An observational study in Coronary Artery Disease (CAD), sponsored by Gazi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Gazi University · Observational
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.
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).
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 30 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
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30 patients diagnosed with coronary artery disease will be recruited.
Exclusion Criteria:
The first test is the cardiopulmonary exercise test (CPET), which evaluates the maximal exercise capacity of the lower extremities and will be performed on a treadmill. During the test, the muscle oxygen of the individuals will be measured with a near-infrared spectrometer, and their energy consumption will be measured with a multisensory physical activity monitor. Additionally, both arterial stiffness, assessed with the arteriograph device, and respiratory muscle fatigue, evaluated using a mouth pressure measurement device, will be measured before and after the test.
In the second test, the maximal exercise capacity for the upper limb will again be evaluated by CPET and performed on the arm ergometer. The second test will be conducted 48 hours after the lower extremity exercise test. During the test in the second group, as in the first test, muscle oxygen will be measured with a near-infrared spectrometer, and energy expenditure with a multisensory physical activity monitor. Furthermore, arterial stiffness, determined by the arteriograph device, and respiratory muscle fatigue, assessed through a mouth pressure measurement system, will both be evaluated pre- and post-test.
Maximal Exercise Capacity
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 [carotid-femoral pulse wave velocity (PWV)]
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 [augmentation index (AIx)]
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 Oxygenation
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
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
Peripheral Muscle Strength
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
Respiratory Muscle Strength
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
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 (Forced vital capacity (FVC))
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 (Forced expiratory volume in first second (FEV1))
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 (FEV1/FVC)
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 (Flow rate 25-75% of forced expiratory volume (FEF25-75%))
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 (Peak flow rate (PEF))
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 Level
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
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
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
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.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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