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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038732
Receipt No. R000044158
Scientific Title Trunk muscle activities during aquatic recumbent ergometer exercise
Date of disclosure of the study information 2019/11/30
Last modified on 2019/11/29

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Basic information
Public title Trunk muscle activities during underwater pedaling
Acronym Muscle activities during underwater pedaling
Scientific Title Trunk muscle activities during aquatic recumbent ergometer exercise
Scientific Title:Acronym Muscle activities during aquatic recumbent ergometer exercise
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of trunk muscle activities during aquatic recumbent ergometer exercise
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes % Maximum Voluntary Contractions of rectus abdominis (RA) muscle and erector spinae (ES) muscle
Key secondary outcomes heart rate

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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 recumbent ergometer exercise on land for 5 minutes
Interventions/Control_2 aquatic recumbent ergometer exercise for 5 minutes
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
Key inclusion criteria healthy young males who have written informed consent
Key exclusion criteria females, those with motor disorder, those with history of cardiovascular disease, smokers, those under medication, those with latex allergy, those with <20% in body fat
Target sample size 20

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, Hyogo, JAPAN
TEL 078-796-4582
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, Hyogo, JAPAN
TEL 078-796-4582
Homepage URL
Email onoku@tiger.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
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 078-792-2555
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
2019 Year 11 Month 30 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 17
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
2019 Year 05 Month 28 Day
Date of IRB
2019 Year 08 Month 22 Day
Anticipated trial start date
2019 Year 08 Month 23 Day
Last follow-up date
2020 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
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044158

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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