UMIN-CTR Clinical Trial

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)
Email	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
Email	sylee@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017093