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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039390
Receipt No. R000044913
Scientific Title Relationship between change in nursing care level and physical function of elderly in need of nursing care -Two-year follow-up survey of rehabilitation function specialized type users-
Date of disclosure of the study information 2020/02/20
Last modified on 2021/03/21

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Basic information
Public title Relationship between change in nursing care level and physical function of elderly in need of nursing care
-Two-year follow-up survey of rehabilitation function specialized type users-
Acronym Relationship between change in nursing care level and physical function of elderly in need of nursing care
Scientific Title Relationship between change in nursing care level and physical function of elderly in need of nursing care
-Two-year follow-up survey of rehabilitation function specialized type users-
Scientific Title:Acronym Relationship between change in nursing care level and physical function of elderly in need of nursing care
Region
Japan

Condition
Condition Elderly in need of care
Elderly people needing support
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between physical function and change in nursing care level for elderly people requiring support and long-term care who are 75 years or older who have been using day service specialized in rehabilitation function for more than 2 years
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BMI, 5m normal walking time, grip strength, knee extension muscle strength, one leg standing, timed up and go test
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
75 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Elderly people who have been using the day service for more than two years
Key exclusion criteria Elderly people who use the day service for less than 2 years
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Hiromichi
Middle name
Last name Takeda
Organization Kio University
Division name Division of Health Science, Graduate School
Zip code 635-2832
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL 0745-54-1601
Email hiromichi.takeda0608@gmail.com

Public contact
Name of contact person
1st name Hiromichi
Middle name
Last name Takeda
Organization Kio University
Division name Division of Health Science, Graduate School
Zip code 635-2832
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL 0745-54-1601
Homepage URL
Email hiromichi.takeda0608@gmail.com

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio 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 Kio University
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
Tel 0745-54-1602
Email soumu@kio.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

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 20 Day

Related information
URL releasing protocol http://jgs62.umin.jp/
Publication of results Published

Result
URL related to results and publications http://jgs62.umin.jp/
Number of participants that the trial has enrolled 154
Results After 2 years of follow-up, 30 patients (19.5%) in the improvement group and 124 patients (80.5%) in the maintenance and worsening group required nursing care. As a result of logistic regression analysis with improvement in the level of care required as the dependent variable, 5m normal walking time (OR 0.87, 95%CI: 0.76-0.98) and knee joint extension muscle strength (OR 1.08, 95%CI: 1.00-1.16) were extracted as independent related factors.
Results date posted
2021 Year 03 Month 21 Day
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
2019 Year 12 Month 01 Day
Date of IRB
2020 Year 05 Month 29 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Change in nursing care required for 2 years, BMI, 5m normal walking time, grip strength, knee extension muscle strength, one leg standing, TUG

Management information
Registered date
2020 Year 02 Month 04 Day
Last modified on
2021 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044913

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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