UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001842 |
|---|---|
| Receipt number | R000002196 |
| Scientific Title | Interdisciplinary Approach to Gerontology Research for Successful Aging in a Rapidly Aging Society |
| Date of disclosure of the study information | 2009/04/10 |
| Last modified on | 2022/10/15 11:53:15 |
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Basic information
Public title
Interdisciplinary Approach to Gerontology Research for Successful Aging in a Rapidly Aging Society
Acronym
Tokyo Oldest Old Survey on Total Health
(TOOTH)
Scientific Title
Interdisciplinary Approach to Gerontology Research for Successful Aging in a Rapidly Aging Society
Scientific Title:Acronym
Tokyo Oldest Old Survey on Total Health
(TOOTH)
Region
| Japan |
Condition
Condition
geriatric syndrome, frailty, nutrition, oral health, mental health
Classification by specialty
| Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to explore what happens to physical, mental, and oral health in the oldest old and to investigate factors that influence their health and health maintenance.
Basic objectives2
Others
Basic objectives -Others
The specific aims are:
1) To investigate determinants of age-related functional decline and mortality, incorporating a newly-developed risk-scoring system from a centenarians study.
2) To assess to what extent healthy behavior and lifestyle contribute to maintain function and physiological reserve.
3) To examine the association between oral health and functional decline, especially in relation with musculoskeletal function and nutritional status.
4) To quantify pathologies associated with functional decline and mortality, assessed using non-invasive techniques.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
all-cause mortality, functional decline, QOL
Key secondary outcomes
institutionalization, geriatric syndrome
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
| 85 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The base population for the study participants was comprised of male and female inhabitants aged 85 years or older in the heart of the Tokyo Metropolitan area
Key exclusion criteria
severely ill, severe dementia
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasumichi Arai |
Organization
Keio University School of Medicine
Division name
Center for Supercentenarian Researchicine
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
yasumich@z6.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasumichi Arai |
Organization
Keio University School of Medicine
Division name
Center for Supercentenarian Research
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
http://web.sc.itc.keio.ac.jp/medicine/rounen/research/cat3/post-6.html
yasumich@z6.keio.jp
Sponsor or person
Institute
Center for Supercentenarian Research, Keio University School ofMedicine
Institute
Department
Personal name
Funding Source
Organization
Differing Fields Collaboration Grant, the Center for Research Promotion's Grant Programs for Researchers, Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Complete Denture Prosthodontics, Nihon University School of Dentistry
Name of secondary funder(s)
Grant-in-Aid for Scientific Research (C)
Institute for Food and Health Science, Yazuya Co. Ltd
The Univers Foundation
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://web.sc.itc.keio.ac.jp/medicine/rounen/research/cat3/2009-1.html
Number of participants that the trial has enrolled
Results
The results from the pilot study is being submitted to Geriaatr Gerontol Inters.
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
Main results already published
Date of protocol fixation
| 2008 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2007 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 01 | Day |
Other
Other related information
. The interview collected detailed information on sociodemographic data, subjective health, lifestyle, well-being assessed with the Philadelphia Geriatric Center Morale scale (PGC), cognitive function assessed with the mini-mental state examination (MMSE), social network and support, basic activities of daily living (BADL) and instrumental ADL (IADL), visual and hearing impairment, and usage of electrical home appliances. The medical examination included medical history, falls and incontinence, physical and cognitive activities, general pain and bowel habits, physical examination, anthropometric measurement, physical function including grip strength in the dominant hand, timed-up and go test, one-leg standing, repeated chair standing from a sitting position, and 12-leads electrocardiogram. The dental interview included a questionnaire about oral health care, an index of QOL for oral function, food intake, and food acceptance (15 test foods). The dental health examination included degree of mouth cleaning and periodontal disease, condition of the temporomandibular joint, number and condition of remaining teeth, the condition of dental prosthesis, the bite force, and masticatory ability.
Management information
Registered date
| 2009 | Year | 04 | Month | 02 | Day |
Last modified on
| 2022 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002196
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
