UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053403 |
|---|---|
| Receipt number | R000060947 |
| Scientific Title | Association of Risk of Locomotive Syndrome with Objective Sleep Measures in Young Women. |
| Date of disclosure of the study information | 2024/01/21 |
| Last modified on | 2024/01/21 12:31:19 |
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Basic information
Public title
Association of Risk of Locomotive Syndrome with Objective Sleep Measures in Young Women.
Acronym
Association of Locomotive Syndrome with Sleep in Young Women.
Scientific Title
Association of Risk of Locomotive Syndrome with Objective Sleep Measures in Young Women.
Scientific Title:Acronym
Association of Locomotive Syndrome with Sleep in Young Women.
Region
| Japan |
Condition
Condition
Young women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The first objective of this study was to determine whether sleep-promoting behaviors aimed at improving sleep habits and viewing sleep education videos reduce the risk of locomotive syndrome in young women. The second objective is to determine which objective sleep measures are associated with risk of locomotive syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Locomotive syndrome risk test (the two-step test, the stand-up test, and the 25-question geriatric locomotive function scale [GLFS-25])
Key secondary outcomes
Objective sleep measures (e.g., bedtime, wake-up time, total sleep)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementing sleep-promoting behaviors
Viewing sleep education movies
Interventions/Control_2
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
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
1. 18 to 24 years old
2. women
3. people who can provide written consent for participation in this study
Key exclusion criteria
1. people who are prohibited from exercise by their doctors
2. people with insomnia or other sleep disorders and are currently undergoing treatment
3. people with depression or other mental illnesses and are currently undergoing treatment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Tanaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
7315132
Address
1-7-1, Kagamiyama, Higashi-hiroshima
TEL
0824246585
ryotana@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tanaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1, Kagamiyama, Higashi-hiroshima
TEL
0824246585
Homepage URL
ryotana@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Hiroshima University, Graduate School of Humanities and Social Sciences
Address
1-7-1, Kagamiyama, Higashi-hiroshima
Tel
082-424-6725
ed-ken-zai@office.hiroshima-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 | 01 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | 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 | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060947
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
