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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name