UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051979 |
|---|---|
| Receipt number | R000059323 |
| Scientific Title | Physical burden study on cabin crew work movements |
| Date of disclosure of the study information | 2023/08/23 |
| Last modified on | 2024/07/24 13:17:10 |
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Basic information
Public title
Investigation of physical burden using objective indices in work movements of cabin crews
Acronym
Investigation of physical burden using objective indices in work movements of cabin crews
Scientific Title
Physical burden study on cabin crew work movements
Scientific Title:Acronym
Physical burden study on cabin crew work movements
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of proposed improvements in cabin crew work behaviors using objective indicators, focusing on work movements that are considered to be particularly physical burden in work of cabin crews.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity and sense of burden in trapezius/lumbar muscles during simulated work
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Improvement of work environment and use of mobility/transfer aids
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Employment Status: Full-time employee
Cabin crew experience: More than 1 year
BMI: Less than 25
Subjective symptoms: No pain in the shoulders, upper limbs, or lower back that interferes with work duties.
Consent to participate in this study has been obtained from the individual by signing a consent form.
Key exclusion criteria
Persons who do not meet at least one of the selection criteria
Those who have skin allergies to rubbing alcohol (50% ethanol).
Subjects with a history of tape rash
If the subject declines to participate in the research or withdraws his/her consent
In the event that the principal investigator and research assistants determine that the subject is inappropriate for the study, such as failure to follow the instructions of the research members or inability to follow instructions.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tomitagawa |
Organization
NIHON FUKUSHI UNIVERSITY
Division name
Faculty of Health Sciences Department of Rehabilitation Care Work course
Zip code
4750012
Address
26-2 Higashihaemi-cho, Handa-shi, Aichi-pref, JAPAN 475-0012
TEL
0569200111
tomitaga-s@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Tomitagawa |
Organization
NIHON FUKUSHI UNIVERSITY
Division name
Faculty of Health Sciences Department of Rehabilitation Care Work course
Zip code
4750012
Address
26-2 Higashihaemi-cho, Handa-shi, Aichi-pref, JAPAN 475-0012
TEL
0569200111
Homepage URL
tomitaga-s@n-fukushi.ac.jp
Sponsor or person
Institute
NIHON FUKUSHI UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
Japan Aerospace Exploration Agency
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
Ethical Review Committee for Research Involving Human Subjects, NIHON FUKUSHI UNIVERSITY
Address
26-2 Higashihaemi-cho, Handa-shi, Aichi-pref, JAPAN 475-0012
Tel
0569200111
rinri@ml.n-fukushi.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
| 2023 | Year | 08 | Month | 23 | 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
6
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
| 2023 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059323
