UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044396 |
|---|---|
| Receipt number | R000050715 |
| Scientific Title | The study of lower extremity muscle activity during underwater pedaling exercise |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2024/12/06 09:51:18 |
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Basic information
Public title
The study of lower extremity muscle activity during underwater pedaling exercise
Acronym
The study of lower extremity muscle activity during underwater pedaling exercise
Scientific Title
The study of lower extremity muscle activity during underwater pedaling exercise
Scientific Title:Acronym
The study of lower extremity muscle activity during underwater pedaling exercise
Region
| Japan |
Condition
Condition
Healthy young adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare of lower extremity muscle activity during underwater pedaling exercise and walking by exercise intensity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximal voluntary contraction (MVC: gluteus medius, rectus femoris, biceps femoris, tibialis anterior, and gastrocnemius)
%MVC (gluteus medius, rectus femoris, biceps femoris, tibialis anterior, and gastrocnemius)
Key secondary outcomes
Body composition
Heart rate
Blood pressure
Rating of Perceived Exertion (RPE)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
1) Lower extremity muscle activity during pedaling exercise on land
2) Lower extremity muscle activity during underwater pedaling exercise
3) Lower extremity muscle activity during underwater treadmill walking
Interventions/Control_2
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 young adults who have given written informed consent
Key exclusion criteria
Those who have been diagnosed with cardiovascular disease in a physical examination, those who exercise difficulty in this study with musculoskeletal disease in the lower extremity or trunk, those who have allergic reactions to applied materials, and those who have a Body Mass Index of 25 or higher.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe-shi, Hyogo
TEL
0787964582
onoku@tiger.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe-shi, Hyogo
TEL
0787964582
Homepage URL
onoku@tiger.kobe-u.ac.jp
Sponsor or person
Institute
Kobe 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 University Graduate School of Health Sciences, Health Sciences Ethical Committee
Address
7-10-2 Tomogaoka, Suma, Kobe-shi, Hyogo
Tel
0787964502
syomu2@ams.kobe-u.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 | 06 | 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
5
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
| 2021 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 07 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050715
