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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010072
Receipt No. R000011793
Scientific Title Comparison of symptom-limited exercise tests between incremental and constant work rate protocols.
Date of disclosure of the study information 2013/02/18
Last modified on 2018/05/08

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Basic information
Public title Comparison of symptom-limited exercise tests between incremental and constant work rate protocols.
Acronym Comparison of symptom-limited exercise tests between incremental and constant work rate protocols.
Scientific Title Comparison of symptom-limited exercise tests between incremental and constant work rate protocols.
Scientific Title:Acronym Comparison of symptom-limited exercise tests between incremental and constant work rate protocols.
Region
Japan

Condition
Condition healthy human
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to compare the limiting factors of exercise tests between incremental and constant work rate protocol in healthy humans.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes ventiratory, cardiovascular, muscle oxygenation response
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 incremental protocol of cycling exercise test
Interventions/Control_2 constant work rate of cycling exercise test
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
18 years-old <=
Age-upper limit
26 years-old >
Gender Male
Key inclusion criteria healthy human
Key exclusion criteria cardiopulmonary disease
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Tabira
Organization Kio University
Division name Graduate of health science
Zip code
Address 4-2-2 Umaminaka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL 0745541601
Email k.tabira@kio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junshiro Yamamoto
Organization Kio University
Division name Graduate of health science
Zip code
Address 4-2-2 Umaminaka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL 0745541601
Homepage URL
Email j_yamamoto1046@yahoo.co.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio 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
Address
Tel
Email

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
2013 Year 02 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 18 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011793

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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