UMIN-CTR Clinical Trial

Public title

Relationship between viral load and cough in elderly patients with influenza.

Acronym

Relationship between viral load and cough in elderly patients with influenza.

Scientific Title

Relationship between viral load and cough reflex sensitivity in elderly patients with influenza infection

Scientific Title:Acronym

Relationship between viral load and cough reflex sensitivity in elderly patients with influenza infection

Region

Japan

Condition

influenza

Classification by specialty

Infectious disease	Geriatrics	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Influenza is a viral infection that should be emphasized in the elderly. This is particularly a problem for the elderly because many patients become severe with secondary bacterial pneumonia. The general clinical picture of influenza is as high as 38 to 40 degrees. However, as for cough symptoms in influenza patients, although there are previous studies in healthy adults, we have not conducted any studies in the elderly population so far. Not. Moreover, there is no report which investigated the amount of influenza viruses scattered with cough over time. Therefore, in this study, we investigate the amount of virus scattering due to influenza cough and changes over time in the cough reflex in elderly people.

Basic objectives2

Others

Basic objectives -Others

Change over time
Infection prevention

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Cough frequency

Key secondary outcomes

Virus count
Cough impulse

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Residents of elderly facilities who cooperate with research.
65 years old or older.

Key exclusion criteria

Unable to obtain consent for this research.
Problems with cognitive function such as dementia.
Using ventilators.
Severe dysphagia.
Having respiratory diseases such as asthma and cough asthma.
Those taking antitussives.
Unable to maintain a stable posture.
The doctor judged that participation in the research was difficult, such as severe flu symptoms.

Target sample size

100

Name of lead principal investigator

1st name	MASAHIRO
Middle name
Last name	KOZUKI

Organization

Tohoku University School of Medicine

Division name

Internal Medicine and Rehabilitation Science

Zip code

980-8574

Address

1-1 Seiryocho, Aoba-ku, Sendai

TEL

022-717-7353

Email

kohzukip@med.tohoku.ac.jp

Name of contact person

1st name	KENJI
Middle name
Last name	MURAKAMI

Organization

Tohoku University School of Medicine

Division name

Internal Medicine and Rehabilitation Science

Zip code

980-8574

Address

1-1 Seiryocho, Aoba-ku, Sendai

TEL

022-717-7353

Homepage URL

Email

k_murakami@seiyogakuin.ac.jp

Institute

Tohoku University School of Medicine.
Internal Medicine and Rehabilitation Science.

Institute

Department

Personal name

Organization

Sendai Medical Center Virus Research Center.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN

Co-sponsor

Sendai Medical Center Virus Research Center.

Name of secondary funder(s)

Organization

Tohoku University School of Medicine Ethics Review Committee

Address

1-2 Seiryocho, Aoba-ku, Sendai

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

仙台医療センター(宮城県)
　

Date of disclosure of the study information

2019

Year

09

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2019

Year

09

Month

25

Day

Date of IRB

Anticipated trial start date

2019

Year

10

Month

01

Day

Last follow-up date

2023

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design.
Longitudinal observational study.
This study investigates changes in cough reflexes,cough impulses,and coughre leased virus levels over time due to inf luenza infection.

Research subjects.
Cohort senior citizens who are deemed suitable for subjects in medical facilities.

Measurement item.
Cough reflex caused by citric acid inhalation.
Presence or absence of cough impulse.
Number of viruses in cough.
Functional Independence Measure.
Grip strength.

Registered date

2019

Year

09

Month

25

Day

Last modified on

2019

Year

09

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043401