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

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

Kazuya Yoshizawa

St. marianna university school of medicine yokohama city seibu hospital

1197-1 Yasashi-cho, Asahi-ku, Yokohama-shi, Kanagawa 241-0811 JAPAN

y-kazuya@marianna-u.ac.jp

Shinji Nemoto

St. marianna university school of medicine

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511 Japan

+81-45-985-6586

shinji4df@marianna-u.ac.jp

Recruiting

Dec. 04, 2023

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

other

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.

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.

Male

Heart failure

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.

D006333

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

Difficulties in activities of daily living
lower limb muscle mass

+81-44-977-8111

Nov. 10, 2023

No

none