UMIN-CTR Clinical Trial

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
Institute	Uekusa Gakuen University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049334