UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between foot gripping strength and physical function in community-dwelling elderly people
Title of the study (Brief title)	Relationship between foot gripping strength and physical function in community-dwelling elderly people
Region	Japan

Condition
Condition	community-dwelling elderly people
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the possibility that foot-gripping strength is indicative of the prediction of the risk of falls
Basic objectives2	Others
Basic objectives -Others	To investigate the association between foot-gripping strength and other physical function (such as walking and balance ability)
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Foot-gripping strength
Key secondary outcomes	Height, body weight, body mass index(BMI), Muscle strength (grip strength, knee extension force, the trunk), physical ability (time-up-and-go test, functional reach test, one-leg standing duration with vision, 5m maximum walking, backward walking, 3m zigzag walking, bending before long seat body), questionnaire (kihon checklist, mini mental state examination,trail making test )

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	community-dwelling elderly people
Key exclusion criteria	Participants with 1) a deformation or severe pain in the joints of the foot and limb, 2)severe cardiovascular disease, 3)common cold or high blood pressure(180 / 110mmHg or more) on the day of the test, or 5)those who are judged as unsuitable for participation in this study.
Target sample size	160

Research contact person
Name of lead principal investigator	Takahiro Yoshikawa
Organization	Osaka City University Graduate School of Medicine
Division name	Sports Medicine
Address	1-4-3 Asahi-machi Abeno-ku Osaka, 545-8585
TEL	06-6645-3790
Email	tkhr6719@med.osaka-cu.ac.jp

Public contact
Name of contact person	Keiko Harada
Organization	Osaka City University Graduate School of Medicine
Division name	Sports Medicine
Address	1-4-3 Asahi-machi Abeno-ku Osaka, 545-8585
TEL	06-6645-3790
Homepage URL
Email	dodokokh@gmail.com

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 25 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 27 Day
Anticipated trial start date	2016 Year 07 Month 20 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	To measure the following body functions, and investigate the association between foot-gripping strength and physical function. Height, body weight, body mass index(BMI), Muscle strength (grip strength, knee extension force, the trunk), physical ability (time-up-and-go test, functional reach test, one-leg standing duration with vision, 5m maximum walking, backward walking, 3m zigzag walking, bending before long seat body), questionnaire (kihon checklist, mini mental state examination, trail making test )

Management information
Registered date	2016 Year 07 Month 19 Day
Last modified on	2016 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026772