UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041451 |
|---|---|
| Receipt number | R000047299 |
| Scientific Title | Effects of mask wearing on exercise tolerance and dyspnea in patients with chronic respiratory diseases |
| Date of disclosure of the study information | 2020/08/24 |
| Last modified on | 2021/02/17 23:15:46 |
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Basic information
Public title
Effects of mask wearing on exercise tolerance and dyspnea in patients with chronic respiratory diseases
Acronym
Mask study
Scientific Title
Effects of mask wearing on exercise tolerance and dyspnea in patients with chronic respiratory diseases
Scientific Title:Acronym
Mask study
Region
| Japan |
Condition
Condition
Chronic Occlusive Pulmonary Disease
Interstitial Lung Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the difference in dyspnea and exercise tolerance in patients with chronic respiratory diseases when they wear a mask.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walk distance
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
More than 30% and less than 80% of %FEV1
Key exclusion criteria
Less than 29% of %FEV1
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | KEISUKE |
| Middle name | |
| Last name | MORIKAWA |
Organization
Matsusaka municipal hospital
Division name
rehabilitation
Zip code
5158544
Address
1550 Tonomachi, Matsusaka City
TEL
0598231515
morikawagacha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | KEISUKE |
| Middle name | |
| Last name | MORIKAWA |
Organization
Matsusaka municipal hospital
Division name
rehabilitation
Zip code
5158544
Address
1550 Tonomachi, Matsusaka City
TEL
0598231515
Homepage URL
morikawagacha@yahoo.co.jp
Sponsor or person
Institute
Matsusaka municipal hospital
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
Matsusaka Municipal Hospital
Address
1550 Tonomachi, Matsusaka City
Tel
0598231515
morikawagacha@yahoo.co.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 | 08 | Month | 24 | 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
16
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 | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 07 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 08 | Month | 18 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047299
