UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059481 |
|---|---|
| Receipt number | R000068031 |
| Scientific Title | Effects of Pseudo-Abdominal Wearing on Energy Expenditure and Muscle Activity |
| Date of disclosure of the study information | 2025/10/21 |
| Last modified on | 2025/10/20 23:41:42 |
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Basic information
Public title
Effects of Pseudo-Abdominal Wearing on Energy Expenditure and Muscle Activity
Acronym
Effects of Pseudo-Abdominal Wearing on Energy Expenditure and Muscle Activity
Scientific Title
Effects of Pseudo-Abdominal Wearing on Energy Expenditure and Muscle Activity
Scientific Title:Acronym
Effects of Pseudo-Abdominal Wearing on Energy Expenditure and Muscle Activity
Region
| Japan |
Condition
Condition
Premature birth, abnormal delivery
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effects of abdominal weight associated with fetal growth on posture, muscle activity, and energy consumption.
Basic objectives2
Others
Basic objectives -Others
burden feeling
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle activity, postural changes, respiratory ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Pseudo-abdominal attachment
Interventions/Control_2
Pseudo-abdominal and MSG attachment
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Individuals capable of wearing an approximately 8 kg simulated abdomen
Key exclusion criteria
Individuals who are allergic to medical tape
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Okishima |
Organization
Shinshu University
Division name
Faculty of Education
Zip code
380-8544
Address
6-Ro, Nishinagano, Nagano-city, Nagano
TEL
0262384186
okishima_naoko@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Okishima |
Organization
Shinshu University
Division name
Faculty of Education
Zip code
380-8544
Address
6-Ro, Nishinagano, Nagano-city, Nagano
TEL
0262384186
Homepage URL
okishima_naoko@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Naoko Okishima
Funding Source
Organization
Shinshu University
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
Research Promotion Department, Research Support Section
Address
3-1-1 Asahi, Matsumoto-city, Nagano
Tel
0263-37-2029
ayabe_masato@gm.shinshu-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 | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2034 | 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
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068031
