UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029296 |
|---|---|
| Receipt number | 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 12:50:21 |
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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
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
kawata@terrsa-fitness.com
Sponsor or person
Institute
Northern Lights Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033386
| 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 |
