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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025806
Receipt No. R000029377
Scientific Title Longitudinal changes in physical activity before and after the administration of home oxygen therapy in the chronic respiratory failure patients
Date of disclosure of the study information 2017/02/01
Last modified on 2019/01/30

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Basic information
Public title Longitudinal changes in physical activity before and after the administration of home oxygen therapy in the chronic respiratory failure patients
Acronym Physical activity before and after the administration of home oxygen therapy
Scientific Title Longitudinal changes in physical activity before and after the administration of home oxygen therapy in the chronic respiratory failure patients
Scientific Title:Acronym Physical activity before and after the administration of home oxygen therapy
Region
Japan

Condition
Condition chronic respiratory failure patient
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the physical activity in the patients with chronic respiratort failure before and after administering home oxygen therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes physical activity before and after administerig home oxygen therapy
Key secondary outcomes prognosis after administering home oxygen therapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 long term oxygen therapy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient with diffuse lung disease who is going to take long term oxygen therapy.
Age over 20 years old, and those who can put physical activity monitor
Key exclusion criteria (1) the patients with acute respiratory failure
(2) the patient who is not able to put the monitor
(3) the patient for whom we judged inadequate to take this study
(4) the patinet who can not take informed consent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Nakayama
Organization Department of Medicine, Jichi Medical University
Division name Division of Pulmonary Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7350
Email mnakayama723@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Nakayama
Organization Department of Medicine, Jichi Medical University
Division name Division of Pulmonary Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7350
Homepage URL http://www.jichi.ac.jp/usr/kokyu/index.html
Email mnakayama723@jichi.ac.jp

Sponsor
Institute Department of Medicine, Jichi Medical University
Institute
Department

Funding Source
Organization Department of Medicine, Jichi Medical University
Organization
Division
Category of Funding Organization Other
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 自治医科大学病院

Other administrative information
Date of disclosure of the study information
2017 Year 02 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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 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
2017 Year 01 Month 23 Day
Last modified on
2019 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029377

Research Plan
Registered date File name
2019/01/30 臨床研究計画書(A17-変113) .doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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