UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057198 |
|---|---|
| Receipt number | R000065280 |
| Scientific Title | A survey on changes in physical function among older adults working irregular shifts |
| Date of disclosure of the study information | 2025/03/04 |
| Last modified on | 2026/03/05 09:07:40 |
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Basic information
Public title
A survey on changes in physical function among older adults working irregular shifts
Acronym
A survey on changes in physical function among older adults working irregular shifts
Scientific Title
A survey on changes in physical function among older adults working irregular shifts
Scientific Title:Acronym
Survey on physical function of working older adults
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify changes in the physical function of community-dwelling older adults engaged in irregular shift work. To achieve this, we will use data obtained from health check-ups of members of the Silver Human Resources Center.
Basic objectives2
Others
Basic objectives -Others
Additionally, a longitudinal study will be conducted to examine changes in their physical function and related factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical functional assessment; Skeltal-muscle mass index by body composition measurement, Blood pressure, pulse wave velocity, echocardiogram, cognitive function test (MoCA-J), muscle strength (grip strength, knee extension strength, tongue pressure, respiratory muscle strength), five times sit-to-stand test, sway of the center of the gravity, and walking speed.
Questionnaire survey: Basic attributes, job content, age, social interaction, sense of loneliness, depression, occupational dysfunction, and outlook on life.
Physical activity: After the physical functional assessment, participants were asked to wear an activity monitor for 7 days.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Members of the Silver Human Resources Center aged 65 or older.
Key exclusion criteria
Individuals with pacemakers or those unable to undergo body composition measurements due to limb amputation or similar conditions.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Ochi |
Organization
Seijoh University
Division name
Department of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai-City, Aichi, Japan
TEL
052-601-6000
ochi@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ochi |
Organization
Seijoh University
Division name
Department of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai-City, Aichi, Japan
TEL
052-601-6000
Homepage URL
ochi@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
None
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
The Research Ethics Committee of Seijoh University
Address
2-172 Fukinodai, Tokai-City, Aichi, Japan
Tel
052-601-6000
kenkyu-rinri@seijoh-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
| 2025 | Year | 03 | Month | 04 | 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
48
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study.
All participants in the Silver Human Resources Center's health check-ups on March 11, 2025 and March 28, 2025 who meet the selection criteria will be included.
Participants will be recruited by Silver Human Resources Center staff.
A flyer informing them about the health check-up will be created and distributed to all center members.
Another health check-up will be scheduled six months and one year later.
Management information
Registered date
| 2025 | Year | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065280
