UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001842
Receipt No. 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 2014/05/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yasumich@z6.keio.jp

Sponsor
Institute Center for Supercentenarian Research, Keio University School ofMedicine
Institute
Department

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
Email

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 No longer recruiting
Date of protocol fixation
2008 Year 02 Month 14 Day
Date of IRB
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
2014 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002196

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.