Tokyo, Dec. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060099) titled 'To investigate the effectiveness of cooling body temperature raised by exercise in a hot environment with cold water using a heatstroke relief bag' on Dec. 22.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - Osaka University of Health and Sport Sciences
Condition:
Condition - Healthy Volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study was to verify the effectiveness of a heatstroke relief bag, which is relatively easy to prepare and practical, and a 10-minute cold water immersion method using a small amount (5 or 80 L) of cold water (approximately 5 degree) or tap water (approximately 20 degree) on core body temperature that has risen due to exercise in a hot environment.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The subjects entered an environmentally controlled room set at a temperature of 40 degree and humidity of 60%, sat in a chair and rested for five minutes, then walked for three minutes on a treadmill set at a speed of 5 km/h and a 2% incline as a warm-up.
They then ran for 30 minutes on a treadmill set at a speed of 8-9 km/h and a 2% incline. After finishing the run, the subjects lay supine in a heatstroke aid bag and were immersed in water cooled to approximately 5 degree, which was poured over them at a constant rate, for a total of 10 minutes.
Interventions/Control_2 - The subjects entered an environmentally controlled room set at a temperature of 40 degree and humidity of 60%, sat in a chair and rested for five minutes, then walked for three minutes on a treadmill set at a speed of 5 km/h and a 2% incline as a warm-up.
They then ran for 30 minutes on a treadmill set at a speed of 8-9 km/h and a 2% incline. After finishing the run, the subjects lay supine in a heatstroke aid bag and were immersed in 80 liters of water cooled to approximately 20 degree, which was poured over them at a constant rate, for a total of 10 minutes.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - 1) Male individuals aged 18-29.
2) Persons who can fully understand the purpose and sign the consent form.
3) Persons who can comply with the intervention.
Key exclusion criteria - 1) Chronic health problems
2) A history of heatstroke this fiscal year
3) A history of cardiovascular, metabolic, or respiratory disease
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 25 Day
Anticipated trial start date - 2025 Year 12 Month 25 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068730
Disclaimer: Curated by HT Syndication.