jRCT1030230487招募中不适用
Relation of leg muscle oxygen availability to leg muscle volume and leg muscle fitness during incremental exercise in patients with heart failure.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 主要终点
- Lower extremity muscle oxygen utilization capacity
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 40age old over 至 No limit（—）
- 性别
- Male
入选标准
- •Male heart failure patients aged 40 years or older who have been diagnosed with heart failure and are scheduled to undergo cardiopulmonary exercise testing in an outpatient setting will be included in the study. Diagnostic criteria for heart failure will be in accordance with the diagnostic criteria for patients with chronic heart failure in the Guidelines for the Diagnosis and Management of Acute and Chronic Heart Failure (2017 revised edition). The severity of heart failure will be defined as stage C of the AHA/ACC (American Heart Association / American College of Cardiology) stage classification, i.e., symptomatic heart failure.
排除标准
- •The following are contraindications to the exercise stress test as outlined by the American College of Sports Medicine. These are: critical myocardial ischemia or acute myocardial infarction (within 2 days of onset), recent nonsignificant resting ECG changes suggestive of other acute cardiac events, unstable angina, symptomatic or poorly controlled arrhythmia resulting in hemodynamic abnormalities, symptomatic severe aortic stenosis, poorly controlled symptomatic heart failure, acute pulmonary embolism or pulmonary infarction, acute myocarditis or pericarditis, dissecting aortic aneurysm or suspected aortic aneurysm, acute pulmonary embolism, or pulmonary infarction. Symptomatic severe aortic valve stenosis, symptomatic uncontrolled heart failure, acute pulmonary embolism or pulmonary infarction, acute myocarditis or pericarditis, dissecting aortic aneurysm or its suspicion, acute infection with fever, body pain and lymph gland swelling.
- •Patients with orthopedic or central nervous system diseases that make it difficult to perform exercise stress tests or muscle fitness measurements.
- •Patients with cognitive impairment that makes it difficult to perform exercise stress tests or skeletal muscle measurements.
- •Overweight (>100 kg) that exceeds the maximum permissible weight of the measuring device.
- •Those who have difficulty in applying ECG stickers with sufficient fixation due to hypersensitivity of the skin.
- •Those who have difficulty in assessing subjective difficulty during exercise due to severe vision loss or blindness.
- •Patients who have undergone hemodialysis
- •Those who have undergone surgical operation within 6 months.
- •Those who have undergone surgical procedures in the past and have any metal in their body.
- •Persons who could not give consent to participate in this study.
结局指标
主要结局
Lower extremity muscle oxygen utilization capacity
lower extremity muscle oxygen saturation, arterial-mixed venous oxygen difference during cardiopulmonary exercise testing
次要结局
未报告次要终点
研究者
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