UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062458 |
|---|---|
| Receipt number | R000071455 |
| Scientific Title | Immediate effects of a single hot pack application to the buttocks and posterior thighs on physical function and motor performance in elderly wheelchair users in a long-term care health facility: a single-center, randomized crossover trial |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/03 19:48:57 |
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Basic information
Public title
Immediate effects of heat therapy on the buttocks and thighs in elderly wheelchair users in a long-term care health facility
Acronym
HOT-WHEEL Study (Heat On Thighs and buttocks for Wheelchair-using Elderly in Long-term care)
Scientific Title
Immediate effects of a single hot pack application to the buttocks and posterior thighs on physical function and motor performance in elderly wheelchair users in a long-term care health facility: a single-center, randomized crossover trial
Scientific Title:Acronym
HOT-WHEEL-RCT (Heat Therapy on Buttocks & Thighs for Wheelchair Elderly: a Randomized Crossover Trial)
Region
| Japan |
Condition
Condition
Frail elderly requiring long-term care (age-related motor function decline and disuse syndrome)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immediate effects of a 15-minute hot pack application to the buttocks and posterior thighs on physical function and motor performance in elderly nursing home residents who primarily use wheelchairs. This crossover trial aims to clarify the clinical utility of a passive heat intervention for improving rehabilitation efficiency and reducing fall risk.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Functional Reach Test (FRT) scores (in standing and sitting positions) immediately after the intervention
Key secondary outcomes
30-Second Chair Stand Test (STS-30) score
Range of Motion (ROM) for hip flexion and knee extension
Berg Balance Scale (BBS) score
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A 15-minute hot pack application to the buttocks and posterior thighs.
Interventions/Control_2
A 15-minute resting period in a comfortable position while seated in a wheelchair.
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
| 40 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Residents of a long-term care health facility.
2.Primary mode of daily mobility is a wheelchair.
3.Capable of standing up with partial assistance or supervision.
Key exclusion criteria
1.Capable of walking independently or with a walker.
2.Completely dependent for standing up (requiring full assistance) to avoid floor effects.
3.Severe dementia making it difficult to understand instructions and perform physical tests.
4.Contraindications for heat therapy on the buttocks and thighs, such as severe skin diseases, acute inflammation, or impaired thermal sensation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ijiri |
| Middle name | |
| Last name | Tomohito |
Organization
Medical Corporation Juzankai Kiba Hospital
Division name
Corporate Rehabilitation Department
Zip code
5780941
Address
4-2-8 Iwadacho, Higashi-Osaka City, Osaka Prefecture
TEL
0729616888
jicchi.08p021@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Jikko |
Organization
Van-Vert Long-Term Care Health Facility, Juyama Medical Corporation
Division name
Corporate Rehabilitation Department
Zip code
5780941
Address
4-2-8 Iwadacho, Higashi-Osaka City, Osaka Prefecture
TEL
0729616888
Homepage URL
jicchi.08p021@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Van-Vert Long-Term Care Health Facility, Juyama Medical Corporation
Address
4-2-8 Iwadacho, Higashi-Osaka City, Osaka Prefecture
Tel
0729616888
jicchi.08p021@gmail.com
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
介護老人保健施設ヴァンベール（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 03 | 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
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071455
