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Recruitment status Completed
Unique ID issued by UMIN UMIN000014705
Receipt No. 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 2018/07/10

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Shimada, Hiroyuki
Organization National Center for Geriatrics and Gerontology
Division name Department of Functioning Activation
Zip code
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
Middle name
Last name Lee, Sangyoon
Organization National Center for Geriatrics and Gerontology
Division name Section for Physical Functioning Activation Department of Functioning Activation
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017093


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