UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032173
Receipt number R000036707
Scientific Title Comparison between respiratory care and early mobilization on patients with pneumonia
Date of disclosure of the study information 2018/04/10
Last modified on 2018/04/10 06:57:08

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Basic information

Public title

Comparison between respiratory care and early mobilization on patients with pneumonia

Acronym

Comparison between respiratory care and early mobilization on patients with pneumonia

Scientific Title

Comparison between respiratory care and early mobilization on patients with pneumonia

Scientific Title:Acronym

Comparison between respiratory care and early mobilization on patients with pneumonia

Region

Japan


Condition

Condition

pneumonia

Classification by specialty

Pneumology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison between respiratory care and early mobilization on patients with pneumonia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

mortality rate, antibiotic administration period, readmission rate

Key secondary outcomes

physical function, respiratory function, swallowing function


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Subjects are treated with respiratory care

Interventions/Control_2

Subjects are treated with early mobilization

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Person who was hospitalized for diagnosis of pneumonia and who intervened in rehabilitation within 48 hours from admission

Key exclusion criteria

Person with severe complications other than pneumonia

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Sakai

Organization

Kio University

Division name

Division of Health Science, Graduate School of Health Science

Zip code


Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

TEL

0745-54-1601

Email

sakenaoki06@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Sakai

Organization

Kio University

Division name

Division of Health Science, Graduate School of Health Science

Zip code


Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

TEL

0745-54-1601

Homepage URL


Email

sakenaoki06@yahoo.co.jp


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Kio University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN


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

おかたに病院(奈良県)


Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 10 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

Enrolling by invitation

Date of protocol fixation

2018 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 03 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

2018 Year 04 Month 10 Day

Last modified on

2018 Year 04 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036707


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name