UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017805 |
|---|---|
| Receipt number | R000020632 |
| Scientific Title | Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction |
| Date of disclosure of the study information | 2015/06/04 |
| Last modified on | 2019/12/10 19:52:26 |
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Basic information
Public title
Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction
Acronym
Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction
Scientific Title
Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction
Scientific Title:Acronym
Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction
Region
| Japan |
Condition
Condition
Elderly people with mild cognitive impairment
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make clear the effects of the addition of social interaction into exercise-based Dementia Prevention Class
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Montreal Cognitive Assessment(MoCA-J) will be evaluated at time of intervention as well as three months after commencement of intervention, and one year after commencement of intervention
Key secondary outcomes
Physical function, the TMIG Index of Competence, a 15-item Geriatric Depression Scale, SF-8 health survey, the japanese version of the abbreviated Lubben Social Network Scale and so on will be evaluated at time of intervention as well as three months after commencement of intervention, and nine months after commencement of intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Aerobic, dual-task, and group work once a week for a period of three months, 12 sessions total
Interventions/Control_2
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
Elderly people with mild cognitive impairment as well as those without
Key exclusion criteria
People who have already been diagnosed with dementia, people living with assistance
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | SHIBA |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
TEL
042-778-9693
y-shiba@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | SHIBA |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
TEL
042-778-9693
Homepage URL
y-shiba@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Allied Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Sasakawa Sports Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Allied Health Sciences institutional review board
Address
Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
Tel
042-778-9616
matsumi@kitasato-u.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
| 2015 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
https://obirin.repo.nii.ac.jp/?action=repository_uri&item_id=1973&file_id=22&file_no=1
Publication of results
Published
Result
URL related to results and publications
https://obirin.repo.nii.ac.jp/?action=repository_uri&item_id=1973&file_id=22&file_no=1
Number of participants that the trial has enrolled
33
Results
There were no significant differences during the three phases of measurement in cognitive function, social network, and quality of
life. While in physical function, TUG was
significantly lower at post evaluation than follow up evaluation, and walking steps were significantly higher at post evaluation
than pre evaluation.
Results date posted
| 2019 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elderly people (n=167), excepting individuals who received a diagnosis of dementia and
impaired activities of daily living
Participant flow
They screened using the Touch Panel- type
Dementia Assessment Scale (TDAS).
The inclusion criterion for the programs was a TDAS score of 3 to 13. A total of 33
elderly participated in the study.
Adverse events
nothing
Outcome measures
physical function, MoCA-J, LSNS-6, SF-8
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020632
