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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023191
Receipt No. R000026701
Scientific Title The effects of the intervention to the domestic role for the frail elderly
Date of disclosure of the study information 2016/08/15
Last modified on 2019/01/16

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Basic information
Public title The effects of the intervention to the domestic role for the frail elderly
Acronym The effects of the intervention to the domestic role for the frail elderly
Scientific Title The effects of the intervention to the domestic role for the frail elderly
Scientific Title:Acronym The effects of the intervention to the domestic role for the frail elderly
Region
Japan

Condition
Condition Frail elderly people
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effects of interventions by the domestic role for frail elderly people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes the number of steps taken before and
after intervention(6weeks,12weeks)
Key secondary outcomes grip strength
Timed up & go test
Short Physical Performance Battery
muscle strength of knee extension
Geriatric Depression Scale 5(GDS5)
Modified Falls Efficacy Scale(MFES)
Functional Independence Measure(FIM)
Life-space Assessment(LSA)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Usual care and Domestic role
Interventions/Control_2 Usual care and Exercise
Interventions/Control_3 Usual care
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 Frail elderly people at a day care center
Certified as requiring support level 2 or long-term care level 1 or 2 in their long-term care insurance
Key exclusion criteria No self-reliance of indoor walking
MMSE<24
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Suguru Ando
Organization Aino university
Division name Department of Physical Therapy , Faculty of Health Science
Zip code
Address 4-5-4, Higashioda Ibaraki city Osaka
TEL 072-627-1711
Email s-ando@pt-u.aino.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Higuchi
Organization Osaka Prefecture University
Division name Graduate School of Comprehensive Rehabilitation
Zip code
Address 3-7-30,Habikino,Habikino city
TEL 0729-950-2111
Homepage URL
Email yumi@rehab.ssakafu-u.ac.jp

Sponsor
Institute Osaka Prefecture University
Institute
Department

Funding Source
Organization Osaka Prefecture University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 特別養護老人ホーム高寿園デイサービスセンター(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 15 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 15 Day
Last modified on
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026701

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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