UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037694 |
|---|---|
| Receipt number | R000042992 |
| Scientific Title | A prospective cohort study of physical function and economic analysis by walking monitoring |
| Date of disclosure of the study information | 2019/08/20 |
| Last modified on | 2024/02/18 09:39:28 |
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Basic information
Public title
A prospective cohort study of physical function and economic analysis by walking monitoring
Acronym
A prospective cohort study of physical function and economic analysis by walking monitoring
Scientific Title
A prospective cohort study of physical function and economic analysis by walking monitoring
Scientific Title:Acronym
A prospective cohort study of physical function and economic analysis by walking monitoring
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate daily physical activity and chronic diseases, foot features, medical expenses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in medical expenses
Key secondary outcomes
1. Disease incidence
2. Physical assessment (lower limb muscle strength, balance function, morphological evaluation of the foot, body composition)
3. Blood data
4. Dementia incidence
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
Activity meter(+), Activity meter(-)
Interventions/Control_2
Activity meter(+), Activity meter(-)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person who obtained informed consent
Key exclusion criteria
Individuals with difficulty standing or walking
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Yamashita |
Organization
Tohto University
Division name
Faculty of Human Care at Makuhari
Zip code
261-0021
Address
1-1 Hibino, Mihama-ku, Chiba-city, Chiba
TEL
043-273-1111
kazuhiko.yamashita@tohto.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Yamashita |
Organization
Tohto University
Division name
Faculty of Human Care at Makuhari
Zip code
261-0021
Address
1-1 Hibino, Mihama-ku, Chiba-city, Chiba
TEL
043-273-1111
Homepage URL
kazuhiko.yamashita@tohto.ac.jp
Sponsor or person
Institute
Tohto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society For the Promotion of the Science
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
Tohto University
Address
1-1 Hibino, Mihama-ku, Chiba-city, Chiba
Tel
043-273-1111
maiko.horie@tohto.ac.jp
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
志木市(埼玉県)，上山市(山形県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 20 | 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
3000
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042992
