UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055112 |
|---|---|
| Receipt number | R000062933 |
| Scientific Title | Effects of water walking on mood states and autonomic nervous system activity in university students: compared with land walking |
| Date of disclosure of the study information | 2024/07/31 |
| Last modified on | 2025/07/31 16:36:36 |
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Basic information
Public title
Effects of water walking on mood states and autonomic nervous system activity in university students: compared with land walking
Acronym
Effects of water walking on mood states and autonomic nervous system activity in university students: compared with land walking
Scientific Title
Effects of water walking on mood states and autonomic nervous system activity in university students: compared with land walking
Scientific Title:Acronym
Effects of water walking on mood states and autonomic nervous system activity in university students: compared with land walking
Region
| Japan |
Condition
Condition
Anxiety, Depression
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of water walking on mood states and autonomic nervous system activity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-Dimensional Mood Scale at rest, immidiately after water walking, and 20 minutes after water walking
Key secondary outcomes
RPE during water walking
PNS Index and SNS Index at rest, during water walking, immidiately after water walking, and 20 minutes after water walking
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
30 minutes water walking
Interventions/Control_2
30 minutes land walking
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
| 20 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students enrolled at Tokyo University of Marine Science and Technology
Those who have given written consent to participate in the study
Those who sign up for Personal Accident Insurance for Students Pursuing Education and Research
Those who undergo regular health checkups and have no particular symptoms that would interfere with their participation in the experiment
Those who are not experiencing any symptoms such as fever
Those who has enough sleep the day before measurement
Those who have had at least 2 hours since eating(As far as possible, limit your intake of caffeine such as tea and coffee)
Those who have not consumed a large amount of alcohol the previous day and are not under the influence of alcohol
Those who can carry out study and manage their own physical condition in the schedule presented by researcher
Key exclusion criteria
Those who do not meet the key selection criteria
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | FUJIMOTO |
Organization
Tokyo University of Marine Science and Technology
Division name
School of Marine Life Science, Department of Ocean Policy and Culture
Zip code
108-8477
Address
4-5-7 Konan, Minato, Tokyo
TEL
03-5463-0638
kfujim1@kaiyodai.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | FUJIMOTO |
Organization
Tokyo University of Marine Science and Technology
Division name
School of Marine Life Science, Department of Ocean Policy and Culture
Zip code
108-8477
Address
4-5-7 Konan, Minato, Tokyo
TEL
03-5463-0638
Homepage URL
kfujim1@kaiyodai.ac.jp
Sponsor or person
Institute
Tokyo University of Marine Science and Technology
Institute
Department
Personal name
FUJIMOTO Koichi
Funding Source
Organization
Tokyo University of Marine Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Subjects Research Ethics Review Committee of Tokyo University of Marine Science and Technology
Address
4-5-7 Konan, Minato, Tokyo
Tel
03-5463-4197
ke-ken@o.kaiyodai.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
東京海洋大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 31 | 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
10
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
| 2024 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062933
