UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005280 |
|---|---|
| Receipt number | R000006277 |
| Scientific Title | prospective randomized controlled trial for cardiac rehabilitation program with innovative device |
| Date of disclosure of the study information | 2011/03/21 |
| Last modified on | 2011/04/14 18:38:40 |
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Basic information
Public title
prospective randomized controlled trial for cardiac rehabilitation program with innovative device
Acronym
trial for cardiac rehabilitation program with innovative device
Scientific Title
prospective randomized controlled trial for cardiac rehabilitation program with innovative device
Scientific Title:Acronym
trial for cardiac rehabilitation program with innovative device
Region
| Japan |
Condition
Condition
patients with pulmonary arterial hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of cardiac rehabilitation program for patients with pulmonary arterial hypertension by using Wii Fit® from Nintendo
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
exercise tolerability evaluated by cardiopulmonary exercise testing and 6 minutes walking test
Key secondary outcomes
evaluation of QOL, BNP and Uric Acid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
exercise therapy by using Wii Fit at home
Interventions/Control_2
no exercise therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient diagnosed as pulmonary arterial hypertension (Class 1 in Dana Point Classification), who are NYHA II or III.
Key exclusion criteria
1. Escalation of PH treatments within this 1 month.
2. Patient with acute right heart failure
3. Receiving home oxygen therapy
4. Patient who has already committing other exercise therapies
5. Patient with untreated congenital heart disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Tamura |
Organization
Keio University School of Medicine
Division name
Department of cardiology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Tamura |
Organization
Keio University School of Medicine
Division name
Department of cardiology
Zip code
Address
TEL
Homepage URL
u1@ta-mu.net
Sponsor or person
Institute
Department of cardiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of cardiology, Keio 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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 20 | Day |
Last modified on
| 2011 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006277
