UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013927 |
|---|---|
| Receipt number | R000016239 |
| Scientific Title | Comparison of the fall frequency of sarcopenia and dynapenia in frail older adults-from follow-up one year |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2014/06/15 13:51:14 |
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Basic information
Public title
Comparison of the fall frequency of sarcopenia and dynapenia in frail older adults-from follow-up one year
Acronym
Comparison of the fall frequency of sarcopenia and dynapenia in frail older adults-from follow-up one year
Scientific Title
Comparison of the fall frequency of sarcopenia and dynapenia in frail older adults-from follow-up one year
Scientific Title:Acronym
Comparison of the fall frequency of sarcopenia and dynapenia in frail older adults-from follow-up one year
Region
| Japan |
Condition
Condition
sarcopenia, dynapenia, frailty
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the frail elderly, Dynapenia determination using the decision algorithm of Dynapenia advocated by Manini and Sarcopenia determination using the decision algorithm by Asia Working Group for Sarcopenia, and comparison of the frequency of falling one year after the judgment by each.
Basic objectives2
Others
Basic objectives -Others
Validation of sarcopenia determination using the algorithm of AWGS
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skeletal muscle mass, muscle strength, physical function, fall score, frailty scale
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
frail elderly
Key exclusion criteria
the person who exhibit significant physical disability, significant dementia, heart disease, malignant tumor and digestive organ disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | masaki iwamura |
Organization
Graduate school of health science, kio university
Division name
division of health science
Zip code
Address
4-2-2, umaminaka, kouryou, kitakatsuragi, Nara
TEL
0745-54-1601
miwamura-creha@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masaki iwamura |
Organization
Graduate school of health science, kio university
Division name
division of health science
Zip code
Address
4-2-2, umaminaka, kouryou, kitakatsuragi, Nara
TEL
0745-54-1601
Homepage URL
miwamura-creha@umin.ac.jp
Sponsor or person
Institute
Graduate school of health science, kio university
Institute
Department
Personal name
Funding Source
Organization
Graduate school of health science, kio university
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
for people that are determined to be dynapenia and people that determined to sarcopenia in the frail elderly, and one year follow-up and fall times.
Management information
Registered date
| 2014 | Year | 05 | Month | 12 | Day |
Last modified on
| 2014 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016239
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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