UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010502 |
|---|---|
| Receipt number | 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 12:30:39 |
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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
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
d.uritani@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012281
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
