UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041657 |
|---|---|
| Receipt number | R000047334 |
| Scientific Title | Effects of hyperbaric oxygen on recovery from fatigue and sleep after playing golf |
| Date of disclosure of the study information | 2020/09/02 |
| Last modified on | 2020/09/02 17:23:03 |
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Basic information
Public title
Effects of hyperbaric oxygen on recovery from fatigue and sleep after playing golf
Acronym
Effects of hyperbaric oxygen on recovery from fatigue and sleep after playing golf
Scientific Title
Effects of hyperbaric oxygen on recovery from fatigue and sleep after playing golf
Scientific Title:Acronym
Effects of hyperbaric oxygen on recovery from fatigue and sleep after playing golf
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether trying hyperbaric oxygen therapy after golf competition promotes the reduction of psychological fatigue and stress.
Basic objectives2
Others
Basic objectives -Others
To investigate how hyperbaric oxygen therapy after golf competition is reflected in neuropsychological test indicators and stress-related markers in blood and saliva.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hormones and inflammatory cytokines in saliva and plasma
Key secondary outcomes
Twin-dimensional Mood Scale-Short Team: TDMS-ST
Chalder Fatigue Scale Japanese-version: CFS
Phasic Stress Scale: PSS
Roken Arousal scale: RAS
Psychological Lively Scale-Revised: PLS-R
Subjective Well-Being Scale: SWBS
Beck Depression Inventory-2: BDI-2
International Physical Activity Questionnaire: IPAQ
Ratings of perceived exertion: RPE
OSA sleep inventory MA version
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
After Participants play golf, hyperbaric oxygen therapy will be performed. They intermittently breath 30% oxygen while the treatment chamber is pressurized to a pressure 1.25 atmosphere absolute for one hour.
Interventions/Control_2
Rest for one hour after playing golf.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
those with experiences of playing golf
Key exclusion criteria
(1) Patients with a history of spontaneous pneumothorax or bronchial asthma, open chest surgery, etc., who may have an acute ventilation disorder.
(2) Aspiration or suffocation, severe arrhythmia or other serious respiratory circulatory disorder
(3) Those who have a history of head injury with consciousness disorder, chronic lung disease, chronic kidney disease, chronic liver disease, thyroid disease, active cancer, cerebrovascular disease, epilepsy, neurological disease, substance-related disorder
(4) Person with a clear history of mental illness
(5) Those who may become pregnant during pregnancy, breastfeeding, or during the study period
(6) Person who boarded an aircraft and dive within 24 hours immediately before the intervention.
(7) People with a history of claustrophobia
(8) Those who cannot remove the ears or have nasal congestion
(9) Others, especially those whose participation is restricted by doctors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tshifumi |
| Middle name | |
| Last name | Kishimoto |
Organization
Nara Medical University
Division name
Department of psychiatry
Zip code
6348522
Address
840, Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
toshik@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Makinodan |
Organization
Nara Medical University
Division name
Department of psychiatry
Zip code
6348522
Address
840, Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
mmm@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Department of psychiatry
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Department of psychiatry
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
The human ethics committee of Nara Medical University
Address
840, Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-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
奈良県立医科大学附属病院 精神科（奈良県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | 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 | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047334
| Research Plan | |
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| Registered date | File name |
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