Effect of hyperbaric oxygen on recovery from exercise-induced fatigue

ISRCTN ISRCTN81080077
DOI https://doi.org/10.1186/ISRCTN81080077
Secondary identifying numbers 12345
Submission date
07/01/2025
Registration date
14/01/2025
Last edited
13/01/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Although insufficient delivery of oxygen might be a factor in physical and perceived fatigue, the relationship between exposure to hyperbaric oxygen (HBO, delivery of oxygen at a pressure greater than normal) and recovery from perceived fatigue remains unexplained. The purpose of this study was to investigate the effects of exposure to HBO after long-duration, medium-intensity training on recovery from perceived fatigue.

Who can participate?
Healthy male university students who exercised regularly, aged 20 to 30 years of age

What does the study involve?
Fatigue is induced using an exercise bike at a moderate intensity of 75% of maximum heart rate for 60 minutes. After the workout, participants randomly receive an intervention comprising exposure to HBO or an air placebo in a single-blind experimental trial. Blood tests are conducted and perceived fatigue is evaluated at five time points. One week later, participants switch to the other intervention and repeat the study.

What are the possible benefits and risks of participating?
The possible benefits will be an improvement in recovery from fatigue. The possible risks include otitis media with effusion (ear fluid buildup), perforated (burst) eardrums and pneumothorax (collapsed lung), but pneumothorax is extremely rare.

Where is the study run from?
Tokyo Medical and Dental University (Japan)

When is the study starting and how long is it expected to run for?
November 2010 to August 2014

Who is funding the study?
Tokyo Medical and Dental University (Japan)

Who is the main contact?
Kazuyoshi Yagishita, yagishita.orth@tmd.ac.jp

Contact information

Prof Kazuyoshi Yagishita
Public, Scientific, Principal Investigator

1-5-45 Yushima, Bunkyo-ku
Tokyo
1138519
Japan

ORCiD logoORCID ID 0000-0003-3809-8931
Phone +81-3-5803-5341
Email yagishita.orth@tmd.ac.jp

Study information

Study designSingle-blind crossover randomized trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleEffect of hyperbaric oxygen after moderate-intensity exercise on fatigue: a single-blind crossover randomized trial
Study objectivesHyperbaric oxygen will reduce fatigue after long-duration, moderate-intensity exercise.
Ethics approval(s)

Approved 27/12/2011, Institutional review board of Tokyo Medical and Dental University (1-5-45 Yushima, Bunkyo-ku, Tokyo, 1138519, Japan; +81-3-5803-4547; rinri.adm@tmd.ac.jp), ref: 2000-901

Health condition(s) or problem(s) studiedHealthy participants with fatigue after moderate-intensity exercise
InterventionThe study used a crossover design in which all subjects received both the hyperbaric oxygen (HBO) intervention and air placebo following with an interval of 1 week. The subjects were randomly assigned to either the HBO or placebo air group. In the initial trial, five subjects received HBO treatment and four received placebo. Subsequently, in the crossover trial, four subjects received HBO treatment and five received placebo.

The HBO intervention protocol consisted of 60 min of inhaling pure oxygen using a mask at pressures up to 2.5 ATA with two 5-minute breaks to breathe air, 15 min for compression and 15 min for decompression for a total of 100 min.

The intervention for air placebo consisted of 80 min of breathing air at pressures up to 1.2 ATA, with 10 min for compression and 10 min for decompression, for a total of 100 min.

Fatigue was induced using an ergometer exercise bike at a moderate intensity of 75% of their maximum heart rate for 60 min. Post-workout, subjects randomly received an intervention comprising exposure to hyperbaric oxygen (HBO) or an air placebo in a single-blind trial.

Blood tests were conducted and perceived fatigue was evaluated by using visual analog scales (VAS) at five timepoints. Blood tests and VAS scores for fatigue were measured pre-exercise, post-exercise, post-intervention, 1.5 hours post-intervention, and 24 hours post-intervention. One week later, a crossover was conducted.
Intervention typeOther
Primary outcome measureWhole-body fatigue and leg fatigue were measured using the visual analogue score (VAS) at pre-exercise (test 1), post-exercise (test 2), post-intervention (test 3), 1.5 h post-intervention (test 4), and 24 hours post-intervention (test 5).
Secondary outcome measuresMuscle fatigue, inflammation, and the immune system assessed using blood tests at pre-exercise (test 1), post-exercise (test 2), post-intervention (test 3), 1.5 h post-intervention (test 4), and 24 hours post-intervention (test 5).
Overall study start date30/11/2010
Completion date01/08/2014

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit20 Years
Upper age limit30 Years
SexMale
Target number of participants9
Total final enrolment9
Key inclusion criteriaHealthy male university students who exercised regularly
Key exclusion criteria1. Participant had difficulty relieving pressure in their ears (which precludes or makes HBO treatment difficult)
2. Claustrophobia
3. Congenital pulmonary cysts
4. Asthma
5. History of pneumothorax or heart disease
6. Experienced heart palpitations, precordial pain, or tachycardia during the previous year
Date of first enrolment01/08/2012
Date of final enrolment01/08/2013

Locations

Countries of recruitment

  • Japan

Study participating centre

Tokyo Medical and Dental University
1-5-45 Yushima, Bunkyo-ku
Tokyo
1138519
Japan

Sponsor information

Tokyo Medical and Dental University
University/education

1-5-45 Yushima, Bunkyo-ku
Japan
1138519
Japan

Phone +81-3-5803-4547
Email rinri.adm@tmd.ac.jp
Website http://www.tmd.ac.jp/english/
ROR logo "ROR" https://ror.org/051k3eh31

Funders

Funder type

University/education

Tokyo Medical and Dental University
Government organisation / Local government
Alternative name(s)
TMDU
Location
Japan

Results and Publications

Intention to publish date31/12/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer-reviewed academic journal
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available because this clinical trial was conducted until 2013, and because the informed consent at the time did not obtain consent from the test participants regarding the publication of the data. The datasets generated during and/or analysed during the current study will be stored in the PC of the corresponding author.

Editorial Notes

13/01/2025: Study's existence confirmed by the institutional review board of Tokyo Medical and Dental University.