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

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 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


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

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


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