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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023575
Receipt No. 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

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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
Email 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
Email ksanada@fc.ritsumei.ac.jp

Sponsor
Institute Ritsumeikan University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027153

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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