UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039260
Receipt number R000044772
Scientific Title Effects of respiratory muscle stretch gymnastics in term of respratory function, chest wall expansion, and respiratory muscle strength in healthy subjects.
Date of disclosure of the study information 2020/01/27
Last modified on 2021/01/26 10:30:02

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Basic information

Public title

Effects of respiratory muscle stretch gymnastics in term of respratory function, chest wall expansion, and respiratory muscle strength in healthy subjects.

Acronym

Effects of respiratory muscle stretch gymnastics in healthy subjects.

Scientific Title

Effects of respiratory muscle stretch gymnastics in term of respratory function, chest wall expansion, and respiratory muscle strength in healthy subjects.

Scientific Title:Acronym

Effects of respiratory muscle stretch gymnastics in term of respratory function, chest wall expansion, and respiratory muscle strength in healthy subjects.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify changes in respiratory function, chest wall expansion, and respiratory muscle strength before and after respiratory muscle stretch gymnastics in healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

respiratory muscle strength

Key secondary outcomes

pulmonary function, chest wall expansion


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

respiratory muscle stretch gymnastics (6 exercises, 4 times)

Interventions/Control_2

take a rest for the same amount of time as performing respiratory muscle stretch gymnastics

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


Not applicable

Gender

Male

Key inclusion criteria

healthy adults male aged ages 20 and over

Key exclusion criteria

those with respiratory disease
those who had a history of respiratory disease within one month
those with painful orthopedic diseases that can affecing respiratory muscle stretching gymnastics

Target sample size

50


Research contact person

Name of lead principal investigator

1st name AKIRA
Middle name
Last name MORINO

Organization

Hokkaido Chitose College of Rehabilitation

Division name

Department of Rehabilitation

Zip code

066-0055

Address

Satomi 2-10, Chitose, Hokkaido

TEL

0123-28-5331

Email

a-morino@chitose-reha.ac.jp


Public contact

Name of contact person

1st name AKIRA
Middle name
Last name MORINO

Organization

Hokkaido Chitose College of Rehabilitation

Division name

Department of Rehabilitation

Zip code

066-0055

Address

Satomi 2-10, Chitose, Hokkaido

TEL

0123-28-5331

Homepage URL


Email

a-morino@chitose-reha.ac.jp


Sponsor or person

Institute

Hokkaido Chitose College of Rehabilitation

Institute

Department

Personal name



Funding Source

Organization

Hokkaido Chitose College of Rehabilitation

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

Hokkaido chitose college of rehabilitation ethics committee

Address

Satomi 2-10, Chitose, Hokkaido

Tel

0123285331

Email

rinrishinsa@chitose-reha.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

2020 Year 01 Month 27 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

50

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

2019 Year 11 Month 22 Day

Date of IRB

2019 Year 12 Month 04 Day

Anticipated trial start date

2020 Year 01 Month 27 Day

Last follow-up date

2020 Year 10 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 01 Month 26 Day

Last modified on

2021 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044772


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name