UMIN-CTR Clinical Trial

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	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	Completed
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 03 Month 15 Day
Date analysis concluded	2021 Year 04 Month 29 Day

Other
Other related information

Management information
Registered date	2020 Year 11 Month 30 Day
Last modified on	2021 Year 04 Month 17 Day

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