UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036340 |
|---|---|
| Receipt number | R000041407 |
| Scientific Title | The effect of cognitive issues on cognitive function and life function of the elderly in the community |
| Date of disclosure of the study information | 2019/04/25 |
| Last modified on | 2020/03/30 09:30:15 |
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Basic information
Public title
The effect of cognitive issues on cognitive function and life function of the elderly in the community
Acronym
The effect of cognitive issues on cognitive function and life function of the elderly in the community
Scientific Title
The effect of cognitive issues on cognitive function and life function of the elderly in the community
Scientific Title:Acronym
The effect of cognitive issues on cognitive function and life function of the elderly in the community
Region
| Japan |
Condition
Condition
Community-dwelling Elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of cognitive problems created for the maintenance and improvement of cognitive function on cognitive function and life function of the elderly in healthy regions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Montreal Cognitive Assessment-Japan;MoCA-J
Before and after 12 weeks of assignment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
We conducted 10-15 minutes a day for 12 weeks. Check the implementation status of the issue every week.
Interventions/Control_2
Control:Only the front and back evaluation is carried out.
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
An elderly person who is 65 years of age or older who is independent of ADL in indoor and outdoor
Key exclusion criteria
A person who has a diagnosis of dementia and is taking medication
Persons participating in other intervention studies
Those who have received the required care certification
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kanai |
Organization
Toyohashi SOZO University Graduate School
Division name
Graduate School of Health Sciences
Zip code
440-8511
Address
20-1,Matsusita Ushikawa-cho,Toyohashi,Aichi
TEL
05020172276
kanai@sozo.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Nakajima |
Organization
Toyohashi SOZO University Graduate School
Division name
Graduate School of Health Sciences
Zip code
440-8511
Address
20-1,Matsusita Ushikawa-cho,Toyohashi,Aichi
TEL
05020172273
Homepage URL
ri-nakajima@sozo.ac.jp
Sponsor or person
Institute
Toyohashi SOZO University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Toyohashi SOZO University Graduate School
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
Toyohashi SOZO University IRB
Address
20-1,Matsusita Ushikawa-cho,Toyohashi,Aichi
Tel
0532542111
kanai@sozo.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
| 2019 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
A 12-week written cognitive task (homework) for mild cognitive impairment was conducted for healthy community-dwelling elderly who participated in a voluntary group in the city.Evaluation of cognitive, living and physical functions was performed before and after the intervention.
At the post-intervention evaluation, there was no change in living and physical functions, but the cognitive function (MoCA-J score and rate of change in executive function) showed a tendency to differ from the control group.
Results date posted
| 2020 | Year | 03 | Month | 30 | 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
| 2018 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 29 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041407
