UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062016 |
|---|---|
| Receipt number | R000070604 |
| Scientific Title | Effects of Sedentary Time Reduction on Late-Onset Hypogonadism: An Interventional Study |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/23 06:02:04 |
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Basic information
Public title
Effects of Sedentary Time Reduction on Late-Onset Hypogonadism: An Interventional Study
Acronym
A Study Examining the Effects of Reducing Prolonged Sitting on Male Menopause Symptoms
Scientific Title
Effects of Sedentary Time Reduction on Late-Onset Hypogonadism: An Interventional Study
Scientific Title:Acronym
SLIM-LOH
Region
| Japan |
Condition
Condition
Late-Onset Hypogonadism
Classification by specialty
| Urology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of health guidance aimed at reducing sedentary time among working men wearing wearable activity trackers, and to determine whether such guidance improves LOH syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Testosteron
Key secondary outcomes
Aging Males' Symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom |
Interventions/Control_1
Physical activity
Interventions/Control_2
No intervention
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy adult men aged 40 to 65 2.Men who have given their consent to participate in the study 3.Men who can read and write Japanese
Key exclusion criteria
1.Men with no history of injury or surgery on the wrist where the activity tracker will be worn 2.Men with no hair on the back of the head
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Niigata University of Health and Welfare
Division name
Department of Nursing
Zip code
9503198
Address
1398 Shimami-cho,Kita-Ku,Niigata City,Niigata
TEL
0252574545
noriko-yamaguchi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Niigata University of Health and Welfare
Division name
Department of Nursing
Zip code
9503198
Address
1398 Shimami-cho,Kita-Ku,Niigata City,Niigata
TEL
0252574545
Homepage URL
noriko-yamaguchi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho,Kita-Ku,Niigata City,Niigata
Tel
0252574545
noriko-yamaguchi@nuhw.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 | 06 | Month | 30 | 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
| 2026 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2028 | 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 | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070604
