UMIN-CTR Clinical Trial

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
Email	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
Email	ogawa-nakano@suma.kobe-wu.ac.jp

Sponsor
Institute	Kobe Women's University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053652