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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033489
Receipt No. R000038190
Scientific Title Sutady of the program development of exercise and care that brings positive feelings to the cognitive function of elderly people
Date of disclosure of the study information 2018/07/24
Last modified on 2019/07/25

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Basic information
Public title Sutady of the program development of exercise and care that brings positive feelings to the cognitive function of elderly people
Acronym Sutady of the program development of exercise and care that brings positive feelings to the cognitive function of elderly people
Scientific Title Sutady of the program development of exercise and care that brings positive feelings to the cognitive function of elderly people
Scientific Title:Acronym Sutady of the program development of exercise and care that brings positive feelings to the cognitive function of elderly people
Region
Japan

Condition
Condition Frail elderly people
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the research is to address the body recognition function of the assignment type balance gates
Impact, reveal the changes in walking ability, physical function, cognitive function, performing 6 months intervention. Next, by positive emotional care intervention, verify the judgment on the effect on social behavior, cognitive processing, problem solving ability. We will develop a cognitive decline prevention program that can be continued individually.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation items measure salivary cortisol secretion with physical activity test for elderly as a physical function evaluation, Mini-Mental State Examination as cognitive function evaluation, psycho-psychological function evaluation.

























Evaluation items measure salivary cortisol secretion with physical activity test for elderly as a physical function evaluation, Mini-Mental State Examination as cognitive function evaluation, psycho-psychological function evaluation.










Evaluation items measure salivary cortisol secretion with physical activity test for elderly as a physical function evaluation, Mini-Mental State Examination as cognitive function evaluation, psycho-psychological function evaluation.
























Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 The intervention is to perform the assignment type balance gates twice a week, for 6 months.
Interventions/Control_2 The intervention is carried out twice a week for tactile care and for 6 months.
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
101 years-old >
Gender Male and Female
Key inclusion criteria We are targeting frail elderly people aged 65 and older living at home.
Key exclusion criteria Exclude cared persons by nursing care insurance system.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name kimura
Middle name kimura
Last name Kimura Hiromi
Organization Fukuoka University
Division name Faculty of Medicine
Zip code 814-0180
Address 7 - 45 - 1 Nagakuma, Seongnam-gu, Fukuoka city, Fukuoka prefecture
TEL 092-801-1011
Email kimurah@adm.fukuoka-u.ac.jp

Public contact
Name of contact person
1st name hiromi
Middle name hiromi814
Last name Kimura Hiromi
Organization Fukuoka University
Division name Faculty of Medicine
Zip code 814-0180
Address 7 - 45 - 1 Nagakuma, Seongnam-gu, Fukuoka city, Fukuoka prefecture
TEL 092-801-1011
Homepage URL https://www.fukuoka-u.ac.jp/
Email kimurah@adm.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukuoka University
Address 8-19-1 Nanakuma, Jonan-ku Fukuoka 814-0180, JAPAN
Tel 092-801-1011
Email kimurah@adm.fukuoka.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
2018 Year 07 Month 24 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 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
2018 Year 07 Month 24 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038190

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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