UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063164 |
|---|---|
| Receipt number | R000072295 |
| Scientific Title | Effects of different compression levels of elastic stockings on calf muscle pump function in healthy male university students |
| Date of disclosure of the study information | 2026/10/03 |
| Last modified on | 2026/10/03 17:58:18 |
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Basic information
Public title
Effects of different compression levels of elastic stockings on calf muscle pump function in healthy male university students
Acronym
Effects of different compression levels of elastic stockings on calf muscle pump function in healthy male university students
Scientific Title
Effects of different compression levels of elastic stockings on calf muscle pump function in healthy male university students
Scientific Title:Acronym
Effects of different compression levels of elastic stockings on calf muscle pump function in healthy male university students
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of elastic stocking compression level (none, low, high) on calf muscle pump function and subjective comfort in healthy male university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ejection fraction (EF) measured by air plethysmography (APG) under each condition
Key secondary outcomes
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
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
No-compression condition: a thin jersey garment of similar thickness is worn on the lower leg, and APG measurement (approx. 60 min) is performed once.
Interventions/Control_2
Low-compression condition: medical elastic stocking (18-21 mmHg, Sigvaris Class I) is worn, and APG measurement is performed once.
Interventions/Control_3
High-compression condition: medical elastic stocking (34-46 mmHg, Sigvaris Class III) is worn, and APG measurement is performed once.
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Students enrolled at the Narita Campus of International University of Health and Welfare
(2) Individuals who provide written informed consent
Key exclusion criteria
(1) History of lower-limb vascular disease (e.g., deep vein thrombosis, varicose veins)
(2) History of lower-limb surgery or orthopedic disease
(3) Neuromuscular disease
(4) Apparent lower-limb edema
(5) BMI of 30 or higher
(6) Students in the graduation research seminar supervised by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
TEL
0476-20-7746
shinta.t@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
TEL
0476-20-7746
Homepage URL
shinta.t@iuhw.ac.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
Ethics Committee of International University of Health and Welfare (Chiba area)
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
Tel
0476-20-7708
rinri_md@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 | 10 | 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 | 09 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072295
