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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023234
Receipt No. R000026772
Scientific Title Relationship between foot gripping strength and physical function in community-dwelling elderly people
Date of disclosure of the study information 2016/07/25
Last modified on 2016/07/19

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Basic information
Public title Relationship between foot gripping strength and physical function in community-dwelling elderly people
Acronym Relationship between foot gripping strength and physical function in community-dwelling elderly people
Scientific Title Relationship between foot gripping strength and physical function in community-dwelling elderly people
Scientific Title:Acronym 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 )


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

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
1st name
Middle name
Last name Takahiro Yoshikawa
Organization Osaka City University Graduate School of Medicine
Division name Sports Medicine
Zip code
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
1st name
Middle name
Last name Keiko Harada
Organization Osaka City University Graduate School of Medicine
Division name Sports Medicine
Zip code
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

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)

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
2016 Year 07 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 27 Day
Date of IRB
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

Other
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

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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