UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043120 |
|---|---|
| Receipt number | R000049227 |
| Scientific Title | The effects of high-intensity interval training on hypoalgesia, improvement of cognitive function and mood |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2023/01/28 09:10:59 |
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Basic information
Public title
The effects of high-intensity interval training on hypoalgesia, improvement of cognitive function and mood
Acronym
The effects of high-intensity interval training on hypoalgesia, improvement of cognitive function and mood
Scientific Title
The effects of high-intensity interval training on hypoalgesia, improvement of cognitive function and mood
Scientific Title:Acronym
The effects of high-intensity interval training on hypoalgesia, improvement of cognitive function and mood
Region
| Japan |
Condition
Condition
Healthy young volunteer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of high-intensity interval training on pain sensitivity, pain inhibitory system, cognitive function and mood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantitative sensory testing
Key secondary outcomes
Cognitive function
Mood
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sedentary(24 min) -> high-intensity interval training(24 min of 4 cycling intervals, with 4 min at 70% HRR and 2 min of rest in each cycle)
Interventions/Control_2
High-intensity interval training (24min) -> Sedentary(24min)
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
| 18 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy young volunteers
Key exclusion criteria
Those who have pain, those who have color blindness, or women during menstruation.
Target sample size
70
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 651-2180, 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 651-2180, 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 651-2180, 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
神戸学院大学（兵庫県）/Kobe Gakuin University (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | 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
| 2020 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049227
