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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046628
Receipt No. R000053190
Scientific Title Age-specific reference values and prediction equations, sarcopenia cut-off value for Sustained Maximal Inspiratory Pressure
Date of disclosure of the study information 2022/01/13
Last modified on 2022/01/13

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Basic information
Public title Age-specific reference values and prediction equations, sarcopenia cut-off value for Sustained Maximal Inspiratory Pressure
Acronym Age-specific reference values and prediction equations, sarcopenia cut-off value for Sustained Maximal Inspiratory Pressure
Scientific Title Age-specific reference values and prediction equations, sarcopenia cut-off value for Sustained Maximal Inspiratory Pressure
Scientific Title:Acronym Age-specific reference values and prediction equations, sarcopenia cut-off value for Sustained Maximal Inspiratory Pressure
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to measure Sustained Maximal Inspiratory Pressure, an assessment of respiratory muscle function, to calculate chronological reference values and prediction equations, cutoff values for sarcopenia, and to extract related factors, thereby establishing a commonly used evaluation index.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sustained Maximal Inspiratory Pressure
Key secondary outcomes % lung capacity, 1 sec rate, max inspiratory pressure
Height, weight, age, sex, comorbidities, Smoking history
Global Physical Activity Questionnaire
Short Physical Performance Battery, Body composition, grip strength, 30-second chair stand test, respiratory 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 Measure SMIP using respiratory muscle testing equipment. Other assesment items is measured on the same day.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria adult
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 780

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Ujikawa
Organization Kawasaki Medical School Hospital
Division name Rehabilitation Center
Zip code 701-0192
Address 577, Matsushima, Kurashiki city, Okayama
TEL 086-462-1111
Email ujikawa@mw.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Ujikawa
Organization Kawasaki Medical School Hospital
Division name Rehabilitation Center
Zip code 701-0192
Address 577, Matsushima, Kurashiki city, Okayama
TEL 086-462-1111
Homepage URL
Email ujikawa@mw.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kawasaki Medical School Hospital
Address 577, Matsushima, Kurashiki city, Okayama
Tel 086-462-1111
Email ujikawa@mw.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
2022 Year 01 Month 13 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
2022 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2022 Year 04 Month 01 Day
Last follow-up date
2026 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 13 Day
Last modified on
2022 Year 01 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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