UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000057499
Receipt number R000065698
Scientific Title Effect of aerobic exercise on mental fatigue
Date of disclosure of the study information 2025/04/03
Last modified on 2025/04/03 12:09:22

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Basic information

Public title

Effect of aerobic exercise on mental fatigue

Acronym

Effect of aerobic exercise on mental fatigue

Scientific Title

Effect of aerobic exercise on mental fatigue

Scientific Title:Acronym

Effect of aerobic exercise on mental fatigue

Region

Japan


Condition

Condition

A person experiencing mental fatigue

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of aerobic exercise on the recovery from mental fatigue

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Conduct the flicker test before and after the intervention

Key secondary outcomes

Measure EEG before and after the intervention


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Other

Interventions/Control_1

Perform 20 minutes of aerobic exercise using a recumbent bike

Interventions/Control_2

Perform 20 minutes of bed rest in a supine position

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

20 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adults in their 20s and 30s

Key exclusion criteria

Individuals with cerebrovascular disease
Individuals who have been diagnosed with a mental disorder
Individuals with musculoskeletal or cardiovascular diseases that limit aerobic exercise

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Tomomi
Middle name
Last name Nomura

Organization

Fukui Health Science University

Division name

Department of Rehabilitation Physical Therapy, Faculty of Health Science

Zip code

910-3190

Address

55-13-1 Egamicho, Fukui-shi, Fukui

TEL

0776-59-2201

Email

t-nomura@fukui-hsu.ac.jp


Public contact

Name of contact person

1st name Tomomi
Middle name
Last name Nomura

Organization

Fukui Health Science University

Division name

Department of Rehabilitation Physical Therapy, Faculty of Health Science

Zip code

910-3190

Address

55-13-1 Egamicho, Fukui-shi, Fukui

TEL

0776-59-2201

Homepage URL


Email

t-nomura@fukui-hsu.ac.jp


Sponsor or person

Institute

Fukui Health Science University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee of Nittazuka Medical Welfare Center

Address

58-16-1 Egamicho, Fukui-shi, Fukui

Tel

0776-59-1300

Email

fgh-hisyo@mopera.net


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

2025 Year 04 Month 03 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

2022 Year 10 Month 01 Day

Date of IRB

2022 Year 11 Month 28 Day

Anticipated trial start date

2022 Year 12 Month 01 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 04 Month 03 Day

Last modified on

2025 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065698