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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042891
Receipt No. R000048959
Scientific Title The effect of aerobic exercise on interoception and cognitive function in healthy university students
Date of disclosure of the study information 2021/01/04
Last modified on 2021/01/04

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Basic information
Public title The effect of aerobic exercise on interoception and cognitive function in healthy university students: a non-randomized controlled trial
Acronym The effect of aerobic exercise on interoception and cognitive function in healthy university students: a non-randomized controlled trial
Scientific Title The effect of aerobic exercise on interoception and cognitive function in healthy university students
Scientific Title:Acronym The effect of aerobic exercise on interoception and cognitive function in healthy university students
Region
Japan

Condition
Condition healthy university students
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we aimed to identify the changes in interoception induced by exercising at a level expected to improve cognitive function in healthy university students.
Basic objectives2 Others
Basic objectives -Others There was a significant positive correlation between IA and PASAT scores at pre-intervention. But exercise did not lead to a significant increase in PASAT scores in comparison with the control group.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IA scores were improved at 2- and 3-month post-intervention only in the exercise group.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 The exercise group performed bench step exercises at an intensity of 50% heart rate reserve for 30 minutes a day, three times a week, for three months.
Interventions/Control_2 Control group was directed not to make an extra habit of exercising in their leisure time during the study.
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
23 years-old >=
Gender Male and Female
Key inclusion criteria University students who have undergone a medical examination and are judged to be healthy.
Key exclusion criteria 1:Students athletes and University students who exercise frequency .

2:University students who have received a medical diagnosis of some kind of disability.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name Yusaku
Middle name
Last name Amaya
Organization Shijonawate Gakuen University
Division name Faculty of Rehabilitation
Zip code 5740011
Address Daitou-city Osaka Japan
TEL 072-863-5043
Email y-amaya@reha.shijonawate-gakuen.ac.jp

Public contact
Name of contact person
1st name Yusaku
Middle name
Last name Amaya
Organization Kansai Medical University
Division name Department of Psychosomatic and General Internal Medicine
Zip code 573-1010
Address 2-5-1 Shinmachi Hirakata city Osaka Japan
TEL 072-804-0101
Homepage URL
Email y-amaya@reha.shijonawate-gakuen.ac.jp

Sponsor
Institute Kansai Medical University
Department of Psychosomatic and General Internal Medicine
Institute
Department

Funding Source
Organization Kansai Medical University
Department of Psychosomatic and General Internal Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Psychosomatic and General Internal Medicine, Kansai Medical University
Address 2-5-1 Shinmachi Hirakata city Osaka Japan
Tel 072-804-0101
Email y-amaya@reha.shijonawate-gakuen.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
2021 Year 01 Month 04 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 44
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 Completed
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
2018 Year 06 Month 15 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2021 Year 03 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
2021 Year 01 Month 04 Day
Last modified on
2021 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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