Relation of leg muscle oxygen availability to leg muscle volume and leg muscle fitness during incremental exercise in patients with heart failure.

JRCT ID: jRCT1030230487

Registered date:04/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure
• Date of first enrollment: 19/06/2024
• Target sample size: 125
• Study type: Interventional

Intervention(s)

Measurement of cardiac output, cardiac output, cardiac index, and muscle oxygen saturation during cardiopulmonary exercise testing.
To measure muscle oxygen saturation during the measurement of lower limb muscle strength and lower limb muscle endurance.
To survey the patients' difficulty in performing 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
Lower limb muscle endurance

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 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.

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, 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.

Related Information

• Primary Sponsor: Kazuya Yoshizawa