UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052603 |
|---|---|
| Receipt number | R000060029 |
| Scientific Title | Investigating the effect of aerobic exercise combined with virtual reality on hypoalgesia in healthy participants |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2025/05/23 08:19:27 |
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Basic information
Public title
Investigating the effect of aerobic exercise combined with virtual reality on hypoalgesia in healthy participants
Acronym
The effect of aerobic exercise combined with virtual reality on hypoalgesi
Scientific Title
Investigating the effect of aerobic exercise combined with virtual reality on hypoalgesia in healthy participants
Scientific Title:Acronym
The effect of aerobic exercise combined with virtual reality on hypoalgesi
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of aerobic exercise combined with virtual reality on hypoalgesia in healthy participants
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain
Key secondary outcomes
Mood
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) 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
Virtual reality intervention
Ten minutes
Interventions/Control_2
Actual exercise (cycling)
Ten minutes
Interventions/Control_3
Actual exercise combined with virtual reality
Ten minutes
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy young adults
Key exclusion criteria
Acute or chronic pain condition, pregnancy, menstruation
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
TEL
078-974-1551
matsubar@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
TEL
078-974-1551
Homepage URL
matsubar@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin 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
Kobe Gakuin University
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
Tel
078-974-1551
ethic@reha.kobegakuin.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
| 2023 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060029
