UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054089 |
|---|---|
| Receipt number | R000061762 |
| Scientific Title | Investigation of the beneficial effects of high-intensity interval exercise with warm-water foot baths on efficient immune activation. |
| Date of disclosure of the study information | 2024/04/08 |
| Last modified on | 2024/04/08 12:18:51 |
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Basic information
Public title
Investigation of the beneficial effects of high-intensity interval exercise with warm-water foot baths on efficient immune activation.
Acronym
Investigation of the beneficial effects of high-intensity interval exercise with warm-water foot baths on efficient immune activation.
Scientific Title
Investigation of the beneficial effects of high-intensity interval exercise with warm-water foot baths on efficient immune activation.
Scientific Title:Acronym
Investigation of the beneficial effects of high-intensity interval exercise with warm-water foot baths on efficient immune activation.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to investigate whether high-intensity interval exercise with warm water foot baths would effectively activate the immune system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary secreted immunoglobulin A (sIgA)
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
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
High-intensity interval upper limb ergometer exercise with foot bath.
Interventions/Control_2
Moderate intensity upper limb ergometer exercise with foot bath.
Interventions/Control_3
Sitting at rest with foot bath
Interventions/Control_4
High-intensity interval upper limb ergometer exercise without foot bath.
Interventions/Control_5
Moderate intensity upper limb ergometer exercise without foot bath.
Interventions/Control_6
Sitting at rest without foot bath
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
Key inclusion criteria
Students who have an electrocardiogram with no abnormalities in their physical examination (according to the subject's self-report) and who agree with the purpose of the study.
Key exclusion criteria
Persons who fulfil any of the following
(1) Persons who have been indicated to have a cardiovascular disease in a medical examination.
(2) Persons who have a locomotor disease in the upper limb and have difficulty performing the hand ergometer exercise conducted in this study.
(3) Smokers.
4) Persons who show allergic reactions to zinc (synthetic acrylic fibres) and alcohol.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
6540142
Address
7-10-2, Suma, Kobe, Hyogo, JAPAN
TEL
078-792-2555
onoku@tiger.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
6540142
Address
7-10-2, Tomogaoka, Suma, Kobe, Hyogo, JAPAN
TEL
078-792-2555
Homepage URL
onoku@tiger.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Kumiko ONO
Funding Source
Organization
NORITZ Nukumori Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences, Health Sciences Ethical Review Board
Address
7-10-2, Suma-ku, Kobe, Hyogo, JAPAN
Tel
078-792-2555
syomu2@ams.kobe-u.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
| 2024 | Year | 04 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 10 | 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 | 04 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061762
| Research Plan | |
|---|---|
| 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 |
