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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006328
Receipt No. R000007441
Scientific Title A randomized control trial for preventing frailty in the community dwelling elderly
Date of disclosure of the study information 2011/09/13
Last modified on 2012/04/19

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Basic information
Public title A randomized control trial for preventing frailty in the community dwelling elderly
Acronym A randomized control trial for preventing frailty in the elderly
Scientific Title A randomized control trial for preventing frailty in the community dwelling elderly
Scientific Title:Acronym A randomized control trial for preventing frailty in the elderly
Region
Japan

Condition
Condition Frailty
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of multidimensional program combining exercise, nutrition and psychosocial interventions on frailty for the frail elderly

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frailty index, Quality of life, TMIG-Index of competence
Key secondary outcomes Physical functions (grip strength, gait performance), Diversity of food intake, Self-efficacy

Base
Study type Interventional

Study design
Basic design Cross-over
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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Providing multidimensional program combining exercise, nutrition and psychosocial interventions for three-month period (22 sessions) -> No intervention
Interventions/Control_2 No intervention -> Providing multidimensional program combining exercise, nutrition and psychosocial interventions for three-month period (22 sessions)
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Living in Hatoyama Town, Saitama Prefecture
2) Participants of Hatoyama Cohort Study
3) Frailty index score of two or above
4) Those who gave written informed consent forms
Key exclusion criteria 1) Participating in health promotion activities routinely
2) Having serious or unstable illness
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Shinkai
Organization Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name Tokyo Metropolitan Institute of Gerontology
Zip code
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Murayama
Organization Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name Tokyo Metropolitan Institute of Gerontology
Zip code
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015 Japan
TEL 03-3964-3241
Homepage URL
Email murayama@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department

Funding Source
Organization Hatoyama Town
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Research Institute of Science and Technology for Society

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 鳩山ふれあいセンター(埼玉県)

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 13 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 No longer recruiting
Date of protocol fixation
2011 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 09 Month 12 Day
Last modified on
2012 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007441

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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