UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025806 |
|---|---|
| Receipt number | 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 | 2020/08/22 12:07:29 |
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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
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
mnakayama723@jichi.ac.jp
Sponsor or person
Institute
Department of Medicine, Jichi Medical University
Institute
Department
Personal name
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
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
| 2012 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029377
