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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | chronic obstructive pulmonary disease | ||
Classification by specialty |
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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
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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 |
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Interventions/Control_1 | inspiratory muscle training with threthold breathing
50%PImax,30breath,2times/day,4weeks |
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Interventions/Control_2 | inspiratory muscle training with diaphramatic breathing
50%MVC,30breath,2times/day,4weeks |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | COPD
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |