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
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
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
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
