UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000053044
Receipt number	R000060519
Scientific Title	The Impact of Respiratory Muscle Training on Ventilatory Function and
Date of disclosure of the study information	2023/12/12
Last modified on	2023/12/09 17:28:13

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Basic information

Public title

Effect of inspiratory muscle-loaded exercise training on ventilatory response and intercostal muscle deoxygenation during incremental cycling exercise

Acronym

Inspiratory muscle-loaded exercise training Impact study

Scientific Title

The Impact of Respiratory Muscle Training on Ventilatory Function and

Scientific Title:Acronym

Respiratory Muscle Training Ventilation Effect Study

Region

Japan

Condition

healthy person

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

This study aims to investigate whether the training that loads the inspiratory muscles during exercise affects exercise capacity, respiratory response during exercise, tissue oxygenation levels in the respiratory muscles, and respiratory regulation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

Respiratory metabolic response, as determined by exhaled gas analysis during incremental load exercise, before and after a 4-week exercise training regimen using a bicycle ergometer at 60% of maximal oxygen uptake.

Key secondary outcomes

Respiratory muscle strength, endurance, and function measured using an autospirometry.
Oxygenated and deoxygenated hemoglobin level in the intercostal muscles, assessed using near-infrared spectroscopy.
ypoxic ventilatory chemosensitivity evaluated through the rebreathing method.

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

YES

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

Participants will undergo a 4-week intervention, consisting of bicycle ergometer exercise sessions four times per week. Each session will last 20 minutes, performed at 60% of maximal intensity. During the exercise, participants will breathe through a PowerBreathe device set to 50% of their maximal inspiratory load.

Interventions/Control_2

Participants will undergo a 4-week intervention, consisting of bicycle ergometer exercise sessions four times per week. Each session will last 20 minutes, performed at 60% of maximal intensity.

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

Not applicable

Gender

Male

Key inclusion criteria

Healthy, exercise-trained adult males.

Key exclusion criteria

Exclusion criteria include individuals with a history of respiratory or cardiovascular diseases, and smokers.

Target sample size

Research contact person

Name of lead principal investigator

1st name Takeshi

Middle name

Last name Ogawa

Organization

Osaka Kyoiku University

Division name

Division of Art, Music and Physical Education

Zip code

582-8582

Address

Asahigaoka 4-698-1, Kashiwara city Osaka, Japan

TEL

072(978)3751

Email

ogawat@cc.osaka-kyoiku.ac.jp

Public contact

Name of contact person

1st name Takeshi

Middle name

Last name Ogawa

Organization

Osaka Kyoiku University

Division name

Division of Art, Music and Physical Education

Zip code

582-8582

Address

Asahigaoka 4-698-1, Kashiwara city Osaka, Japan

TEL

072(978)3751

Homepage URL

Email

ogawat@cc.osaka-kyoiku.ac.jp

Sponsor or person

Institute

Osaka Kyoiku University

Institute

Department

Personal name

Funding Source

Organization

JSPS

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

Osaka Kyoiku University

Address

Asahigaoka 4-698-1, Kashiwara city Osaka, Japan

Tel

072(978)3217

Email

kenkyo@bur.osaka-kyoiku.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2023 Year 12 Month 12 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

Delay expected

Results Delay Reason

The paper is currently under submission and remains unpublished.

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

2021 Year 04 Month 05 Day

Date of IRB

2020 Year 12 Month 17 Day

Anticipated trial start date

2021 Year 04 Month 05 Day

Last follow-up date

2021 Year 12 Month 20 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2023 Year 12 Month 09 Day

Last modified on

2023 Year 12 Month 09 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060519

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name