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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044396
Receipt No. 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 2021/06/01

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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
Email 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
Email onoku@tiger.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
Email 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
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
2021 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2022 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
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050715

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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