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 |
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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
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
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
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
