Clinical Trial: Positional relationship between the onset of the stroke volume plateau and indices for exercise intensity prescription during incremental exercise testing (Japan)

Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063276) titled 'Positional relationship between the onset of the stroke volume plateau and indices for exercise intensity prescription during incremental exercise testing' on Oct. 14.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - Cardiovascular diseases for which aerobic exercise is prescribed in cardiac rehabilitation (particularly heart failure with preserved ejection fraction, HFpEF) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify, by within-participant comparison, where the point at which stroke volume (SV) reaches a plateau (SV plateau onset) lies relative to clinically used indices for exercise intensity prescription (anaerobic threshold [AT], the point of reaching the target heart rate by the Karvonen method, and the point of reaching 15 on the original Borg scale) during a single symptom-limited incremental exercise test in healthy young men. Hypothesis: The work rate at SV plateau onset does not coincide with that at AT, and the points of reaching the Karvonen target heart rate and Borg scale 15 are located at higher work rates than SV plateau onset. Basic objectives2 - Others

Intervention: Interventions/Control_1 - A single symptom-limited incremental exercise test on an electromagnetically braked cycle ergometer (Corival V2, Lode). Protocol: after 5 min of seated rest, a 3-min warm-up (0-10 W, 50-60 rpm) is followed by a ramp increment of 20 W/min (adjusted to 15 or 25 W/min according to exercise habits and body size) up to symptom-limited maximum (participant's request to stop or inability to maintain 50 rpm for 10 s or longer), then 3 min of unloaded pedaling and at least 15 min of recovery observation. Measurements: breath-by-breath expired gas analysis (AE-310S, Minato Medical Science), continuous SV by thoracic impedance cardiography (PhysioFlow Q-Link), continuous ECG monitoring (STS-2100, Nihon Kohden), blood pressure every 2 min (Tango M2, SunTech Medical), and original Borg scale for leg fatigue and dyspnea every minute. Body composition (InBody770), resting blood pressure, and a 12-lead ECG are obtained beforehand for screening. Duration/frequency: once, on one measurement day (about 120 min). The explanation session (about 30 min) is held on a separate day.

Eligibility: Age-lower limit - 18 years-old

Gender - Male Key inclusion criteria - (1) Healthy male students enrolled at the Narita Campus of the International University of Health and Welfare (2) Aged 18 years or older and younger than 25 years at the time of consent (3) Able to provide written informed consent of their own free will Key exclusion criteria - (1) History of, or current treatment for, heart disease, respiratory disease, hypertension, diabetes, or other chronic diseases (2) Resting blood pressure of 140/90 mmHg or higher, or resting 12-lead ECG findings judged inappropriate for exercise testing (3) Current smokers or those who smoked within the past year (4) Lower-limb injury or orthopedic disorder within the past 6 months that makes cycle ergometer exercise difficult (5) Regular use of medications affecting hemodynamics (6) Currently competing in endurance sports at the national level or higher (7) Students in the graduation research seminar supervised by the principal investigator (8) On the measurement day, failure to follow the pre-test conditions (no alcohol or strenuous exercise for 24 h, no caffeine or meals for 3 h before testing) or complaints of feeling unwell (re-scheduling the measurement is allowed) Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 10 Day Date of IRB - 2026 Year 10 Month 10 Day Anticipated trial start date - 2026 Year 10 Month 10 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072430

Disclaimer: Curated by HT Syndication.