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 2024/01/19 11:40:17

* 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

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

Email

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


Email

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

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

Partially published


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

Open public 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

2024 Year 01 Month 19 Day



Link to view the page

Value
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