UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029632 |
|---|---|
| Receipt number | R000033853 |
| Scientific Title | Development and evaluation of a walking function support program aimed at improving physical and mental functions of elderly people residing in a snowy area |
| Date of disclosure of the study information | 2017/10/23 |
| Last modified on | 2017/10/19 20:33:17 |
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Basic information
Public title
Development and evaluation of a walking function support program aimed at improving physical and mental functions of elderly people residing in a snowy area
Acronym
Development and evaluation of a walking function support program
Scientific Title
Development and evaluation of a walking function support program aimed at improving physical and mental functions of elderly people residing in a snowy area
Scientific Title:Acronym
Development and evaluation of a walking function support program
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a foot-care awareness program designed to improve foot morphology, physical functioning, and fall prevention among the community-dwelling elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
foot morphology,
Key secondary outcomes
plantar pressure
physical function, fall prevention,
number of foot steps, foot care
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
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
A 90-minute lecture/practice session was held weekly for two continuous weeks. Session one explained foot structure and function and practiced foot-care. Session two explained foot-care techniques and included a further practice session. Foot-care techniques were a combination of existing methods. Participants performed foot care at least weekly. The intervention duration is 6 months.
Interventions/Control_2
We offered all members of the control group the full foot-care program at the end of the study
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy individuals aged 60 and over who required no support for daily living, and could carry out their own foot care.
The subjects who participated the program habitually and preserve the protocol.
Key exclusion criteria
Those who did not obtain consent to participate in the research.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shizuko Omote |
Organization
Kanazawa University
Division name
Faculty of Health Science
Zip code
Address
5-11-80 Kodatsuno, Kanazawa,Ishikawa
TEL
076-265-2500-2568
omotes@mhs.mp.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shizuko Omote |
Organization
Kanazawa University
Division name
Faculty of Health Science
Zip code
Address
5-11-80 Kodatsuno, Kanazawa,Ishikawa
TEL
076-265-2500-2568
Homepage URL
omotes@mhs.mp.kanazawa-u.ac.jp
Sponsor or person
Institute
Faculty of Health Science, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
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 | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 16 | 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 | 10 | Month | 19 | Day |
Last modified on
| 2017 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033853
