Association between exercise skeletal muscle oxygen consumption and sarcopenia complications in patients with chronic heart failure

JRCT ID: jRCT1030230738

Registered date:27/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Heart failure
• Date of first enrollment: 27/03/2024
• Target sample size: 108
• Study type: Interventional

Intervention(s)

Measurement of Muscle oxygen saturation during cardiopulmonary exercise testing.
Measurement of skeletal muscle mass.
To survey the patients with difficulty in activities of daily living.

Outcome(s)

Primary Outcome

Lower extremity muscle oxygen utilization capacity (lower extremity muscle oxygen saturation, arterial-mixed venous oxygen difference) during cardiopulmonary exercise testing.
Lower Limb Muscle Strength

Secondary Outcome

Difficulties in activities of daily living
lower limb muscle mass

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Male
• Include criteria: Male heart failure patients aged 40 years or older with a diagnosis of heart failure and scheduled to undergo cardiopulmonary exercise testing as an outpatient at Kawasaki City Tama Hospital will be included. 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 Treatment of Acute and Chronic Heart Failure (2017 revised edition). The severity of heart failure will be defined as stage C (symptomatic heart failure) according to the AHA/ACC (American Heart Association / American College of Cardiology) stage classification.

Exclude criteria

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, uncontrolled symptomatic heart failure, acute pulmonary embolism or infarction, acute myocarditis or pericarditis, dissecting aortic aneurysm or suspected aortic aneurysm, acute infection with fever, body pain, or lymph gland swelling, or any physical impairment that would interfere with safety or adequate performance of the test.
Patients with orthopedic or central nervous system diseases that make it difficult to perform the exercise stress test.
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 surgery in the past and have some metal in their body.
Patients who have a pacemaker.
Persons who could not give consent to participate in this study.
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Related Information

• Primary Sponsor: Taiki Yamasaki