UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023234 |
|---|---|
| Receipt number | 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 18:57:29 |
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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
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
dodokokh@gmail.com
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026772
