UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030547
Receipt number R000034747
Scientific Title Multivariate analysis of coughing ability using functional evaluation for hospitalized patients.
Date of disclosure of the study information 2018/01/31
Last modified on 2018/06/26 22:07:01

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Basic information

Public title

Multivariate analysis of coughing ability using functional evaluation for hospitalized patients.

Acronym

Examination of sputum production ability using functional evaluation.

Scientific Title

Multivariate analysis of coughing ability using functional evaluation for hospitalized patients.

Scientific Title:Acronym

Examination of sputum production ability using functional evaluation.

Region

Japan


Condition

Condition

hospitalized patient

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We clarify the relationship between the respiratory function that the therapist can measure by hand or the like and the cough peak flow, it aims to find indicators that can easily grasp factors of coughing power even in clinical treatment.

Basic objectives2

Others

Basic objectives -Others

Causal relationship

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Cough peak flow
(Measured on the same day as key secondary outcomes)

Key secondary outcomes

Vital capacity, percent vital capacity, thorax extension difference, maximum phonation time, abdominal uplift force, trunk flexor muscle strength, age, height, body weight, body mass index,
Functional Independence Measure.
(Measurement and calculation on the same day as the primary outcomes)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Intervene once during discharging.
Cough peak flow is measured three times.

Vital capacity is measured twice.

Thorax extension difference is measured once.

maximum phonation time is measured twice.

abdominal uplift force is measured twice.

trunk flexor muscle strength is measured twice.

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

95 years-old >=

Gender

Male and Female

Key inclusion criteria

hospitalized patient.

Rehabilitation is prescribed.

Adequate understanding and consent are obtained for the evaluation and research objectives.

Sitting retention is monitored or independent.

Key exclusion criteria

Patients with poor subjective symptoms such as breathing difficulty and pain.

Patient who can not make effortive cough.

Patient who can not follow the indicated action due to consciousness disturbance, mental disorder, dementia, etc.

Tracheal intubation, tracheostomy patients or patients undergoing thoracoabdominal surgery.

A patient suffering from an infectious disease such as MRSA.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iwai Nobuhiko

Organization

KOBE GAKUIN UNIVERSITY

Division name

Faculty of Rehabilitation

Zip code


Address

Kobe City, Hyogo Prefecture, Nishi-ku, Ikawadani MachiArase 518

TEL

078-974-1551

Email

iwai@reha.kobegakuin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Iwai Nobuhiko

Organization

KOBE GAKUIN UNIVERSITY

Division name

Faculty of Rehabilitation

Zip code


Address

Kobe City, Hyogo Prefecture, Nishi-ku, Ikawadani MachiArase 518

TEL

078-974-1551

Homepage URL


Email

iwai@reha.kobegakuin.ac.jp


Sponsor or person

Institute

Social medical corporation,
Saneikai,Tsukazaki hospital.

Institute

Department

Personal name



Funding Source

Organization

KOBE GAKUIN 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



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 31 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

Terminated

Date of protocol fixation

2017 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 31 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 12 Month 24 Day

Last modified on

2018 Year 06 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034747


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name