UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062887 |
|---|---|
| Receipt number | R000071999 |
| Scientific Title | Development of a Foot-Cooling Program to Reduce Heat Accumulation During Exercise in Individuals with Cervical Spinal Cord Injury |
| Date of disclosure of the study information | 2026/09/11 |
| Last modified on | 2026/09/11 17:36:23 |
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Basic information
Public title
Effects of Foot Cooling on Body Temperature During Exercise in Individuals with Cervical Spinal Cord Injury
Acronym
CSCI-FC Study
Scientific Title
Development of a Foot-Cooling Program to Reduce Heat Accumulation During Exercise in Individuals with Cervical Spinal Cord Injury
Scientific Title:Acronym
CSCI-FC Study
Region
| Japan |
Condition
Condition
Cervical spinal cord injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in core body temperature measured using a wearable core temperature sensor and tympanic temperature The wearable core temperature sensor is used from 15 minutes before exercise until 15 minutes after exercise Tympanic temperature is measured at 15 minutes before exercise immediately before exercise immediately after exercise and 15 minutes after exercise The time course and maximum increase in temperature are compared between the plantar cooling and non cooling conditions
Key secondary outcomes
Skin temperature body surface temperature heart rate and total distance traveled during 20 minutes of wheelchair exercise Changes in skin temperature body surface temperature and heart rate before during and after exercise are assessed Total distance traveled during 20 minutes of wheelchair exercise is measured and compared between the plantar cooling and non cooling conditions
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | 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 sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeyoshi |
| Middle name | |
| Last name | Shimoda |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu, Okawa, Fukuoka 831-8501, Japan
TEL
0944-89-2000
shimoda@ihwg.jp
Public contact
Name of contact person
| 1st name | Takeyoshi |
| Middle name | |
| Last name | Shimoda |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu, Okawa, Fukuoka 831-8501, Japan
TEL
0944-89-2000
Homepage URL
shimoda@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Kyushu District Ethics Review Committee
Address
137-1 Enokizu, Okawa, Fukuoka 831-8501, Japan
Tel
0944-89-2031
q-rinri@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
6
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071999
