UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043936
Receipt number R000050169
Scientific Title The effects of inspired oxygen from a portable oxygen generator just after sports on relieving fatigue.
Date of disclosure of the study information 2021/05/06
Last modified on 2023/10/17 13:30:42

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Basic information

Public title

Does the inspiration of oxygen from a portable oxygen generator just after sports relieve muscle fatigue and dyspnea?

Acronym

Efficacy of inspired oxygen just after sports.

Scientific Title

The effects of inspired oxygen from a portable oxygen generator just after sports on relieving fatigue.

Scientific Title:Acronym

Verification of a portable oxygen generator.

Region

Japan


Condition

Condition

Healthy adult volunteers

Classification by specialty

Pneumology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to examine the effects of inspiration of oxygen from the newly developed portable oxygen generator just after sports on relieving muscle fatigue and dyspnea

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

modified Borg Scale after exercise

Key secondary outcomes

Recovery time of SpO2, tcpCO2, respiratory rates, and pulse rates and the concentration of lactate 10 minutes after exercise.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

cross-over test

Interventions/Control_2

double blind placebo control study

Interventions/Control_3

inspiration of oxygen or bubbling air for 15 minute after exercise

Interventions/Control_4

The inspiration of oxygen or bubbling air leaving the intervals more than ten minutes are examined on the same day.

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adult volunteers

Key exclusion criteria

exclude the patients with cardiovascular diseases, arrhythmia impossible exercise test, respiratory disease such as asthma and lower lung function, difficulty in exercise due to motor or cognitive dysfunction and a pregnant woman or nursing woman.

Target sample size

37


Research contact person

Name of lead principal investigator

1st name Keisaku
Middle name
Last name Fujimoto

Organization

Shinshu University School of Medicine

Division name

Department of Health Sciences

Zip code

3908621

Address

3-1-1, Asahi, Matsumoto

TEL

09048291240

Email

fkeisaku@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Keisaku
Middle name
Last name Fujimoto

Organization

Shinshu University School of Mediine

Division name

Department of Health Sciences

Zip code

3908621

Address

3-1-1, Asahi, Matsumoto

TEL

09048291240

Homepage URL


Email

keisaku@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

collaborative research expenses provided from KIS co.,LTD located in Saku of Nagano prefecture.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the Shinshu University of Medical Ethics Committee

Address

3-1-1, Asahi, Matsumoto

Tel

0263372393

Email

mdrinri@shinshu-u.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

2021 Year 05 Month 06 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

Open public recruiting

Date of protocol fixation

2021 Year 04 Month 07 Day

Date of IRB

2021 Year 04 Month 08 Day

Anticipated trial start date

2021 Year 05 Month 06 Day

Last follow-up date

2023 Year 10 Month 28 Day

Date of closure to data entry

2023 Year 10 Month 29 Day

Date trial data considered complete

2023 Year 11 Month 07 Day

Date analysis concluded

2024 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 04 Month 15 Day

Last modified on

2023 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050169


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name