UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039432
Receipt number R000044954
Scientific Title Effect of diaphragmatic breathing during inspiratory muscle training on respiratory muscle activity
Date of disclosure of the study information 2020/02/10
Last modified on 2021/08/10 22:04:05

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Basic information

Public title

Effect of diaphragmatic breathing during inspiratory muscle training on respiratory muscle activity

Acronym

Effect of diaphragmatic breathing during inspiratory muscle training on respiratory muscle activity

Scientific Title

Effect of diaphragmatic breathing during inspiratory muscle training on respiratory muscle activity

Scientific Title:Acronym

Effect of diaphragmatic breathing during inspiratory muscle training on respiratory muscle activity

Region

Japan


Condition

Condition

Healthy young people

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of diaphragmatic breathing during inspiratory muscle training on activities of diaphragm and accessory respiratory muscle in healthy young people.

Basic objectives2

Others

Basic objectives -Others

To clarify the proper load on inspiratory muscle training.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle activity of accessory respiratory muscle using surface electromyogram,
diaphragm muscle thickness using an ultrasonic diagnostic imaging system

Key secondary outcomes

Chest Expansion
abdominal Expansion


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Medicine

Interventions/Control_1

Inspiratory muscle training under diaphragmatic breathing awareness

Interventions/Control_2

Inspiratory muscle training non specific breathing

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

18 years-old <=

Age-upper limit

40 years-old >

Gender

Male

Key inclusion criteria

Healthy young people

Key exclusion criteria

Pulmonery diseases,Cardiovascular disease,History of pneumothorax

Target sample size

30


Research contact person

Name of lead principal investigator

1st name shinya
Middle name
Last name ohta

Organization

Kio University

Division name

Division of Health Science, Graduate School of Health Science

Zip code

635-0832

Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

TEL

0745-54-1601

Email

s_oota1118@yahoo.co.jp


Public contact

Name of contact person

1st name shinya
Middle name
Last name ohta

Organization

Kio University

Division name

Division of Health Science, Graduate School of Health Science

Zip code

635-0832

Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

TEL

0745-54-1601

Homepage URL


Email

s_oota1118@yahoo.co.jp


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Kio University

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

Kio University

Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

Tel

0745-54-1602

Email

soumu@kio.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

大阪府済生会吹田病院(大阪)、畿央大学(奈良県)


Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 10 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

Completed

Date of protocol fixation

2020 Year 01 Month 25 Day

Date of IRB

2020 Year 05 Month 20 Day

Anticipated trial start date

2020 Year 02 Month 10 Day

Last follow-up date

2020 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

2020 Year 02 Month 07 Day

Last modified on

2021 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044954


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name