UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043099 |
|---|---|
| Receipt number | R000049200 |
| Scientific Title | Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD |
| Date of disclosure of the study information | 2021/01/22 |
| Last modified on | 2023/01/24 10:26:25 |
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Basic information
Public title
Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD
Acronym
Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD
Scientific Title
Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD
Scientific Title:Acronym
Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of inspiratory muscle training on the diaphragm in patient with COPD .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diaphragmatic excursion
Key secondary outcomes
exercise capacity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Setting Inspiratory Muscle Training for more than 12weeks.
Interventions/Control_2
Do not do inspiratory muscle training
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The participants are clinically stable COPD who visited the Department of Rehabilitation Medicine at kindai University Hospital.
Key exclusion criteria
The exclusion criteria includ unstable medical conditions that cause or contribute to breathlessness (i.e. metabolic, cardiovascular, or other respiratory diseases) or any other disorders that interfere with exercise testing, such as neuromuscular diseases or musculoskeletal problems.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Shiraishi |
Organization
Kindai University Hospital
Division name
Department of Rehabilitation
Zip code
589-8511
Address
377-2 Onohigashi, Osakasayama-city
TEL
072-366-0221
masashi-shiraishi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Shiraishi |
Organization
Kindai University Hospital
Division name
Department of Rehabilitation
Zip code
589-8511
Address
377-2 Onohigashi, Osakasayama-city
TEL
072-366-0221
Homepage URL
masashi-shiraishi@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Kindai University Hospital
Address
377-2 Onohigashi, Osakasayama-city
Tel
072-366-0221
masashi-shiraishi@med.kindai.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 | 01 | Month | 22 | 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 | 03 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049200
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
