UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034742 |
|---|---|
| Receipt number | R000039284 |
| Scientific Title | Improvements in Physical Functions and healthcare economic evaluation with foot care and exercise in elderly people |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2023/08/18 16:59:22 |
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Basic information
Public title
Improvements in Physical Functions and healthcare economic evaluation with foot care and exercise in elderly people
Acronym
Foot care for Improvements in Physical Functions
Scientific Title
Improvements in Physical Functions and healthcare economic evaluation with foot care and exercise in elderly people
Scientific Title:Acronym
Foot care for Improvements in Physical Functions
Region
| Japan |
Condition
Condition
Elderly
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim to investigate the effect of foot care and exercise on improvement in physical function, activity and medical cost in elderly people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement in lower limb muscle strength for baseline and 5 months
Key secondary outcomes
Foot pressure distribution, questionnaires and medical cost
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Perform foot care once a month
Interventions/Control_2
Perform exercise once a month
Interventions/Control_3
control
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Possibility of walking independently
Communication is possible through conversation
Key exclusion criteria
Subjects for whom we could not obtain a physician's approval
Target sample size
400
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, Chiba City, Chiba, 261-0021, Japan
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, Chiba City, Chiba, 261-0021, Japan
TEL
043-273-1111
Homepage URL
kazuhiko.yamashita@tohto.ac.jp
Sponsor or person
Institute
Tohto University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiki City Office in Saitama Prefecture
Name of secondary funder(s)
Medical Foot care JF Association
IRB Contact (For public release)
Organization
Tohto University
Address
1-1 Hibino, Mihama, Chiba City, Chiba, 261-0021, Japan
Tel
0432731111
kazuhiko.yamashita@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
埼玉県志木市，秋田県潟上市，秋田県三種町
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039284
| Research Plan | |
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| 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 |
