UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042781 |
|---|---|
| Receipt number | R000048834 |
| Scientific Title | The effect of aerobic exercise on interoception and cognitive function in healthy university students: a non-randomized controlled trial |
| Date of disclosure of the study information | 2021/07/07 |
| Last modified on | 2020/12/18 02:05:30 |
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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: a non-randomized controlled trial
Scientific Title:Acronym
The effect of aerobic exercise on interoception and cognitive function in healthy university students: a non-randomized controlled trial
Region
| Japan |
Condition
Condition
healthy university students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cognitive function and interoception of healthy university students were repeatedly measured once a month, up to a total of four times. The exercise group was assigned to do the 30-minute step exercise once a day, three times a week, during the 3-month intervention. The control group was directed to spend time as usual, without any interventions.
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 was assigned to do the 30-minute step exercise once a day, three times a week, during the 3-month intervention.
Interventions/Control_2
The control group was directed to spend time as usual, without any interventions.
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
1. University students who have undergone a medical examination and are judged to be healthy
Key exclusion criteria
1. Student athletes and University students who exercise frequently
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
Faculty of Rehabilitation Shijonawate Gakuen University
Division name
Physical Therapy
Zip code
574-0011
Address
2-5-1 Shinmachi Hirakata city Osaka Japan
TEL
072-863-5043
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
y-amaya@reha.shijonawate-gakuen.ac.jp
Sponsor or person
Institute
Department of Psychosomatic and General Internal Medicine, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Psychosomatic and General Internal Medicine, Kansai Medical University
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
Kansai Medical University
Address
2-5-1 Shinmachi Hirakata city Osaka Japan
Tel
072-804-0101
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 | 07 | Month | 07 | 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 | 07 | 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
| 2020 | Year | 12 | Month | 18 | Day |
Last modified on
| 2020 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048834
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
