UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047029 |
|---|---|
| Receipt number | R000053652 |
| Scientific Title | Effect of Exercise Interventions in Female College Students. |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2022/02/28 14:17:03 |
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Basic information
Public title
Effect of Exercise Interventions in Female College Students.
Acronym
Effect of Exercise Interventions.
Scientific Title
Effect of Exercise Interventions in Female College Students.
Scientific Title:Acronym
Effect of Exercise Interventions.
Region
| Japan |
Condition
Condition
No applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes in physical activity, body composition, and physical function during school attendance restriction by COVID-19 and the effects of exercise intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in physical activity, body composition, and physical function before and after school attendance restriction by COVID-19.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Normal life activities
Interventions/Control_2
Normal activities of daily living and 30 minutes of exercise per session three times a week (pulse rate 135 beats per minute)
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Eighteen female students (20-22 years old) attending University A in the Kinki region, who had no exercise habit, were selected.
Definition of exercise habit: "Those who exercise for 30 minutes or more at least twice a week and continue to do so for one year or more" as indicated in the National Health and Nutrition Survey.
Key exclusion criteria
Healthy person
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Manami |
| Middle name | |
| Last name | Ogawa |
Organization
Kobe Women's University
Division name
Graduate School of Life Sciences
Zip code
6540088
Address
2-1 Aoyama, Higashisuma, Suma-ku, Kobe City, Hyogo 654-8585, Japan
TEL
0787314416
ogawa-nakano@suma.kobe-wu.ac.jp
Public contact
Name of contact person
| 1st name | Manami |
| Middle name | |
| Last name | Ogawa |
Organization
Kobe Women's University
Division name
Graduate School of Life Sciences
Zip code
6540088
Address
2-1 Aoyama, Higashisuma, Suma-ku, Kobe City, Hyogo 654-8585, Japan
TEL
0787314416
Homepage URL
ogawa-nakano@suma.kobe-wu.ac.jp
Sponsor or person
Institute
Kobe Women's University
Institute
Department
Personal name
Funding Source
Organization
Kobe Women's 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
Kobe Women's University
Address
2-1 Aoyama, Higashisuma, Suma-ku, Kobe City, Hyogo 654-8585, Japan
Tel
0787314416
ogawa-nakano@suma.kobe-wu.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 | 02 | Month | 28 | 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
18
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
| 2020 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 23 | 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 | 02 | Month | 28 | Day |
Last modified on
| 2022 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053652
