UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033489 |
|---|---|
| Receipt number | 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 10:53:10 |
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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
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/
kimurah@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038190
