UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050086 |
|---|---|
| Receipt number | R000057057 |
| Scientific Title | Development and validation of intervention program for prevention of dementia and quality of life improvement in community-dwelling older adults |
| Date of disclosure of the study information | 2023/01/20 |
| Last modified on | 2024/01/19 16:16:05 |
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Basic information
Public title
Development and validation of intervention program for prevention of dementia and quality of life improvement in community-dwelling older adults
Acronym
Development and validation of intervention program for prevention of dementia and quality of life improvement in community-dwelling older adults
Scientific Title
Development and validation of intervention program for prevention of dementia and quality of life improvement in community-dwelling older adults
Scientific Title:Acronym
Development and validation of intervention program for prevention of dementia and quality of life improvement in community-dwelling older adults
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the combined intervention program developed in this study on cognitive function and quality of life in healthy older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function: Mini-Mental State Examination, Wechsler Memory Scale-Revised, Digit symbol substitution test, Verbal fluency test, Stroop test, Trail making test
Key secondary outcomes
Physical function: Grip Strength, Gait Speed, Timed Chair Stands, 6-minute Walking Test, One-legged Standing Test, Timed Up & Go Test
Psychological function: Geriatric Depression Scale 15, Apathy scale, Life Satisfaction Index-A
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group-based combined intervention with physical and cognitive training for 16 weeks
Interventions/Control_2
Lecture about health (2 times per 16 weeks)
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) More than 21 points on the Mini-Mental State Examination (MMSE)
(2) Having provided a written informed consent on this study
Key exclusion criteria
(1) Requiring long-term care or support
(2) Diagnosed dementia
(3) Diagnosed psychiatric disorders
(4) Moderate or higher visual or hearing impairment
(5) Requiring exercise restrictions
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Taeko |
| Middle name | |
| Last name | Makino |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8824
Homepage URL
taeko.makino.a7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Electric Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 01 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | 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 | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057057
