, and the total hemoglobin. These parameters will be evaluated in our study.
Time frame: Through study completion, an average of 1 year
Energy consumption will be evaluated with the Multi sensor activity monitor. The patient wear the multi sensor physical activity monitor over the triceps muscle of the non-dominant arm during CPETs. Energy consumption (joule / day) will be measured with the multi-sensor physical activity monitor.
Time frame: Through study completion, an average of 1 year
Isometric peripheral muscle strength will be measured with a portable hand dynamometer. Measurements will be repeated on the shoulder abductors and knee extensors three times on the right and left.
Time frame: Through study completion, an average of 1 year
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were measured using a portable mouth pressure measuring device according to ATS and ERS criteria.
Time frame: Through study completion, an average of 1 year
Respiratory muscle fatigue in patients will be assessed both before and immediately after upper and lower extremity cardiopulmonary exercise testing by measuring maximal inspiratory pressure (MIP) using a mouth pressure measurement device in accordance with ATS/ERS criteria. Prior to the tests, measurements will be repeated at least five times until the difference between the two highest MIP values is less than 5% or 5 cmH₂O. Immediately after the tests, at least three measurements will be performed until the difference between the two best MIP values is less than 5% or 5 cmH₂O.
Time frame: Through study completion, an average of 1 year
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced vital capacity (FVC)was evaluated.
Time frame: Through study completion, an average of 1 year
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced expiratory volume in first second (FEV1) was evaluated.
Time frame: Through study completion, an average of 1 year
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, FEV1/FVC was evaluated.
Time frame: Through study completion, an average of 1 year
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, Flow rate 25-75% of forced expiratory volume (FEF25-75%)was evaluated.
Time frame: Through study completion, an average of 1 year
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, peak flow rate (PEF) was evaluated.
Time frame: Through study completion, an average of 1 year
Physical activity will be evaluated with the Multi sensor activity monitor. The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Physical activity level will be measured with the multi-sensor physical activity monitor.
Time frame: Through study completion, an average of 1 year
Chronotropic response assessment will be evaluated through exercise testing using the chronotropic index, which is calculated based on the maximal heart rate achieved during the exercise test and the resting heart rate.
Time frame: Through study completion, an average of 1 year
Dyspnea perception will be evaluated with Modified Borg Scale. The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means shortness of breath.
Time frame: Through study completion, an average of 1 year
Fatigue perception will be evaluated with Modified Borg Scale. The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means fatigue.
Contact information is provided by the study sponsor or research team.
Meral BOŞNAK GÜÇLÜ, Prof. Dr.
CONTACT
Naciye SEVİM, Pt.
CONTACT
Gazi University
Other
Comparison of Upper and Lower Limb Maximal Exercise Capacities, Arterial Stiffness, Muscle Oxygenation and Energy Consumption During Tests in Patients With Coronary Artery Disease
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