UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046330 |
|---|---|
| Receipt number | R000052866 |
| Scientific Title | Comparison of exercise induced hypoalgesia with supervised and non-supervised exercise in healthy subjects: pilot study |
| Date of disclosure of the study information | 2021/12/09 |
| Last modified on | 2021/12/09 09:41:14 |
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Basic information
Public title
Comparison of exercise induced hypoalgesia with supervised and non-supervised exercise in healthy subjects: pilot study
Acronym
The Effect of EIH with supervised exercise
Scientific Title
Comparison of exercise induced hypoalgesia with supervised and non-supervised exercise in healthy subjects: pilot study
Scientific Title:Acronym
The Effect of EIH with supervised exercise
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether supervised exercise is more effective in providing analgesia than non-supervised exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in pressure pain threshold before and after exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
supervised exercise
Interventions/Control_2
non-supervised exercise
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy college students
Key exclusion criteria
Exclusion criteria are those with neuromusculoskeletal disease, those who have taken analgesics or anti-inflammatory drugs in the past 7 days, and those who have not been advised by a physician to exercise.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Shiro |
Organization
Nagoya Gakuin University
Division name
Faculty of Rehabilitation Sciences
Zip code
456-0062
Address
3-1-17 Taiho Atsuta-ku Nagoya, 456-0062, Japan
TEL
052-678-4078
shiro823@ngu.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Shiro |
Organization
Nagoya Gakuin University
Division name
Faculty of Rehabilitation Sciences
Zip code
456-0062
Address
3-1-17 Taiho Atsuta-ku Nagoya, 456-0062, Japan
TEL
052-678-4078
Homepage URL
shiro823@ngu.ac.jp
Sponsor or person
Institute
Nagoya Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Nagoya Gakuin 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
Nagoya Gakuin University
Address
3-1-17 Taiho Atsuta-ku Nagoya, 456-0062, Japan
Tel
052-678-4089
uri@ngu.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 | 12 | Month | 09 | 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
20
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 | 10 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | 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 | 12 | Month | 09 | Day |
Last modified on
| 2021 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052866
| 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 |
