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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041657
Receipt No. 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

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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
Email 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
Email mmm@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Department of psychiatry
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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