UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025484
Receipt number R000028956
Scientific Title Verification of the effect to prevent dementia of dual-task and N-back task by recreation
Date of disclosure of the study information 2016/12/31
Last modified on 2017/07/04 09:58:23

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Basic information

Public title

Verification of the effect to prevent dementia of dual-task and N-back task by recreation

Acronym

Validation of Dual-task and N-back task

Scientific Title

Verification of the effect to prevent dementia of dual-task and N-back task by recreation

Scientific Title:Acronym

Validation of Dual-task and N-back task

Region

Japan


Condition

Condition

Mild cognitive impairment

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Prophylactic intervention of dementia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement of cognitive function's score/3 months from start of intervention

Key secondary outcomes

Psychological well-being


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

Brain training using techniques of dual task and n back task.
Monthly intervention of one year, evaluation every six months.

Interventions/Control_2

Brain training using single task technique

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Those who can go on their own until the district public hall of the implementation location.

Key exclusion criteria

Those who can not go to the district public hall by themselves.

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazue Sawami

Organization

Nara Medical University

Division name

Faculty of Nursing

Zip code


Address

840 Shijo, Kashihara, Nara JAPAN

TEL

0744-22-3051

Email

sawami@naramed-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazue Sawami

Organization

Nara Medical University

Division name

Faculty of Nursing

Zip code


Address

840 Shijo, Kashihara, Nara JAPAN

TEL

0744-22-3051

Homepage URL


Email

sawami@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Nara Medical University

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor

Kashihara City Council of Social Welfare of Community Support Service Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

奈良県立医科大学(奈良県)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 31 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

1. Correlation between cognitive ability and stress (salivary alpha-amylase), cognitive ability and mental health (GHQ-12) were clarified.:Relationship between Mental Health/Stress Levels and Cognitive Function. Journal of Addiction Research.
2. The cognitive performance and body composition (muscle mass, etc.) are correlated, in particular showed a strong correlation with vascular age.:Relationship between cognitive function, vascular age and stress. International Journal of Case Studies in Clinical Research.

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

Main results already published

Date of protocol fixation

2015 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The course of research activities:
http://www.g-nursing.com/katsudou.php


Management information

Registered date

2016 Year 12 Month 31 Day

Last modified on

2017 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028956


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name