UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005313 |
|---|---|
| Receipt number | R000006315 |
| Scientific Title | Development of electric assist cart for patients with respiratory failure |
| Date of disclosure of the study information | 2011/03/25 |
| Last modified on | 2011/05/05 13:44:05 |
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Basic information
Public title
Development of electric assist cart for patients with respiratory failure
Acronym
Development of electric assist cart for patients with respiratory failure
Scientific Title
Development of electric assist cart for patients with respiratory failure
Scientific Title:Acronym
Development of electric assist cart for patients with respiratory failure
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the effects of the use of the electric cart on cardiorespiratory responses and ratings of perceived exertion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen uptake (VO2), minute ventilation (VE), and respiratory rate (RR)
Key secondary outcomes
Perceived exertion at the offset of exercise (RPE)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The subjects climing up the hill with the steepness of 6º for 50m (5m up) without carrying anything
Interventions/Control_2
The subjects climing up the hill with the steepness of 6º for 50m (5m up) with carrying a portable oxygen tank (weight: 5.3kg)
Interventions/Control_3
The subjects climing up the hill with the steepness of 6º for 50m (5m up)with the aid of the electric cart
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy volunteers
Key exclusion criteria
without respiratory, cardiac or orthopedic diseases
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tamaki |
Organization
Gradudate school of medicine, kyoto university
Division name
Human health sciences
Zip code
Address
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507 Japan
TEL
075-751-3973
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Tamaki |
Organization
Gradudate school of medicine, Kyoto university
Division name
Human health sciences
Zip code
Address
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507 Japan
TEL
Homepage URL
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio University
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 | 25 | 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
| 2007 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | 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
| 2011 | Year | 03 | Month | 25 | Day |
Last modified on
| 2011 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006315
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
