Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062170) titled 'Exploratory Pilot Study of the Acute Effects of Hydrogen Inhalation on Post-Exercise Oxidative Stress, Vascular Responses, and Exercise Performance in Female Rowers' on July 8.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Healthy adult female rowers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to exploratorily evaluate the acute effects of approximately 4% hydrogen gas inhalation on post-exercise oxidative stress markers, antioxidative capacity, peripheral vascular responses, and exercise performance in healthy adult female rowers. This study is not intended to provide confirmatory evidence of efficacy, but rather to generate hypotheses and assess feasibility for future randomized crossover trials.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Placebo inhalation condition: Participants inhaled room air through the inhalation device for 30 minutes. They then completed one incremental exercise test using a Wattbike. Blood and urine sampling, ultrasound assessment of peripheral venous diameter, breath hydrogen measurement, and rating of perceived exertion using the Borg scale were performed at baseline, immediately post-exercise, and 60 minutes post-exercise. This condition was conducted on the same day and preceded the hydrogen inhalation condition.
Interventions/Control_2 - Hydrogen inhalation condition: After the placebo inhalation condition and a 60-minute recovery interval, participants inhaled air containing approximately 4% hydrogen gas for 30 minutes using a hydrogen inhalation device. They then completed one incremental exercise test using a Wattbike. Blood and urine sampling, ultrasound assessment of peripheral venous diameter, breath hydrogen measurement, and rating of perceived exertion using the Borg scale were performed at pre-inhalation baseline, immediately post-exercise, and 60 minutes post-exercise. The hydrogen concentration was set below the lower explosive limit, and safety was managed with adequate ventilation and gas detector monitoring during testing.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Female
Key inclusion criteria - Healthy adult females aged 18 to 30 years
Rowers with national-level competitive experience
Participants who received oral and written explanations of the study aims, procedures, and potential risks and provided written informed consent
Participants able to complete incremental exercise testing using a Wattbike after hydrogen and placebo inhalation conditions
Key exclusion criteria - Individuals with cardiovascular, respiratory, neuromuscular, orthopedic, or injury-related conditions that may interfere with safe completion of exercise testing
Individuals with poor physical condition, fever, acute illness, or marked fatigue on the test day
Individuals who are pregnant or may be pregnant
Individuals judged by the principal investigator to be unsuitable for hydrogen inhalation or study procedures for safety reasons
Individuals otherwise judged by the principal investigator to be inappropriate for participation in the study
Target Size - 4
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2023 Year 03 Month 27 Day
Date of IRB - 2023 Year 03 Month 01 Day
Anticipated trial start date - 2023 Year 12 Month 08 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=R000071146
Disclaimer: Curated by HT Syndication.
