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 | 2024/11/05 22:11:27 |
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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
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
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
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
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
33
Results
Just after the exercise using a treadmill in young adults and using an ergometer in elderly person, subjects were administered oxygen produced by portable oxygen generator or compressed air in the manner of double-blind crossover study. In young adults, there were no differences in the recovery of any symptoms, vital signs, and blood lactic acid, however, the elderly persons showed a tendency to improve only the recovery of leg fatigue administered of oxygen.
Results date posted
| 2024 | Year | 11 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
13 young healthy adults consisted of 7 men and 6 ladies from 20 to 40 years of old and 20 elderly persons consisted of 3 men and 17 women over 60 years of old.
Participant flow
Young adults exercised using treadmill and Elderly persons exercised using ergometer to symptom limit, and just after exercise the subjects oxygen produced by oxygen generator that newly derived or compressed air as double-blind cross over study
Adverse events
none
Outcome measures
Borg-scale of breathlessness and leg fatigue, respiratory rate, heart rate, SpO2, PetCO2, and blood lactic acid.
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
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050169
