UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042596
Receipt number 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 2021/04/17 07:42:11

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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 or person

Institute

Showa University

Institute

Department

Personal name



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

Value
https://center6.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