UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014705 |
|---|---|
| Receipt number | R000017093 |
| Scientific Title | Effects of a comprehensive intervention program to improve physical function, nutritional status, and oral health in the frail elderly persons: A randomized controlled trial |
| Date of disclosure of the study information | 2014/07/29 |
| Last modified on | 2021/05/20 10:19:39 |
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Basic information
Public title
Effects of a comprehensive intervention program to improve physical function, nutritional status, and oral health in the frail elderly persons: A randomized controlled trial
Acronym
Effects of a comprehensive intervention program in the frail elderly persons
Scientific Title
Effects of a comprehensive intervention program to improve physical function, nutritional status, and oral health in the frail elderly persons: A randomized controlled trial
Scientific Title:Acronym
Effects of a comprehensive intervention program in the frail elderly persons
Region
| Japan |
Condition
Condition
Frail elderly adults who had high risks of functional decline (Participants were identified using self-reported survey)
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of comprehensive intervention program to improve physical function, nutritional status, and oral health in the frail elderly persons.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function: MMSE, digit span, modified digit symbol substitution test, modified trail making test
Key secondary outcomes
Physical function: muscle strength, gait, balance
Life function: Index of instrumental activities of daily living, fall experience
Psychological function: QOL, depression (GDS), ,pain, social skill, self-efficacy
Activity level: Life-space assessment, social activity, steps and physical activity, social network
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Comprehensive program to improve physical function, nutritional status, and oral health
Interventions/Control_2
Control group: Non-intervention
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
1) People who were certified as the subjects of secondary prevention in self-reported general geriatric assessment (Kihon Check-list) developed by Ministry of Health, Labour and Welfare of Japan
2) People aged 65years and over and living in Obu city
3) Give a written informed consent to the participation in the present study
Key exclusion criteria
1) Have serious or unstable illnesses
2) Have difficulty in gait
3) Participant in other studies
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology, Center for Gerontology and Social Science
Zip code
4748511
Address
35 Gengo, Morioka-machi, Obu, Aichi, 474-8511, Japan
TEL
0562-44-5651(5611)
shimada@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Sangyoon |
| Middle name | |
| Last name | Lee |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology, Center for Gerontology and Social Science
Zip code
4748511
Address
35 Gengo, Morioka-machi, Obu, Aichi, 474-8511, Japan
TEL
0562445651(5634)
Homepage URL
sylee@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research and Medical Division, National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho Obu Aichi Japan
Tel
0562-46-2311
yaday@ncgg.go.jp
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
大府市内の施設
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
| 2014 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 29 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017093
