UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049314 |
|---|---|
| Receipt number | R000056111 |
| Scientific Title | Effects of resting on a reclining chair: a randomized controlled crossover study |
| Date of disclosure of the study information | 2022/10/25 |
| Last modified on | 2023/10/26 19:30:56 |
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Basic information
Public title
Effects of resting on a reclining chair: a randomized controlled crossover study
Acronym
Effects of resting on a reclining chair: a controlled study
Scientific Title
Effects of resting on a reclining chair: a randomized controlled crossover study
Scientific Title:Acronym
Effects of resting on a reclining chair: a controlled study
Region
| Japan |
Condition
Condition
Male workers aged 20-64 with brain fatigue
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the improvement in work efficiency and sleepiness by resting on a reclining chair compared to a not-reclining chair
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Work efficiency test
Key secondary outcomes
Sleepiness scale, autonomic index, blood pressure, etc.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rest on a reclining chair
Interventions/Control_2
Rest on a not-reclining chair
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
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Male workers aged 20-64 years at the time of informed consent.
(2) Individuals who can provide written voluntary consent to participate in this study.
(3) Individuals with suspected brain fatigue.
Key exclusion criteria
Individuals with BMI less than 18.0 kg/m2 or greater than 35.0 kg/m2.
Some other exclusion criteria are applied.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Fujino |
Organization
Medical Corporation BOOCS
BOOCS Clinic Fukuoka
Division name
Clinic director
Zip code
8120025
Address
Random square building 6F, 6-18 Tenya-machi, Hakata-ku, Fukuoka City
TEL
092-283-6852
fujino-m@boocsclinic.com
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Kifuji |
Organization
Medical Corporation BOOCS, BOOCS Clinic Fukuoka
Division name
Chief nurse
Zip code
8120025
Address
Random square building 6F, 6-18 Tenya-machi, Hakata-ku, Fukuoka City
TEL
0922607871
Homepage URL
kifuji@boocsclinic.com
Sponsor or person
Institute
Medical Corporation BOOCS
Institute
Department
Personal name
Funding Source
Organization
Toyota Motor Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of BOOCS Clinic Fukuoka
Address
Random square building 6F, 6-18 Tenya-machi, Hakata-ku, Fukuoka City
Tel
092-283-6854
wakana@boocsclinic.com
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
医療法人社団ブックス BOOCSクリニック福岡（福岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 25 | 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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056111
