UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056607 |
|---|---|
| Receipt number | R000064692 |
| Scientific Title | Prevention of eccentric contraction-induced muscle damage and examination of cardiorespiratory dynamics during eccentric contraction exercise |
| Date of disclosure of the study information | 2025/01/05 |
| Last modified on | 2025/07/11 15:22:16 |
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Basic information
Public title
Prevention of muscle damage and changes in cardiorespiratory dynamics through eccentric contraction exercise
Acronym
Prevention of muscle damage and changes in cardiorespiratory dynamics
Scientific Title
Prevention of eccentric contraction-induced muscle damage and examination of cardiorespiratory dynamics during eccentric contraction exercise
Scientific Title:Acronym
Prevention of muscle damage and changes in cardiorespiratory dynamics in eccentric contraction exercise
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the mechanism of protective effect of eccentric contraction-induced muscle damage and changes in cardio-respiratory dynamics during eccentric contraction exercise
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle pain before and after eccentric contraction
Key secondary outcomes
Vital signs during exercise.
Muscle strength and skeletal muscle blood flow before and after eccentric contraction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Preconditioning group
Interventions/Control_2
Eccentric contraction group
Interventions/Control_3
Eccentric contraction cycling group
Interventions/Control_4
Concentric contraction cycling group
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who volunteer to participate
Key exclusion criteria
Persons with musculoskeletal disease, persons with circulatory disease, persons with respiratory disease, persons with exercise habits
Analgesic medication
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keishi |
| Middle name | |
| Last name | Hayao |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398 SHimami-cho, Kita-ku, Niigata-city, Niigata
TEL
0252574309
keishi-hayao@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Hayao |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398 SHimami-cho, Kita-ku, Niigata-city, Niigata
TEL
0252574309
Homepage URL
keishi-hayao@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 SHimami-cho, Kita-ku, Niigata-city, Niigata
Tel
0252574309
keishi-hayao@nuhw.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
| 2025 | Year | 01 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064692
