UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043230
Receipt number R000049334
Scientific Title Analysis of the effect of wearing face masks on vital signs and dyspnea during exercise
Date of disclosure of the study information 2021/02/02
Last modified on 2022/03/30 18:10:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Analysis of the effect of wearing face masks on vital signs and dyspnea during exercise

Acronym

Analysis of the effect of wearing face masks on vital signs and dyspnea during exercise

Scientific Title

Analysis of the effect of wearing face masks on vital signs and dyspnea during exercise

Scientific Title:Acronym

Analysis of the effect of wearing face masks on vital signs and dyspnea during exercise

Region

Japan


Condition

Condition

Medicine in general, Surgery in general, Rehabilitation medicine, Healthy Adults

Classification by specialty

Medicine in general Surgery in general Rehabilitation medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of wearing face masks on vital signs and dyspnea during exercise in healthy subjects

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Dyspnea by numerical rating scale (NRS)

Key secondary outcomes

pulse rate, and peripheral oxygen saturation by pulse oximeter


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Wearing no mask (1 hour)

Interventions/Control_2

wearing a cloth mask (1 hour)

Interventions/Control_3

wearing a surgical mask (1 hour)

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

Key inclusion criteria

healthy male adults

Key exclusion criteria

Exclude those who have had a serious illness in the past, those who have fever, dry cough, malaise, sore throat, diarrhoea, conjunctivitis, headache, dullness of taste, dullness of smell, skin rash, discolouration of fingers or toes, shortness of breath, chest pain, and those who may have come into contact with COVID-19 infected persons during the interview on the day of measurement.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Isato
Middle name
Last name Fukushi

Organization

Uekusa Gakuen University

Division name

Faculty of Health Sciences

Zip code

2640007

Address

1639-3 Ogura-cho, Wakaba-ku, Chiba

TEL

0432392671

Email

i-fukushi@uekusa.ac.jp


Public contact

Name of contact person

1st name Isato
Middle name
Last name Fukushi

Organization

Uekusa Gakuen University

Division name

Faculty of Health Sciences

Zip code

2640007

Address

1639-3 Ogura-cho, Wakaba-ku, Chiba

TEL

0432392671

Homepage URL


Email

i-fukushi@uekusa.ac.jp


Sponsor or person

Institute

Uekusa Gakuen University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Uekusa Gakuen University Research Ethics Committee

Address

1639-3 Ogura-cho, Wakaba-ku, Chiba

Tel

0432392672

Email

m-yamamoto@uekusa.ac.jp


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

2021 Year 02 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258104

Number of participants that the trial has enrolled

24

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

Completed

Date of protocol fixation

2021 Year 02 Month 02 Day

Date of IRB

2020 Year 10 Month 02 Day

Anticipated trial start date

2021 Year 02 Month 02 Day

Last follow-up date

2022 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 02 Month 02 Day

Last modified on

2022 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049334


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name