![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017805 |
Receipt No. | 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 |
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 |
|
Condition | |||
Condition | Elderly people with mild cognitive impairment | ||
Classification by specialty |
|
||
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 |
|
||
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
Institute | Kitasato University School of Allied Health Sciences |
Institute | |
Department |
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 |
|
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 |
|
||||||
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020632 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |