UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048335 |
|---|---|
| Receipt number | R000055091 |
| Scientific Title | Building a comprehensive exercise program aimed at optimizing the physique for underweight young women. |
| Date of disclosure of the study information | 2022/07/11 |
| Last modified on | 2025/01/12 13:38:42 |
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Basic information
Public title
Building a comprehensive exercise program aimed at optimizing the physique for underweight young women.
Acronym
Building an exercise program for underweight young women
Scientific Title
Building a comprehensive exercise program aimed at optimizing the physique for underweight young women.
Scientific Title:Acronym
Building an exercise program for underweight young women.
Region
| Japan |
Condition
Condition
underweight
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to build a comprehensive exercise program that includes dietary guidance and psychological guidance for underweight young women with the aim of optimizing their physique.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Program participation rate, completion rate
Key secondary outcomes
Changes in body composition, energy intake, nutritional status, and mental status due to program effects
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
comprehensive exercise program
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) A female university student in the Matsue Campus of Shimane University.
2) BMI <18.5kg / m2 as a result of regular student health examination.
3) The person has given written consent to participate in the research.
Key exclusion criteria
1) If she has a bleeding-prone disorder or are taking a bleeding-prone drug.
2) If she has a mental illness.
3) When exercise is prohibited by the attending physician due to physical illness.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Sugihara |
Organization
Shimane university
Division name
Health service center
Zip code
6908504
Address
1060 Nishikawtsu-cho, Matsue-city, Shimane
TEL
+81-852-32-6568
shinobutozuito@soc.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Sugihara |
Organization
Shimane university
Division name
Health service center
Zip code
6908504
Address
1060 Nishikawtsu-cho, Matsue-city, Shimane
TEL
+81-852-32-6568
Homepage URL
shinobutozuito@soc.shimane-u.ac.jp
Sponsor or person
Institute
Health service center, Shimane university
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University faculty of Medicine
Address
89-1, Enyacho, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2022 | Year | 07 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055091
