UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053906 |
|---|---|
| Receipt number | R000061538 |
| Scientific Title | Effect of increased venous blood flow with lower limb passive heating for 8 weeks on calf venous volume and compliance |
| Date of disclosure of the study information | 2024/03/19 |
| Last modified on | 2024/03/19 18:19:26 |
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Basic information
Public title
Effect of increased venous blood flow on venous vascular properties
Acronym
Effect of increased venous blood flow on venous vascular properties
Scientific Title
Effect of increased venous blood flow with lower limb passive heating for 8 weeks on calf venous volume and compliance
Scientific Title:Acronym
Effect of increased venous blood flow with lower limb passive heating for 8 weeks on calf venous volume and compliance
Region
| Japan |
Condition
Condition
healthy man and woman
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of increased venous blood flow for 8 weeks on venous volume and venous compliance
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the effect of increased venous blood flow for 8 weeks on venous volume and venous compliance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volume and compliance in calf veins
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
condition of increased venous blood flow
Interventions/Control_2
condition of suppressed increase in venous blood flow
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy man and woman
Key exclusion criteria
None of the participants had been diagnosed as having cardiovascular disease and epilepsy.
Individuals who are not in good health on the day of the experiment.
Individuals who have been advised by a physician to refrain from exercise.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Iimura |
Organization
Toyo university
Division name
Department of Nutritional Sciences, Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11, Akabanedai, Kita-ku, Tokyo
TEL
03-5924-2818
iimura581@toyo.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Iimura |
Organization
Toyo university
Division name
Department of Nutritional Sciences, Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11, Akabanedai, Kita-ku, Tokyo
TEL
03-5924-2818
Homepage URL
iimura581@toyo.jp
Sponsor or person
Institute
Toyo university
Institute
Department
Personal name
Funding Source
Organization
Toyo university
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
Toyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2100, Kujirai, Kawagoe city, Saitama, Japan
Tel
049-239-1440
mlkks@toyo.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
| 2024 | Year | 03 | Month | 19 | 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
20
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
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061538
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
