UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059183 |
|---|---|
| Receipt number | R000067695 |
| Scientific Title | Acute effects of pursed lip breathing on dyspnea after 3 minutes step test in people with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2025/09/26 |
| Last modified on | 2025/09/25 13:33:16 |
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Basic information
Public title
Acute effects of pursed lip breathing on dyspnea after 3 minutes step test in people with chronic obstructive pulmonary disease
Acronym
Pursed lip breathing after Step test trial
Scientific Title
Acute effects of pursed lip breathing on dyspnea after 3 minutes step test in people with chronic obstructive pulmonary disease
Scientific Title:Acronym
Pursed lip breathing after Step test trial
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the acute effect of pursed lip breathing on dyspnea afterstep test in people with chronic obstructive pulmonary disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
dyspnea
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Pursed-lip breathing was performed for 3 minutes, beginning 1 minute before the step test, continuing during the test, and for 5 minutes after the test.
Interventions/Control_2
No pursed lip breathing
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Subjects with a confirmed diagnosis of chronic obstructive pulmonary disease
- Subjects with clinically stable disease
- Subjects aged 40 years or older
- Subjects who can provide informed consent to participate
Key exclusion criteria
- Subjects with comorbid conditions that make it difficult to climb stairs, such as musculoskeletal disorders or cognitive impairment.
- Subjects with comorbid conditions that may cause respiratory distress, such as severe heart failure or lung cancer.
- Subjects with an acute exacerbation within four weeks prior to the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Tanaka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy
Zip code
8528520
Address
1-7-1 sakamoto, Nagasaki, Japan
TEL
0958197919
tanakataka@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Tanaka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy
Zip code
8528520
Address
1-7-1 sakamoto, Nagasaki, Japan
TEL
0958197919
Homepage URL
tanakataka@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Department of Health Sciences Ethics Committee, Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 sakamoto, Nagasaki, Japan
Tel
0958197919
tanakataka@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
| 2025 | Year | 09 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067695
