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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name