UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051703 |
|---|---|
| Receipt number | R000058450 |
| Scientific Title | Impacts of Package Intervention Using Exercise, Cognitive Stimulation and Occupations on the Inhibition of Cognitive Functional Decline by in Community-dwelling older people |
| Date of disclosure of the study information | 2023/07/24 |
| Last modified on | 2023/07/24 19:45:57 |
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Basic information
Public title
Impacts of Package Intervention Using Exercise, Cognitive Stimulation and Occupations on the Inhibition of Cognitive Functional Decline by in Community-dwelling older people
Acronym
Occupation-based packaged intervention to prevent cognitive decline
Scientific Title
Impacts of Package Intervention Using Exercise, Cognitive Stimulation and Occupations on the Inhibition of Cognitive Functional Decline by in Community-dwelling older people
Scientific Title:Acronym
Occupation-based packaged intervention to reduce cognitive decline
Region
| Japan |
Condition
Condition
community-dwelling older adult
no specific disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the intervention that packages exercise, cognitive stimulation, and occupations considered important by the individual on reducing cognitive decline in elderly people living in the community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Version of The Montreal Cognitive Assessment (MoCA-J) and logical memory I and II of the Wechsler Memory Scale-Revised (WMS-R)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
Intervention group (package intervention using educational guidance on dementia prevention, exercise, cognitive stimulation, and occupations that individuals consider important)
Interventions/Control_2
Control group (having a usual life)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were: aged at least 65 years and capable of communicating in Japanese.
Key exclusion criteria
The exclusion criteria were: diagnosed with dementia; regularly attending a fitness center; participating in any type of structured exercise program; and having any type of hearing and/or visual impairment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Hbikino, Hbikino-City, Osaka
TEL
072-950-2111
yokoikat@omu.ac.jp
Public contact
Name of contact person
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Hbikino, Habikino-City, Osaka
TEL
072-950-2111
Homepage URL
yokoikat@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Katsushi Yokoi
Funding Source
Organization
Osaka Metropolitan 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
Committee on Research Ethics, Graduate School of Rehabilitation Science, Osaka Metropolitan University
Address
3-7-30 Habikino, Habikino-City,Osaka
Tel
072-950-2111
yokoikat@omu.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
公共施設または民間賃貸施設
Other administrative information
Date of disclosure of the study information
| 2023 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 07 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058450
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
