UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055751 |
|---|---|
| Receipt number | R000063695 |
| Scientific Title | Effect of wearing a surgical mask on exercise-induced hypoxemia in patients with chronic respiratory disease undergoing long-term oxygen therapy |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2025/08/13 21:50:29 |
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Basic information
Public title
Effect of wearing a surgical mask on exercise-induced hypoxemia in patients with chronic respiratory disease undergoing long-term oxygen therapy
Acronym
Effect of wearing a surgical mask on exercise-induced hypoxemia in patients with chronic respiratory disease undergoing long-term oxygen therapy
Scientific Title
Effect of wearing a surgical mask on exercise-induced hypoxemia in patients with chronic respiratory disease undergoing long-term oxygen therapy
Scientific Title:Acronym
Effect of wearing a surgical mask on exercise-induced hypoxemia in patients with chronic respiratory disease undergoing long-term oxygen therapy
Region
| Japan |
Condition
Condition
chronic respiratory diseases
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify whether wearing a surgical mask reduces exercise-induced hypoxaemia in patients with chronic respiratory diseases on long-term oxygen therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
SpO2 at isotime during incremental shuttle walking test (ISWT)
Key secondary outcomes
SpO2, pulse rate, respiratory rate, dyspnoea and lower limb fatigue before ISWT and after the end of ISWT (immediately and for 5 min after the end)
Recovery time from the end of ISWT to the pre-start values for SpO2, pulse rate and respiratory rate
Walking distance during ISWT (incremental shuttle walking distance:ISWD)
Surgical mask discomfort
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wearing a surgical mask during ISWT
Interventions/Control_2
Non-wearing of surgical masks during ISWT
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic respiratory disease undergoing inpatient or outpatient rehabilitation
1) Patients who have not been hospitalised within 4 weeks for an exacerbation of an underlying disease or co-morbidity of the cardiovascular organs
2) Patients on long-term oxygen therapy with nasal cannula
3) Patients who are able to walk unassisted or with a cane
Key exclusion criteria
1) Persons who are unable to perform exercise stress tests due to cardiovascular, motor or neurological diseases or cognitive impairment
2) Persons using a reservoir oxygen supply cannula (e.g. Oxymiser)
3) Persons who have a change in medication for respiratory disease during the study period (e.g. addition or change of inhaled medication)
4) Persons who have difficulty in measuring SpO2 due to peripheral circulatory failure
5) Persons with problems in decision-making capacity, e.g. diagnosed with dementia or severely impaired cognitive function (Mini-Mental State Examination <20 points)
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Shusuke |
| Middle name | |
| Last name | Toyama |
Organization
Tagami Hospital
Division name
Department of Rehabilitation Medicine
Zip code
851-0251
Address
2-14-15 Tagami, Nagasaki City, Nagasaki Prefecture
TEL
095-826-8186
hnsnore225@gmail.com
Public contact
Name of contact person
| 1st name | Shusuke |
| Middle name | |
| Last name | Toyama |
Organization
Tagami Hospital
Division name
Department of Rehabilitation Medicine
Zip code
851-0251
Address
2-14-15 Tagami, Nagasaki City, Nagasaki Prefecture
TEL
095-826-8186
Homepage URL
hnsnore225@gmail.com
Sponsor or person
Institute
Others
Institute
Department
Personal name
Shusuke Toyama
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Masaki Respiratory Medicine Clinic, Nagasaki Pulmonary Rehabilitation Clinic, Kirigaoka Tsuda Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Health Sciences, Nagasaki University School of Medical and Dental Sciences
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
095-819-7198
gakujutu_gakuji@ml.nagasaki-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
| 2024 | Year | 10 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063695
