UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005477 |
|---|---|
| Receipt number | 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 11:30:37 |
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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
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
irihiro-ham@umin.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology & Therapeutics, Hamamatsu University School of Medicine
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006435
