UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007847 |
|---|---|
| Receipt number | R000009248 |
| Scientific Title | The increase in daily activity improve exercise tolerance of patients with pulmonary arterial hypertension. |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2015/04/27 11:50:37 |
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Basic information
Public title
The increase in daily activity improve exercise tolerance of patients with pulmonary arterial hypertension.
Acronym
The cardiac rehabilitation for pulmonary arterial hypertension.
Scientific Title
The increase in daily activity improve exercise tolerance of patients with pulmonary arterial hypertension.
Scientific Title:Acronym
The cardiac rehabilitation for pulmonary arterial hypertension.
Region
| Japan |
Condition
Condition
pulmonary arterial hypertension
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I examine whether a pulmonary arterial hypertension patient's exercise tolerance improves by daily activity instruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
peak oxygen consumption, 6 minutes walk distance, shuttle walking test, and QOL assessment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
increase in the daily activity (MET * hour) for 12 weeks
Interventions/Control_2
control
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients with pulmonary arterial hypertension who can walk without any help.
Key exclusion criteria
The patients who can not walk.
Target sample size
20
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, Sizuoka
TEL
053-435-2385
irihiro-ham@umin.ac.jp
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, Sizuoka
TEL
053-435-2385
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
Department of clinical pharmacology & therapeutics, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
浜松医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 27 | Day |
Last modified on
| 2015 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009248
