UMIN-CTR Clinical Trial

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	2023 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	2021 Year 05 Month 31 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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