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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042596
Receipt No. R000048614
Scientific Title Investigation of the effects on 6-minute walking with a surgical mask in patients with chronic obstructive pulmonary disease
Date of disclosure of the study information 2020/11/30
Last modified on 2020/11/30

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Basic information
Public title Investigation of the effects on 6-minute walking with a surgical mask in patients with chronic obstructive pulmonary disease
Acronym Investigation of the Effects of Surgical Masks in Patients with COPD
Scientific Title Investigation of the effects on 6-minute walking with a surgical mask in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym Investigation of the Effects of Surgical Masks in Patients with COPD
Region
Japan

Condition
Condition Chronic Obstructive Pulmonary Disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examining the effects of wearing a surgical mask on patients with COPD
Basic objectives2 Others
Basic objectives -Others Effect of surgical mask on patients with COPD
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences in 6-minute walking distance between subjects with and without a surgical mask
Key secondary outcomes Comparison of resting SPO2 values with and without a surgical mask
Comparison of lowest SPO2 values during exertion with and without a surgical mask
Comparison of max HR values with and without a surgical mask
Distance and time to achieve SPO2 < 90% with and without a surgical mask
Comparison of the Borg Scale during 6-minute Walking with and without a Surgical Mask
Clinical characteristics of patients with or without a 6-minute walk distance greater than Minimal Clinically Important Difference (MCID) with or without a surgical mask
Clinical characteristics of patients with and without a surgical mask whose Borg scale was larger than or equal to MCID
Clinical characteristics of patients with and without a surgical mask whose SPO2 fell below 90%

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 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Patients who first wear a surgical mask for a 6-minute walk test and then do a 6-minute walk test without a surgical mask.
Interventions/Control_2 Patients who first undergo a 6-minute walk test without a surgical mask and then undergo a 6-minute walk test with a surgical 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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria COPD patients aged 40 years or older attending Showa University Hospital
Key exclusion criteria 1) Patients who have difficulty walking for 6 minutes due to neurological or orthopedic disorders
2) Patients who are contraindicated in the 6-minute walking test (Unstable angina within 1 month, myocardial infarction, stable angina, resting HR is 120/min or more, systolic blood pressure is 180mmHg or more, or diastolic blood pressure is 100mmHg or more)
3) Patients who have been diagnosed with heart failure and are being treated for heart failure
4) Patients who are judged to be ineligible at the discretion of the investigator
Target sample size 42

Research contact person
Name of lead principal investigator
1st name Kuniaki
Middle name
Last name Hirai
Organization Showa University
Division name Department of Medicine, Division of Respiratory Medicine and Allergology
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email hiraik@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Kuniaki
Middle name
Last name Hirai
Organization Showa University
Division name Department of Medicine, Division of Respiratory Medicine and Allergology
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Homepage URL
Email hiraik@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

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 Showa University
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel 03-3784-8129
Email m-rinri@ofc.showa-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
2020 Year 11 Month 30 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
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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 05 Day
Date of IRB
2020 Year 10 Month 05 Day
Anticipated trial start date
2020 Year 11 Month 30 Day
Last follow-up date
2021 Year 02 Month 27 Day
Date of closure to data entry
2021 Year 02 Month 27 Day
Date trial data considered complete
2021 Year 02 Month 27 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 11 Month 30 Day
Last modified on
2020 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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