Effect of hyperbaric oxygen on recovery from exercise-induced fatigue
| ISRCTN | ISRCTN81080077 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81080077 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 12345 |
| Sponsor | Tokyo Medical and Dental University |
| Funder | Tokyo Medical and Dental University |
- 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
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
Public, Scientific, Principal investigator
1-5-45 Yushima, Bunkyo-ku
Tokyo
1138519
Japan
 ORCID ID |
0000-0003-3809-8931 |
|---|---|
| Phone | +81-3-5803-5341 |
| yagishita.orth@tmd.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind crossover randomized trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Effect of hyperbaric oxygen after moderate-intensity exercise on fatigue: a single-blind crossover randomized trial |
| Study objectives | Hyperbaric 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) studied | Healthy participants with fatigue after moderate-intensity exercise |
| Intervention | The 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 type | Other |
| Primary outcome measure(s) |
Whole-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). |
| Key secondary outcome measure(s) |
Muscle 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). |
| Completion date | 01/08/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 30 Years |
| Sex | Male |
| Target sample size at registration | 9 |
| Total final enrolment | 9 |
| Key inclusion criteria | Healthy male university students who exercised regularly |
| Key exclusion criteria | 1. 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 enrolment | 01/08/2012 |
| Date of final enrolment | 01/08/2013 |
Locations
Countries of recruitment
- Japan
Study participating centre
Tokyo
1138519
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/01/2025: Study's existence confirmed by the institutional review board of Tokyo Medical and Dental University.
