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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029632
Receipt No. 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

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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
Email 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
Email omotes@mhs.mp.kanazawa-u.ac.jp

Sponsor
Institute Faculty of Health Science, Kanazawa University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033853

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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