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Name:
UMIN ID:

Recruitment status Completed
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 2019/12/27

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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 Suguru
Middle name
Last name Ando
Organization Aino university
Division name Department of Physical Therapy , Faculty of Health Science
Zip code 567-0122
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 Yumi
Middle name
Last name Higuchi
Organization Osaka Prefecture University
Division name Graduate School of Comprehensive Rehabilitation
Zip code 583-0855
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 Osaka Prefecture University
Address 3-7-30 Habikino, Habikino-shi, Osaka
Tel 0726271711
Email yumi@rehab.ssakafu-u.ac.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 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 https://journals.humankinetics.com/view/journals/japa/japa-overview.xml
Publication of results Published

Result
URL related to results and publications https://journals.humankinetics.com/view/journals/japa/japa-overview.xml
Number of participants that the trial has enrolled 36
Results
Over the 12 weeks, the number of steps in the CDR group increased incrementally. However, the step count in the HE group did not change significantly, and the step count in the CON group decreased gradually. The rates of change in each group at six and 12 weeks were 22.8% and 25.3% for the CDR group, -3.7% and 0.4% for the HE group, and -2.8% and -21.9% for the CON group. 
Results date posted
2019 Year 12 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were recruited from three centers, of which two are in Osaka prefecture and the other is in Shiga prefecture. Inclusion criteria were as follows: aged 65 years or older, able to walk indoors by themselves (regardless of the use of auxiliary tools), able to understand the purpose of the study, and providing consent. Exclusion criteria were as follows: pacemaker implantation and Mini-Mental State Examination (MMSE) score under 24.
Participant flow
Participants meeting the criteria were assigned to three groups, namely custom-made daily routine intervention (CDR), home-based exercise intervention (HE), and control (CON) according to their days of attending the day care center. Based on the results of a draw performed by a person uninvolved in the study, we defined the CDR group as those who attended the center on Wednesday or Saturday, the HE group as those who attended on Tuesday or Friday, and the CON group as those who attended on the remaining days. If there were participants who attended on multiple days, the independent person allocated them randomly. 
Adverse events
One participant in the CDR group experienced irritation on her back while wearing the accelerometer. Although there were no abnormal findings on the skin, we followed the request of the participant and withdrew her from the study. One participant in the CON group experienced irritation on the wrist because of the accelerometer. When the participant removed the band and briefly massaged the area the irritation stopped, and she immediately placed the band back on her wrist. 
Outcome measures
For the objective measurement of number of steps, the primary outcome, we used a wrist-worn three-axis accelerometer (UP2, Jawbone Inc., San Francisco, CA) and measured the number of steps in 24 hours for eight days. As secondary incidental outcomes, we evaluated activities of daily living (ADL) and physical functions. For ADL we used the Functional Independence Measure (FIM; Granger, Hamilton, Linacre, Heinemann, & Wright, 1993). For the physical function evaluation, we performed knee extension muscle strength evaluations and the Timed Up and Go (TUG) test. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 01 Month 22 Day
Anticipated trial start date
2016 Year 08 Month 25 Day
Last follow-up date
2018 Year 05 Month 31 Day
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 12 Month 27 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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