UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045733 |
|---|---|
| Receipt number | R000052209 |
| Scientific Title | Effect of wearing a non-woven mask on the body during exercise |
| Date of disclosure of the study information | 2021/10/31 |
| Last modified on | 2024/04/17 14:35:48 |
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Basic information
Public title
Effect of wearing a non-woven mask on the body during exercise
Acronym
Effect of non-woven mask on the body during exercise
Scientific Title
Effect of wearing a non-woven mask on the body during exercise
Scientific Title:Acronym
Effect of non-woven mask on the body during exercise
Region
| Japan |
Condition
Condition
Healthy population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the effect of wearing a non-woven mask, which is said to be highly effective in protecting against infection, on the body during exercise.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure and heart rate before and after exercise
Key secondary outcomes
Body temperature before and after exercise
Blood pressure before and after exercise
Heart rate before and after exercise
Oxygen saturation before and after exercise
Perceived exercise intensity at the end of exercise
Changes in psychological scale before and after exercise
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise while wearing a non-woven mask
Interventions/Control_2
Exercise without wearing a non-woven mask
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who wish to participate in the research
Key exclusion criteria
People with serious cardiovascular disease that require significant restrictions on exercise
People with serious musculoskeletal disorders that require significant restrictions on exercise
Others who have other illnesses that require significant restrictions on exercise
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Ashikaga |
Organization
St. Marianna University School of Medicine
Division name
Sports Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa
TEL
0449778111
k2ashikaga@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Ashikaga |
Organization
St. Marianna University School of Medicine
Division name
Sports Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa
TEL
0449778111
Homepage URL
k2ashikaga@marianna-u.ac.jp
Sponsor or person
Institute
Department of Sports Medicine, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
St. Maryanna University School of Medicine Bioethics Committee
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-u.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 | 10 | 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
4
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 | 10 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | 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 | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052209
