UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045189 |
|---|---|
| Receipt number | R000051624 |
| Scientific Title | Effect of maximal abdominal bulging on respiratory function |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2021/08/18 16:47:11 |
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Basic information
Public title
Effect of maximal abdominal bulging on respiratory function
Acronym
Effect of maximal abdominal bulging on respiratory function
Scientific Title
Effect of maximal abdominal bulging on respiratory function
Scientific Title:Acronym
Effect of maximal abdominal bulging on respiratory function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Pneumology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effect of the "maximum abdominal ridge method", which exercises with maximum awareness of the amount of abdominal swelling as inspiratory muscle training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal bulge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Repeat maximum abdominal ridge movement
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
2. Healthy adults aged 20 to 29
Key exclusion criteria
Those who did not agree with this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tashiro |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation, Department of Occupational Therapy
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi, Hyogo
TEL
078-974-1551
tashiro@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Tashiro |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation, Department of Occupational Therapy
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi, Hyogo
TEL
078-974-1551
Homepage URL
tashiro@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kobe Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Occupational Therapy, Faculty of Rehabilitation, Kobe Gakuin University
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi, Hyogo
Tel
078-974-1551
tashiro@reha.kobegakuin.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 | 08 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 07 | 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 | 08 | Month | 18 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051624
| 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 |
