UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043428 |
|---|---|
| Receipt number | R000049398 |
| Scientific Title | Building an online comprehensive exercise program for underweight female university students, a pilot study |
| Date of disclosure of the study information | 2021/02/24 |
| Last modified on | 2024/08/28 11:12:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Building an online comprehensive exercise program for underweight female university students, a pilot study
Acronym
Building an online comprehensive exercise program for underweight female university students, a pilot study
Scientific Title
Building an online comprehensive exercise program for underweight female university students, a pilot study
Scientific Title:Acronym
Building an online comprehensive exercise program for underweight female university students, a pilot study
Region
| Japan |
Condition
Condition
underweight female university students
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to assess tolerability to build a sustainable online comprehensive exercise program for underweight female university students.
Basic objectives2
Others
Basic objectives -Others
In underweight female university students, (1) assess physical and mental health, and (2) identify program participation rates and problems.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Program participation rate and problems
Key secondary outcomes
(1)Prevalence of physical and mental illness in underweight students
(2)Changes in energy intake, nutritional status, mental status, and body composition with the program
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
60 minutes each, 10 sessions
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 Shimane University, Matsue Campus.
2) Underweight (BMI <18.5kg/m2)
3)Who have expressed their consent to the study.
Key exclusion criteria
1)Who is suspected of anorexia nervosa requiring specialist treatment in the screening test before registration
2)Who has a blood disorder or has taking bleeding drugs (antiplatelet drugs, anticoagulants, etc.).
3)Who has a mental illness.
4)Exercise is prohibited by the physician due to physical illness.
Target sample size
30
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
690-8504
Address
1060 Nishikawatsu, Matsue city, Shimane
TEL
0852-32-6568
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
690-8504
Address
1060 Nishikawatsu, Matsue city, Shimane
TEL
0852-32-6568
Homepage URL
shinobutozuito@soc.shimane-u.ac.jp
Sponsor or person
Institute
Health service center in Shimane university
Institute
Department
Personal name
Funding Source
Organization
Health service center in Shimane 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
Health service center in Shimane university
Address
1060 Nishikawatsu, Matsue city, Shimane
Tel
0852-32-6568
shinobutozuito@soc.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
| 2021 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
https://health.shimane-u.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
https://health.shimane-u.ac.jp/
Number of participants that the trial has enrolled
35
Results
The subjects were 35 underweight female university students, characterized by marked low activity levels and low skeletal muscle mass. The program participation rate was approximately 60%, lower than expected, and it was deemed necessary to modify the program. There was a desire to increase the variety of exercises and include shorter videos as areas for improvement in the program. This is a pilot study, and the program has been modified based on these results before commencing this research.
Results date posted
| 2024 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were female undergraduate students affiliated with our university who were underweight and had a BMI of <18.5 kg/m2.
Participant flow
Subjects were recruited during regular student health checkups, and later explained the situation in person by a doctor. Subjects were excluded if they were deemed to require treatment at a medical institution, if exercise therapy was deemed dangerous, if they had a disease that made them prone to bleeding or were taking medication, or if they were undergoing treatment for an illness that prohibited them from exercising. Subjects who agreed to the study were registered in the web system as program participants, and participated in the program online.
Adverse events
none
Outcome measures
Primary outcome: Program participation rate, program problems
Secondary outcome: Body composition (BMI, skeletal muscle mass)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 24 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049398
