Tokyo, Sept. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062887) titled 'Effects of Foot Cooling on Body Temperature During Exercise in Individuals with Cervical Spinal Cord Injury' on Sept. 11.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - Cervical spinal cord injury Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate whether plantar cooling during wheelchair exercise in a hot environment suppresses the increase in core body temperature in wheelchair athletes with cervical spinal cord injury. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The plantar cooling condition is performed first followed by the non cooling condition In the plantar cooling condition temperature controlled cooling packs at approximately 12 C are applied to both plantar surfaces from 15 minutes before exercise throughout 20 minutes of wheelchair exercise and until 15 minutes after exercise After the first condition participants rest for at least 60 minutes in a cooling room The non cooling condition is started after tympanic temperature has returned to the pre exercise level In the non cooling condition no plantar cooling is applied while all other measurement and exercise procedures are identical Interventions/Control_2 - The non cooling condition is performed first followed by the plantar cooling condition In the non cooling condition participants perform 20 minutes of wheelchair exercise without plantar cooling After the first condition participants rest for at least 60 minutes in a cooling room The plantar cooling condition is started after tympanic temperature has returned to the pre exercise level In the plantar cooling condition temperature controlled cooling packs at approximately 12 C are applied to both plantar surfaces from 15 minutes before exercise throughout 20 minutes of wheelchair exercise and until 15 minutes after exercise

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - 1 Male wheelchair athletes with cervical spinal cord injury who regularly participate in wheelchair sports 2 Participants aged 18 to 60 years at the time of informed consent 3 Participants who understand the study procedures and voluntarily provide written informed consent 4 Participants with sufficient cognitive and decision making capacity Key exclusion criteria - 1 Participants with a history of cardiovascular respiratory or metabolic disease for whom exercise in a hot environment is considered medically inappropriate 2 Participants with health problems such as fever fatigue or symptoms of heat illness on the day of measurement 3 Participants with skin disease injury pressure ulcers or other conditions of the feet that make application of the cooling packs difficult or inappropriate 4 Participants with a history of allergic or hypersensitivity reactions to the cooling packs or measurement devices 5 Participants who are unable to tolerate or appropriately use the core temperature measurement devices 6 Participants who are unable to adequately understand the study procedures or provide informed consent Target Size - 30

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 05 Month 26 Day Date of IRB - 2025 Year 05 Month 27 Day Anticipated trial start date - 2025 Year 09 Month 06 Day Last follow-up date - 2025 Year 09 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071999

Disclaimer: Curated by HT Syndication.