UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046451 |
|---|---|
| Receipt number | R000052631 |
| Scientific Title | Acute effects of manual breathing assist technique on lung volume and recruitment of accessory inspiratory muscle, reducing dyspnea in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2021/12/23 |
| Last modified on | 2022/06/24 10:19:30 |
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Basic information
Public title
Acute effects of manual breathing assist technique on lung volume and recruitment of accessory inspiratory muscle, reducing dyspnea in patients with chronic obstructive pulmonary disease
Acronym
Effects of manual breathing assist technique in patients with chronic obstructive pulmonary disease
Scientific Title
Acute effects of manual breathing assist technique on lung volume and recruitment of accessory inspiratory muscle, reducing dyspnea in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Acute effects of manual breathing assist technique on lung volume and recruitment of accessory inspiratory muscle, reducing dyspnea in patients with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the effects of MBAT on reducing dyspnea, changing lung volumes and recruitment of sternocleidomastoid (SCM) muscle in severe COPD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
lung volumes
Key secondary outcomes
muscle oxygenation
dyspnea
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
a manual breathing assist technique
Interventions/Control_2
a manual breathing assist technique
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
| 65 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
COPD diagnosis by a respiratory physician, and no acute exacerbation for more than two months.
Healthy people were screened during pre-participation to exclude those with pulmonary diagnosis and were further tested by spirometry to confirm absence of obstructive or restrictive impairments.
Key exclusion criteria
Exclusion criteria were: inability to lie in supine because of vertebral column or rib cage deformity or if they had osteoporosis with a history of compression and/or rib fractures.
Target sample size
28
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 Science
Zip code
852-8520
Address
1-7-1 Sakamotomachi, Nagasaki city, Nagasaki
TEL
+81958197919
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 Science
Zip code
852-8520
Address
1-7-1 Sakamotomachi, Nagasaki city, Nagasaki
TEL
+81958197919
Homepage URL
tanakataka@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Physical Therapy Science,
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science KAKENHI
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
Department of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 Sakamotomachi, Nagasaki city, Nagasaki
Tel
+81958197919
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
| 2021 | Year | 12 | Month | 23 | 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
28
Results
After respiratory assistance, tidal volume and preliminary inspiratory volume increased, and preliminary expiratory volume decreased.
Results date posted
| 2022 | Year | 06 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
chronic obstructive pulmonary disease:
14
elderly people: 14
Participant flow
Adverse events
Outcome measures
pulmonary function test
dyspnea
oxygenation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052631
