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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013295
Receipt No. R000015503
Scientific Title Walk distance in the time by the difference in oxygen cylinder transportation method, study on difference in menstruation index
Date of disclosure of the study information 2014/03/01
Last modified on 2014/02/27

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Basic information
Public title Walk distance in the time by the difference in oxygen cylinder transportation method, study on difference in menstruation index
Acronym Walk distance in the time by the difference in oxygen cylinder transportation method, study on difference in menstruation index
Scientific Title Walk distance in the time by the difference in oxygen cylinder transportation method, study on difference in menstruation index
Scientific Title:Acronym Walk distance in the time by the difference in oxygen cylinder transportation method, study on difference in menstruation index
Region
Japan

Condition
Condition Chronic respiratory failure patient
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For a chronic respiratory failure patient of the HOT use, I carry out a walk of the constant time using a different oxygen transportation method and evaluate the change of the menstruation index to be seen after a walk before a walk, the satisfaction of the patient, the importance of the disease, and examine an oxygen transportation method suitable for a patient. Furthermore, I consider whether it is related to disease severity and the transportation method of the disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Six minutes walk test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Cart use of two types
Interventions/Control_2 Cart use of the four-wheeled type
Interventions/Control_3 Cart use of the side-by-side travel type
Interventions/Control_4 Rucksack type use
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 A chronic respiratory failure patient during during Kitano Hospital, the hospital hospitalization attached to the Kinki University medical department or foreign going to hospital.
Key exclusion criteria The acute exacerbation period of the chronic respiratory failure.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Honda Noritsugu
Organization Kitano Hospital
Division name Rehabilitation center
Zip code
Address 2-4-20, Ogimachi, Kita-ku, Osaka-shi, Osaka
TEL 06-6312-1221
Email norihonda2002@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Honda Noritsugu
Organization Kitano Hospital
Division name Rehabilitation center
Zip code
Address 2-4-20, Ogimachi, Kita-ku, Osaka-shi, Osaka
TEL 06-6312-1221
Homepage URL
Email norihonda2002@yahoo.co.jp

Sponsor
Institute Rehabilitation centerin Kitano Hospital
Institute
Department

Funding Source
Organization Kitano Hospital
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2014 Year 03 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 Preinitiation
Date of protocol fixation
2014 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 02 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
2014 Year 02 Month 27 Day
Last modified on
2014 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015503

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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