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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029296
Receipt No. R000033386
Scientific Title Development of gene-based exercise and nutrition program for preventing locomotive syndrome
Date of disclosure of the study information 2017/10/01
Last modified on 2018/09/27

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Basic information
Public title Development of gene-based exercise and nutrition program for preventing locomotive syndrome
Acronym Development of gene-based exercise and nutrition program for preventing locomotive syndrome: GENEFITT trial
Scientific Title Development of gene-based exercise and nutrition program for preventing locomotive syndrome
Scientific Title:Acronym Development of gene-based exercise and nutrition program for preventing locomotive syndrome: GENEFITT trial
Region
Japan Asia(except Japan)

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To develop and investigate the feasibility of gene-based exercise and nutrition program for preventing locomotive syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fat free mass (Time Frame: change from baseline at 12 weeks)
Key secondary outcomes 1) Anthropometric parameters (weight, body fat)
2) Blood pressure
3) Muscle function (timed up and go test, grip strength)
4) Questionnaire (Osteoarthritis Index, Locomotion Check, Constipation score, Healthy lifestyle behaviors, Satisfaction)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Gene-based exercise and nutrition program during 12 weeks
Interventions/Control_2
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
40 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1) Subjects with 40-69 age
2) Male and Female
3) Provided written consent to participate in this study
Key exclusion criteria 1) Subjects who can't exercise therapy
2) Ongoing participation in other clinical trials or research
3) Subjects who are inappropriate for this study determined by the research team.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kawata Shigeji
Organization Northern Lights Corporation
Division name Northern Lights Corporation
Zip code
Address 373-30 Horike-cho, Higashiyama-ku, Kyoto 605-0038, Japan
TEL +81-75-692-3465
Email kawata@terrsa-fitness.com

Public contact
Name of contact person
1st name
Middle name
Last name Kawata Shigeji
Organization Northern Lights Corporation
Division name Northern Lights Corporation
Zip code
Address 373-30 Horike-cho, Higashiyama-ku, Kyoto 605-0038, Japan
TEL +81-75-692-3465
Homepage URL
Email kawata@terrsa-fitness.com

Sponsor
Institute Northern Lights Corporation
Institute
Department

Funding Source
Organization Northern Lights Corporation
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 10 Month 01 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 Completed
Date of protocol fixation
2017 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 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
2017 Year 09 Month 26 Day
Last modified on
2018 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033386

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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