UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036313
Receipt number R000041355
Scientific Title Elucidating the impact of daily activities on cognition and mental function
Date of disclosure of the study information 2019/03/27
Last modified on 2022/09/28 11:45:44

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Basic information

Public title

Elucidating the impact of daily activities on cognition and mental function

Acronym

Elucidating the impact of daily activities on cognition and mental function

Scientific Title

Elucidating the impact of daily activities on cognition and mental function

Scientific Title:Acronym

Elucidating the impact of daily activities on cognition and mental function

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the relationship between daily activities and cognitive and mental functions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Stroop task
Profile of Mood States 2nd Edition
The Two-Dimensional Mood Scale

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Daily activity task

Interventions/Control_2

Exercise task

Interventions/Control_3

Control task

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

right-handed elderly people

Key exclusion criteria

Physically and mentally handicapped person who can not perform tasks.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Tsuchiya

Organization

Nagano university of health and medicine

Division name

Faculty of Health Sciences

Zip code

3812227

Address

11-1 Imaihara-kawanakajima, Nagano, Nagano, Japan

TEL

0262140419

Email

tsuchiya.kenji@shitoku.ac.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Tsuchiya

Organization

Nagano university of health and medicine

Division name

Faculty of Health Sciences

Zip code

3812227

Address

11-1 Imaihara-kawanakajima, Nagano, Nagano, Japan

TEL

0262140419

Homepage URL


Email

tsuchiya.kenji@shitoku.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the promotion of science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nagano university of health and medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Gunma University

Address

3-39-15 Showa, Maebashi, Gunma, Japan

Tel

0275528740

Email

hitotaisho-ciru@ml.gunma-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

2019 Year 03 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Open public recruiting

Date of protocol fixation

2019 Year 03 Month 26 Day

Date of IRB

2019 Year 02 Month 04 Day

Anticipated trial start date

2019 Year 04 Month 09 Day

Last follow-up date

2024 Year 02 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 03 Month 27 Day

Last modified on

2022 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041355


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name