Hyperbaric Oxygenation in Athletes: Standard Versus Low Pressure
Sleutelwoorden
Abstract
Omschrijving
Subjects will be recruited through public announcements in local gyms and gathered to explain the protocol. Those willing to participate will sign a written informed consent and recruited. To be included, all the subjects will undergo a general medical screening to allow hyperbaric treatments. This will include weight, height, non-invasive arterial blood pressure, and heart rate measurements.
After inclusion, subjects will be randomly assigned to three arms using an electronic number generator by personnel not directly involved in the experiment:
- Arm 1(control): no intervention.
- Arm 2 (L-HBO): treated with oxygen at 1.45 ATA for 60 min (inclusive of compression and decompression times, and an air break of 3 minutes breathing air);
- Arm 3 (HBO): treated with oxygen at 2.5 ATA for 60 min (inclusive of compression and decompression times, and an air break of 3 minutes breathing air).
Subjects included in Arm 2 and 3 will undergo a total of 20 treatments. They will follow a personalized diet proportional to their energetic expenditure.
The Authors will identify 5 time-points in the protocol:
TIME 0 (T0): immediately after inclusion, before any treatment or experiment; TIME 1 (T1): standardized physical exercise 1, before HBO treatments; TIME 2 (T2): after HBO treatments ; TIME 3 (T3): standardized physical exercise 2, after the end of HBO treatments; TIME 4 (T4): 2 months after the end of HBO treatments.
The following exams will be performed on the included subjects:
- at T1 and T3, subjects will undergo a standardized physical stress test on a treadmill. Subjects will start with a fast walking at 4 km/h for 5 minutes, then will start running at 8 km/h for 3 minutes, and then speed will increase 2 km/h every 3 minutes until VO2 max or exhaustion is reached. Lactate production will be measured on capillary blood through finger stick at basal levels (before exercise), at the maximal threshold (VO2 max or exhaustion), then 5, 10, 15, 20, and 30 minutes after stopping the exercise while walking at 4 km/h (dynamic cool down).
- a standardized panel including Complete Blood Count (CBC), creatinine, Blood Urea Nitrogen (BUN), C reactive protein, and VES will be performed at T0, T2, and T4.
- oxidative stress markers will be analyzed on blood and urine samples, taken at several steps during the experimental period. On blood samples (T0; T1; T3), the Authors will measure IL-1 beta, IL-6, TNF-alfa, reactive oxygen species and total antioxidant capacity (by paramagnetic resonance), nitrite and nitrate (NO2/NO3) plasma concentration (by colorimetry based on the Griess reaction), inducible Nitric Oxide Synthase (by ELISA commercially available kit), total (tot) and reduced (red) aminothiols (by fluorescence spectroscopy). On urine samples (T0; T2; T4), the Authors will assess lipid peroxidation by measuring 8-isoprostane concentration (by competitive immunoassay).
Blood samples (approximately 6 ml) will be drawn from the veins of the forearms (preferentially on the non-dominant limb); plasma and erythrocytes will be separated by centrifuge at 1000×g for 10 min at 4°C. Urine samples will be collected by voluntary voiding in sterile containers. All samples will be stored in multiple aliquots at − 80 °C until assayed and thawed only once before analysis.
With this setting, blinding of patients and investigators will be impossible due to different structural characteristics. However, outcome assessors will be blinded to patients' allocation.
Datums
| Laatst geverifieerd: | 03/31/2020 |
| Eerste ingediend: | 03/03/2020 |
| Geschatte inschrijving ingediend: | 04/26/2020 |
| Eerst geplaatst: | 04/27/2020 |
| Laatste update ingediend: | 04/26/2020 |
| Laatste update geplaatst: | 04/27/2020 |
| Werkelijke startdatum van het onderzoek: | 03/02/2020 |
| Geschatte primaire voltooiingsdatum: | 04/30/2020 |
| Geschatte voltooiingsdatum van het onderzoek: | 05/31/2020 |
Conditie of ziekte
Interventie / behandeling
Combination Product: Low-pressure hyperbaric oxygenation (L-HBO)
Combination Product: Standard-pressure hyperbaric oxygenation (L-HBO)(HBO)
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: Low-pressure hyperbaric oxygenation (L-HBO) Low-pressure hyperbaric oxygen administration at 1.45 ATA for 60 minutes, inclusive of compression and decompression times, and a 3-minute air pause at the midtime. For a total of 20 sessions (3-4 per week). | Combination Product: Low-pressure hyperbaric oxygenation (L-HBO) as previously described. |
| Experimental: Standard-pressure hyperbaric oxygenation (L-HBO)(HBO) Standard pressure hyperbaric oxygen administration at 2.5 ATA for 60 minutes, inclusive of compression and decompression times, and a 3-minute air pause at the midtime. For a total of 20 non-consecutive sessions (3-4 per week). | Combination Product: Standard-pressure hyperbaric oxygenation (L-HBO)(HBO) as previously described. |
| No Intervention: Control Control group of athletes, no intervention. |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | Male |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | Inclusion Criteria: - professional athletes - performing at least 3 training sessions/week Exclusion Criteria: - previous pneumothorax - problems with compensation maneuvers - known epilepsy - active smoker |
Resultaat
Primaire uitkomstmaten
1. Reactive oxygen species production [On blood: Change from Baseline (T0) Reactive oxygen species production after the exercise test (Time 1: the day after baseline measurements), and at the completion of treatments after a second exercise test (Time 3: 5 weeks after the baseline)]
2. Total antioxidant capacity [On blood: Change from Baseline (T0) Total antioxidant capacity after the exercise test (Time 1: the day after baseline measurements), and at the completion of treatments after a second exercise test (Time 3: 5 weeks after the baseline)]
3. nitrite and nitrate (NO2/NO3) plasma concentration [On blood: Change from Baseline (T0) nitrite and nitrate (NO2/NO3) plasma concentration after the exercise test (Time 1: the day after baseline m), and at the completion of treatments after a second exercise test (Time 3: 5 weeks after the baseline)]
4. inducible Nitric Oxide Synthase [On blood: Change from Baseline (T0) inducible Nitric Oxide Synthase after the exercise test (Time 1:the day after baseline measurements), and at the completion of treatments after a second exercise test (Time 3: 5 weeks after the baseline)]
5. aminothiols [On blood: Change from Baseline (T0) aminothiols concentration after the exercise test (Time 1: the day after baseline measurements), and at the completion of treatments after a second exercise test (Time 3: 5 weeks after the baseline)]
6. Cytokines [On blood: Change from Baseline (T0) Cytokines levels after the exercise test (Time 1: the day after baseline measurements), and at the completion of treatments after a second exercise test (Time 3: 5 weeks after the baseline)]
7. lipid peroxidation [On Urine: Change from Baseline (T0) lipid peroxidation levels at one month (at the end of the treatments - Time 2), and two months after the end of the treatment (Time 4). Please see protocol for further details about "Ts"]
Secundaire uitkomstmaten
1. Lactic Acid Clearance [During the exercise we will assess lactic acid (by finger stick) at basal level, at the peak (reaching exhaustion: 80% of maximal cardiac frequency/ VO2 max/ subjective exhaustion), then at 5 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes.]
