UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054054 |
|---|---|
| Receipt number | R000061715 |
| Scientific Title | Effect of trunk position on muscle activity and fatigue during cycling |
| Date of disclosure of the study information | 2024/04/04 |
| Last modified on | 2024/04/03 18:00:23 |
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Basic information
Public title
Effect of trunk lean angle on muscle activity and fatigue during cycling
Acronym
Trunk lean during cycling and muscle activity and fatigue
Scientific Title
Effect of trunk position on muscle activity and fatigue during cycling
Scientific Title:Acronym
Trunk position during cycling and muscle activity and fatigue
Region
| Japan |
Condition
Condition
Healthy males
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of trunk flexion position and draw-in maneuver on muscle activity and fatigue during cycling on competitive bike compared to those during cycling common bike.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity and fatigue
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
cycling at 10 degree of trunk flexion
Interventions/Control_2
cycling at 30 degree of trunk flexion
Interventions/Control_3
cycling at 60 degree of trunk flexion
Interventions/Control_4
cycling at 60 degree of trunk flexion with draw-in maneuver
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males
Key exclusion criteria
1)History of surgery
2)Persons who have pain during cycling by orthopedic or medical disease
3)smokers
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Okubo |
Organization
Saitama Medical University
Division name
Faculty of Medical and Health Care
Zip code
3500496
Address
981, Kawakado, Moroyama-machi, Saitama
TEL
0492951001
yokubo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Okubo |
Organization
Saitama Medical University
Division name
Faculty of Medical and Health Care
Zip code
357-0031
Address
981, Kawakado, Moroyama-machi, Saitama
TEL
0492951001
Homepage URL
yokubo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical 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
Reseach Administration Center, Saitama Medical University
Address
38, Hongo, Moroyamamachi, Saitama
Tel
049-276-2143
rinri@saitama-med.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 | 04 | Month | 04 | 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
| 2024 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2026 | 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 | 04 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061715
| 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 |
