UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061388 |
|---|---|
| Receipt number | R000070239 |
| Scientific Title | Cognitive function, stress hormones, and physical and psychological states during working hours |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/27 15:06:22 |
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Basic information
Public title
Optimization of rest strategies according to time of day during working hours
Acronym
Optimizing rest strategies by time of day at work
Scientific Title
Cognitive function, stress hormones, and physical and psychological states during working hours
Scientific Title:Acronym
Cognitive function and psychophysiological states during working hours
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the factors associated with workplace presenteeism and appropriate rest strategies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SPQ (Single-Item Presenteeism Question)
Key secondary outcomes
Flicker Test
Stroop Test
Salivary cortisol
Psychological indices
Subjective fatigue
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Active rest: light-intensity exercise using a machine for 10 min.
Interventions/Control_2
Passive rest: resting in the supine position for 10 min..
Interventions/Control_3
Combined active and passive rest: alternating active rest and passive rest every 2 min
Interventions/Control_4
Control: usual rest for 10 min
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Japanese
2) Subjects agrees to participate in the experiment
Key exclusion criteria
Individuals with medical or psychiatric disorders, as well as those with visual impairment or paralysis.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Morimasa |
| Middle name | |
| Last name | Kato |
Organization
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Division name
Department of Health and Nutrition
Zip code
992-0025
Address
6-15-1 Tori-machi, Yonezawa, Yamagata, Japan
TEL
81-238-22-7375
m-kato@yone.ac.jp
Public contact
Name of contact person
| 1st name | Morimasa |
| Middle name | |
| Last name | Kato |
Organization
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Division name
Department of Health and Nutrition
Zip code
992-0025
Address
6-15-1 Tori-machi, Yonezawa, Yamagata, Japan
TEL
81-238-22-7375
Homepage URL
m-kato@yone.ac.jp
Sponsor or person
Institute
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Institute
Department
Personal name
Funding Source
Organization
Sailvan Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Address
6-15-1 Tori-machi, Yonezawa, Yamagata, Japan
Tel
81-238-22-7375
m-kato@yone.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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Not available at this time
Publication of results
Unpublished
Result
URL related to results and publications
Not available at this time
Number of participants that the trial has enrolled
20
Results
Presenteeism scores were positively correlated with subjective fatigue and negative mood states assessed by POMS, and negatively correlated with Stroop test accuracy, positive mood states, and comfort on the Two-Dimensional Mood Scale. Comfort increased significantly after active rest during breaks and after passive rest before the end of the workday.
Results date posted
| 2026 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 20 participants were included (7 men and 13 women; age range, 23-61 years).
Participant flow
Experiment 1 involved 20 participants and explored factors associated with presenteeism scores.
Experiment 2 examined four types of rest strategies and included 13 of the 20 participants who had participated in Experiment 1.
Adverse events
None
Outcome measures
Flicker Test
Stroop Test
Psychological indices
Subjective fatigue
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 01 | 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 | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070239
