UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044448
Receipt No. 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 2021/06/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email h0306@hp.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email 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 08 Month 01 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 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050776

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.