UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029681
Receipt number R000033922
Scientific Title Acute effects of exercise on cognitive functions and mental health
Date of disclosure of the study information 2017/10/24
Last modified on 2019/03/20 16:25:55

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Basic information

Public title

Acute effects of exercise on cognitive functions and mental health

Acronym

Acute effects of exercise

Scientific Title

Acute effects of exercise on cognitive functions and mental health

Scientific Title:Acronym

Acute effects of exercise

Region

Japan


Condition

Condition

Healthy Japanese

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate acute effects of exercise on cognitive functions and mental health

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive function(stroop, JART, D-CAT,memory updating, digit symbol coding)

Mental health(STAI, WHO-5, GHQ12: General Health Questionnaire 12, POMS, CES-D)

Key secondary outcomes

grip, 30-second stand and sit


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

combination training (single shot 30 minutes excise)

Interventions/Control_2

waiting (30 minutes waiting with reading book)

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

40 years-old <=

Age-upper limit

80 years-old >

Gender

Female

Key inclusion criteria

Healthy Japanese adults (age from 18 to 80)

Key exclusion criteria

We will exclude the subjects with mental disorder, diabetes, cranial nerve disease, cardiac disease, and high blood pressure. The subject have a limitation of exercise.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuta Kawashima

Organization

IDAC, Tohoku univeristy

Division name

Advanced brain image

Zip code


Address

Sendai, seiryo-machi 4-1

TEL

022-717-7988

Email

fbi@idac.tohoku.ac.j


Public contact

Name of contact person

1st name
Middle name
Last name Rui Nouchi

Organization

Tohoku Univeristy

Division name

Smart aging research center

Zip code


Address

Sendai, Seiryo-machi4-1

TEL

022-717-7988

Homepage URL


Email

rui.nouchi.a4@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Curves Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 24 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

2017 Year 10 Month 24 Day

Date of IRB

2017 Year 11 Month 27 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2022 Year 11 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

2017 Year 10 Month 24 Day

Last modified on

2019 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033922


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name