UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002196