UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023575 |
|---|---|
| Receipt number | R000027153 |
| Scientific Title | Investigation of Taylor-made exercise prescription program considering genetic and environmental factors |
| Date of disclosure of the study information | 2016/08/11 |
| Last modified on | 2018/02/10 09:33:16 |
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Basic information
Public title
Investigation of Taylor-made exercise prescription program considering genetic and environmental factors
Acronym
Taylor-made exercise prescription program
Scientific Title
Investigation of Taylor-made exercise prescription program considering genetic and environmental factors
Scientific Title:Acronym
Taylor-made exercise prescription program
Region
| Japan |
Condition
Condition
Life-style related diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Geriatrics | Adult | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effects of Taylor-made exercise program on the risks of life-style related disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
1) Physical activity
2) Dietary survey
3) Endothelial morphology and function
4) Arterial stiffness
5) Body composition
6) Resting metabolic rate
7) Maximal oxygen consumption and aerobic threshold
8) Blood samples
9) Hormone and genotypes
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
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Physical activity intervention program during a year
Interventions/Control_2
Control
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
| 10 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese men and women
Key exclusion criteria
All participants were excluded if they were pregnant or had cardiovascular disease, cancer, cerebrovascular disease, severe mental disorder, or a physical disability.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Sanada |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
Address
1-1-1 Noji-Higashi, Kusatsu, Shiga, Japan
TEL
077-561-2674
ksanada@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Sanada |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
Address
1-1-1 Noji-Higashi, Kusatsu, Shiga, Japan
TEL
077-561-2674
Homepage URL
ksanada@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
A Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan (#24300239)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 08 | Month | 11 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Furushima T, Miyachi M, Iemitsu M, Murakami H, Kawano H, Gando Y, Kawakami R, Sanada K. Development of prediction equations for estimating appendicular skeletal muscle mass in Japanese men and women. Journal of Physiological Anthropology. 2017 Aug; 36(1)34.
Furushima T, Miyachi M, Iemitsu M, Murakami H, Kawano H, Gando Y, Kawakami R, Sanada K. Comparison between clinical significance of height-adjusted and weight-adjusted appendicular skeletal muscle mass. J Physiol Anthropol. 2017 Feb; 36(1):15.
Management information
Registered date
| 2016 | Year | 08 | Month | 10 | Day |
Last modified on
| 2018 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027153
