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临床试验/NCT07148518
NCT07148518已完成不适用

Comparison of Upper and Lower Limb Maximal Exercise Capacities, Arterial Stiffness, Muscle Oxygenation and Energy Consumption During Tests in Patients With Coronary Artery Disease

Gazi University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Maximal Exercise Capacity

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18-85 with coronary artery disease diagnosed by conventional or CT angiography
  • •Clinically stable
  • •Willing to participate

排除标准

  • •Heart failure diagnosis
  • •Moderate/severe valvular heart disease
  • •Orthopedic, neurological, or pulmonary conditions limiting exercise testing/capacity
  • •Contraindications per ACSM guidelines
  • •Prior coronary artery bypass graft surgery

研究组 & 干预措施

Lower Extremity Group

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.

Upper Extremity Group

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.

结局指标

主要结局

Maximal Exercise Capacity

时间窗: 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.

Arterial Stiffness [carotid-femoral pulse wave velocity (PWV)]

时间窗: 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.

Arterial Stiffness [augmentation index (AIx)]

时间窗: 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.

次要结局

  • Peripheral Muscle Oxygenation(Through study completion, an average of 1 year)
  • Energy Consumption(Through study completion, an average of 1 year)
  • Peripheral Muscle Strength(Through study completion, an average of 1 year)
  • Respiratory Muscle Strength(Through study completion, an average of 1 year)
  • Respiratory Muscle Fatigue(Through study completion, an average of 1 year)
  • Pulmonary Function (Forced vital capacity (FVC))(Through study completion, an average of 1 year)
  • Pulmonary Function (Forced expiratory volume in first second (FEV1))(Through study completion, an average of 1 year)
  • Pulmonary Function (FEV1/FVC)(Through study completion, an average of 1 year)
  • Pulmonary Function (Flow rate 25-75% of forced expiratory volume (FEF25-75%))(Through study completion, an average of 1 year)
  • Pulmonary Function (Peak flow rate (PEF))(Through study completion, an average of 1 year)
  • Physical Activity Level(Through study completion, an average of 1 year)
  • Chronotropic Response Assessment(Through study completion, an average of 1 year)
  • Dyspnea Perception(Through study completion, an average of 1 year)
  • Fatigue Perception(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meral Boşnak Güçlü

Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Gazi University

研究点 (1)

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