UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040573 |
|---|---|
| Receipt number | R000041446 |
| Scientific Title | The efficacy of inspiratory muscle training with diaphragmatic breathing in COPD |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2024/12/28 23:09:11 |
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Basic information
Public title
The efficacy of inspiratory muscle training with diaphragmatic breathing in COPD
Acronym
The efficacy of inspiratory muscle training with diaphragmatic breathing in COPD
Scientific Title
The efficacy of inspiratory muscle training with diaphragmatic breathing in COPD
Scientific Title:Acronym
The efficacy of inspiratory muscle training with diaphragmatic breathing in COPD
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Make the effectiveness of inspiratory muscle training with diaphramatic breathing in COPD clear.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maximal inspiratory pressure at 4 weeks after start of inspiratory muscle training
Key secondary outcomes
maximal expiratory pressure,muscle strength of diaphragm,vital capacity,inspiratory capacity,forced expiratory volume in 1st second,maximal voluntary ventilation,functional residual capacity,leam body mass index,COPD Assessment Test.
endurance time,dyspnea,leg discomfort,heart rate,respiratory rate,ventilattory equivalent,ventilatory equivalent for oxygen,ventilatory equivalent for carbon dioxide,the ratio of inspiratory to total time in exercise test.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
inspiratory muscle training with threthold breathing
50%PImax,30breath,2times/day,4weeks
Interventions/Control_2
inspiratory muscle training with diaphramatic breathing
50%MVC,30breath,2times/day,4weeks
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
COPD
Key exclusion criteria
difficulty in respiratory muscle training
80%PImax or more
cerebral infarction within 1 month
COPD acute exacerbation within 3 months
history of angina pectoris,myocardial infarction,pneumothorax
aortic aneurysm
giant bulla
Study participation is difficult by a spirit disease and a merger of the spirit symptom.
Resting systolic blood pressure of 180 mmHg or more, diastolic blood pressure of 100 mmHg or more
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Tsuji |
Organization
Pref Osaka Saiseikai Izuo Hospital
Division name
Rehabilitation center
Zip code
5510032
Address
3-4-5 Kitamura Taisho-ku,Osaka-shi
TEL
06-6552-0091
thsryu0425@gmail.com
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Tsuji |
Organization
Pref Osaka Saiseikai Izuo Hospital
Division name
Rehabilitation center
Zip code
5510032
Address
3-4-5 Kitamura Taisho-ku,Osaka-shi
TEL
06-6552-0091
Homepage URL
thsryu0425@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 Sijyoutyou kashihara-Shi,Nara-ken
Tel
0744-22-3051
ino_rinri@naramed-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
奈良県立医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 05 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041446
