UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and evaluation of a walking function support program aimed at improving physical and mental functions of elderly people residing in a snowy area
Title of the study (Brief title)	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	Shizuko Omote
Organization	Kanazawa University
Division name	Faculty of Health Science
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	Shizuko Omote
Organization	Kanazawa University
Division name	Faculty of Health Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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