UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044448 |
|---|---|
| Receipt number | R000050776 |
| Scientific Title | Time series analysis of myoelectric activity and thoracoabdominal movements during the Test of Incremental Respiratory Endurance (TIRE) |
| Date of disclosure of the study information | 2021/06/06 |
| Last modified on | 2021/12/06 11:30:38 |
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Basic information
Public title
Time series analysis of myoelectric activity and thoracoabdominal movements during the Test of Incremental Respiratory Endurance (TIRE)
Acronym
Time series analysis of myoelectric activity and thoracoabdominal movements during the Test of Incremental Respiratory Endurance (TIRE)
Scientific Title
Time series analysis of myoelectric activity and thoracoabdominal movements during the Test of Incremental Respiratory Endurance (TIRE)
Scientific Title:Acronym
Time series analysis of myoelectric activity and thoracoabdominal movements during the Test of Incremental Respiratory Endurance (TIRE)
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to kinematically analyze the activity of multiple respiratory muscles using a combination of 3D motion analysis and electromyography in order to identify factors that define respiratory muscle endurance. In this study, we will measure Optoelectronic plethysmography (OEP) and electromyography of respiratory assist muscles during TIRE in healthy adults and elderly people. To clarify the standard thoracoabdominal exercise and to identify the respiratory muscle activity required for it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained Maximal Inspiratory Pressure
Key secondary outcomes
Height, weight, age, % lung capacity, 1 sec rate, max inspiratory pressure
Myoelectric activity: sternocleidomastoid, trapezius, vastus lateralis, erector spinae, intercostal muscles, diaphragm, external oblique abdominal muscles, rectus abdominis
Chest and abdomen movement: Volume of upper rib cage, lower rib cage, and abdomen
Muscle mass: Diaphragm, intercostal muscles, rectus abdominis, oblique abdominis, transversus abdominis muscle thickness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform TIRE using respiratory muscle testing equipment. Observe thoracoabdominal movements and myoelectric activity using the VICON three-dimensional motion analysis system and surface electromyography during implementation.
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
| 21 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
Persons with normal respiratory function and independence in activities of daily living.
Key exclusion criteria
Those with severe mental or cognitive impairment. Those with serious pre-existing conditions (myocardial infarction or cerebral infarction), history of pneumothorax, large pulmonary cysts, or aortic aneurysm.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Sato |
Organization
Kawasaki Medical School
Division name
Rehabilitation Medicine
Zip code
7010192
Address
577 Matsushima, Kurashiki City, Okayama
TEL
0864621111
h0306@hp.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Sato |
Organization
Kawasaki Medical School
Division name
Rehabilitation Medicine
Zip code
7010192
Address
577 Matsushima, Kurashiki City, Okayama
TEL
0864621111
Homepage URL
h0306@hp.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577 Matsushima, Kurashiki City, Okayama
Tel
0864621111
h0306@hp.kawasaki-m.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 | 06 | Month | 06 | 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 | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | 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 | 06 | Month | 06 | Day |
Last modified on
| 2021 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050776
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| Registered date | File name |
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| Registered date | File name |
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