Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059418) titled 'The Effects of hot water immersion for preventing heatstroke' on Oct. 16.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Bathclin corporation
Condition:
Condition - Not selected
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to compare the effects of two different bathing methods and examine the differences in thermoregulation in a hot environment
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Bathing for 10 minutes at 41 celsius for 2 weeks
Interventions/Control_2 - Shower bath for washing only
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - Healthy men aged 18 to 69
Those who usually shower or bathe in a bathtub less than twice a week
Those with a bathtub suitable for full-body bathing at home
Those who can cycle an exercise bike for 30 minutes at hot environment
Those who can provide written consent after receiving an explanation of the study details prior to the study
Those who can shower or bathe in a bathtub for two consecutive weeks at the start of the study
Those who can insert a rectal temperature probe themselves
Key exclusion criteria - Those who exercise regularly
Those with skin problems
Those with extremely irregular lifestyle habits, including eating and sleeping habits
Those who are participating in other clinical trials or monitors at the start of this study, or who plan to participate in other clinical trials or monitors during the planned period of this study
Those using a pacemaker, Holter monitor, or cardiopulmonary bypass
Those with a history of cardiovascular disease (myocardial infarction, angina pectoris, heart failure, arrhythmia, arteriosclerosis, stroke, varicose veins, hypertension), rectal disease (inflammatory bowel disease, post-rectal surgery, etc.), perianal inflammation and bleeding, hemorrhoids, or kidney disease (chronic glomerulonephritis, diabetic nephropathy, renal failure, nephrotic syndrome)
Those who have fallen asleep while bathing, or who have experienced dizziness or fainting during or after bathing
Those deemed ineligible by the study director or investigators
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 19 Day
Date of IRB - 2025 Year 08 Month 28 Day
Anticipated trial start date - 2025 Year 10 Month 23 Day
Last follow-up date - 2026 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067947
Disclaimer: Curated by HT Syndication.