UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of toe grip strength training on fall prevention in elderly
Title of the study (Brief title)	Effect of toe grip strength training
Region	Japan

Condition
Condition	facility elderly
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of study is to investigate the effect of toe grip strength training on fall prevention in elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement in toe grip strength
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
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	Toe grip strength training
Interventions/Control_2	Non-Toe grip strength training
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	65 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1)Japanese 2)Age>=65 years 3)Informed consent provided 4)Able to follow the instructions of the study team
Key exclusion criteria	1)The person that understanding and an agreement are not provided by the person for participation of the final examination. 2)The patient whom it was judged an examination responsibility doctor or an examination allotment doctor to be inappropriate as a subject.
Target sample size	60

Research contact person
Name of lead principal investigator	Yutaka Kimura
Organization	Kansai Medical University
Division name	Health science
Address	Hirakata,Osaka Shinmachi 2-5-1
TEL	072-804-0101
Email	drkimura@alles.or.jp

Public contact
Name of contact person	Ryota Tsuyuguchi
Organization	Kansai Medical University
Division name	Health science
Address	Hirakata,Osaka Shinmachi 2-5-1
TEL	072-804-0101
Homepage URL
Email	tsuyu@cnt.osaka-sandai.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	Self-funding and individual research expenses
Organization
Division
Category of Funding Organization	Self funding
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	軽費老人ホームヴィラ城陽（京都府）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 05 Month 25 Day
Anticipated trial start date	2017 Year 05 Month 26 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 22 Day
Last modified on	2018 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031436