UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046628 |
|---|---|
| Receipt number | 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 | 2025/01/25 14:32:53 |
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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 University of Medical Welfare
Division name
Department of Physical Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki city, Okayama
TEL
086-462-1111
ujikawa@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Ujikawa |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Physical Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki city, Okayama
TEL
086-462-1111
Homepage URL
ujikawa@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
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 University of Medical Welfare
Address
288, Matsushima, Kurashiki city, Okayama
Tel
086-462-1111
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
449
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 10 | Day |
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
| 2025 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053190
