UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053419 |
|---|---|
| Receipt number | R000060957 |
| Scientific Title | Relationship between the type of audiovisual stimuli combined with bicycle ergometer and psychological and physiological indices |
| Date of disclosure of the study information | 2024/01/29 |
| Last modified on | 2024/01/23 18:59:32 |
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Basic information
Public title
Relationship between the type of audiovisual stimuli combined with bicycle ergometer and psychological and physiological indices
Acronym
Psychological and physiological effects of aerobic exercise with audiovisual stimulation
Scientific Title
Relationship between the type of audiovisual stimuli combined with bicycle ergometer and psychological and physiological indices
Scientific Title:Acronym
Psychological and physiological effects of aerobic exercise with audiovisual stimulation
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the psychological and physiological effects of bicycle ergometer exercise with audiovisual stimulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate
Subjective time
Key secondary outcomes
Oxygen intake
Autonomic activity
Subjective exercise intensity
Emotional response
Attention allocation
Sense of immersion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform aerobic exercise (bicycle ergometer) while listening to music
Interventions/Control_2
Perform aerobic exercise (bicycle ergometer) while watching the video
Interventions/Control_3
Perform aerobic exercise (bicycle ergometer) while playing video games
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Young healthy adults who usually listen to music, watch videos, and play video games
Key exclusion criteria
Persons with diseases of the lower limbs that interfere with the performance of the exercise task.
Those who have difficulty performing the exercise task conditions even after practicing.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Itokazu |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
324-8501
Address
2600-1 Kitakanemaru, Otawara City, Tochigi
TEL
0287-24-3000
itokazu@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Otake |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Odawara
Zip code
250-8588
Address
1-2-25 Shiroyama, Odawara City, Kanagawa
TEL
0465-21-6500
Homepage URL
s.ohtake@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
2600-1 Kitakanemaru, Otawara City, Tochigi
Tel
0287-24-3125
s-rinri@iuhw.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
| 2024 | Year | 01 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2024 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060957
