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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040573
Receipt No. 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 2020/05/28

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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
Email 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
Email thsryu0425@gmail.com

Sponsor
Institute Nara Medical University
Institute
Department

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
Email 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

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
2021 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
2020 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041446

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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