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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005477
Receipt No. R000006435
Scientific Title The comparison of shuttle walking test with 6 minutes walking test for assessment of cardiopulmonary function of pulmonary hypertension
Date of disclosure of the study information 2011/05/01
Last modified on 2013/04/22

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Basic information
Public title The comparison of shuttle walking test with 6 minutes walking test for assessment of cardiopulmonary function of pulmonary hypertension
Acronym The comparison of SWT with 6MWT for pulmonary hypertension
Scientific Title The comparison of shuttle walking test with 6 minutes walking test for assessment of cardiopulmonary function of pulmonary hypertension
Scientific Title:Acronym The comparison of SWT with 6MWT for pulmonary hypertension
Region
Japan

Condition
Condition pulmonary hypertension
Classification by specialty
Medicine in general Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare 6 minutes walking test with shuttle walking test for assess cardiopulmonary function of pulmonary hypertension.
Basic objectives2 Others
Basic objectives -Others To assess the correlation between maximal oxygen uptake and the distance of 6MWT and SWT.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes maximal oxygen uptake, the distance of 6 minutes walking test, the distance of shuttle walking test,muscle strength of lower extremity
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria pulmonary hypertension
WHO grade 1 or 2
Key exclusion criteria unable to walk
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Watanabe
Organization Hamamatsu University School of Medicine
Division name Department of Clinical Pharmacology & Therapeutics
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL 053-475-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Irisawa
Organization Hamamatsu University School of Medicine
Division name Department of Clinical Pharmacology & Therapeutics
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL 053-435-2111
Homepage URL
Email irihiro-ham@umin.ac.jp

Sponsor
Institute Department of Clinical Pharmacology & Therapeutics, Hamamatsu University School of Medicine
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
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 浜松医科大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2011 Year 05 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 Completed
Date of protocol fixation
2011 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2012 Year 12 Month 31 Day
Date analysis concluded
2013 Year 04 Month 01 Day

Other
Other related information The relationship between maximal oxygen uptake, the distance of 6 minutes walk test, and shuttle walking test.

Management information
Registered date
2011 Year 04 Month 21 Day
Last modified on
2013 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006435

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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