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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010502
Receipt No. R000012281
Scientific Title Effects of the program to improve physical fitness for preschool kids
Date of disclosure of the study information 2013/04/16
Last modified on 2015/04/20

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Basic information
Public title Effects of the program to improve physical fitness for preschool kids
Acronym Effects of the program to improve physical fitness for preschool kids
Scientific Title Effects of the program to improve physical fitness for preschool kids
Scientific Title:Acronym Effects of the program to improve physical fitness for preschool kids
Region
Japan

Condition
Condition Healthy preschool kids aged 4 to 6 years
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation about effect of the program to improve physical fitness for prescool kids
Basic objectives2 Others
Basic objectives -Others Investigation about effect of the program to improve physical fitness for preschool kids that consists of exercise program in daycare or kindergarten and instructional program about exercise, diet and nutrition for parents
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Outcomes of measurement of physical fitness (hand grip strength, sitting trunk flexion, toe grip strength, 25m run, tennis ball throw, modified shuttle run)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 6-month exercise program in kindergarten or daycare, two instruction seminars about exercise and physical fitness, and diet and nutrion of children for parents.
Interventions/Control_2 No intervention
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
4 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria Healthy preschool children in kindergarten or daycare
Key exclusion criteria Childeren with severe musculoskeletal dysfunction and developmental disability
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Uritani
Organization Kio University
Division name Department of Physical Therapy, Faculty of Health Science
Zip code
Address 4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara prefecture
TEL 0745-54-1601
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Uritani
Organization Kio University
Division name Department of Physical Therapy, Faculty of Health Science
Zip code
Address
TEL
Homepage URL
Email d.uritani@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio 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
Address
Tel
Email

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
2013 Year 04 Month 16 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 Terminated
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 15 Day
Last modified on
2015 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012281

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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