UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019562 |
|---|---|
| Receipt number | R000022609 |
| Scientific Title | About the relation between the sarcopenia and a fall in care-needing elderly people. |
| Date of disclosure of the study information | 2015/10/29 |
| Last modified on | 2021/05/07 23:23:59 |
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Basic information
Public title
About the relation between the sarcopenia and a fall in care-needing elderly people.
Acronym
About the relation between the sarcopenia and a fall in care-needing elderly people.
Scientific Title
About the relation between the sarcopenia and a fall in care-needing elderly people.
Scientific Title:Acronym
About the relation between the sarcopenia and a fall in care-needing elderly people.
Region
| Japan |
Condition
Condition
The elderly people aged 65 and over who certification of needed support.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study clarify about the characteristic of a fall and a walk by the existence of sarcopenia in care-needing elderly people.
Basic objectives2
Others
Basic objectives -Others
Surveillance study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
basic information(age,sex,history of present illness,case or medical history,a complication,nursing level),grip,10m-usually walking speed,skeletal muscle mass,characteristic of gait,fall history,lower limb muscle,MMSE,FIM
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The elderly people aged 65 and over who Certification of Needed Support to whom the walk has become independent (include use of a cane).
Key exclusion criteria
1.Those for whom it is difficult to receive a biological impedance method by a cardiac pacemaker etc.
2.A person with the past of apoplexy.
3.The person under sudden trauma medical treatment.
4.The score of MMSE are a person of 21 or less points.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kato Kota |
Organization
Syutaikai hospital
Division name
Home healthcare and welfare facilities
Zip code
Address
8-1, Shirokita-cho, Yokkaichi-shi, Mie-ken
TEL
059-354-1771
tuusyo-syu@syutaikai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kato Kota |
Organization
Syutaikai hospital
Division name
Home healthcare and welfare facilities
Zip code
Address
8-1, Shirokita-cho, Yokkaichi-shi, Mie-ken
TEL
059-354-1771
Homepage URL
tuusyo-syu@syutaikai.jp
Sponsor or person
Institute
Syutaikai hospital
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
| 2015 | Year | 10 | Month | 29 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design:cross-sectional study
Method of recruiting subjects:Between October 19, 2015 - 2017 the end of March, a person who was using our facilities and outpatient rehabilitation, and those who meet the selection criteria.
Measurement item:basic information,grip,10m-usually walking speed,skeletal muscle mass,characteristic of gait,fall history,lower limb muscle,MMSE,FIM
Management information
Registered date
| 2015 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022609
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
