- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551869
Oxygen as a Metabolic Modulator: Divergent Physiological Adaptations to Hypoxic and Hyperoxic Tabata Training.
The purpose of this study is to examine how breathing air with different oxygen concentrations (higher or lower than normal) during high-intensity interval training affects:
- Aerobic capacity (VO₂max)
- Ventilatory thresholds
- Blood lactate levels
- Perceived exertion This research aims to better understand how oxygen availability influences physiological adaptations to exercise.
If you agree to participate, you will undergo the following:
Baseline testing:
- Cardiopulmonary exercise test (cycling until exhaustion)
- Measurement of oxygen consumption, heart rate, and ventilatory thresholds
- Blood lactate measurement (finger prick)
Training intervention (3 weeks):
- 3 sessions per week (total of 9 sessions)
- High-intensity interval training (Tabata protocol: 8 × 20 seconds effort / 10 seconds rest)
- Exercise performed on an air-resistance cycle ergometer
During training, you will breathe either:
- Hyperoxic air (high oxygen concentration) or
- Hypoxic air (low oxygen concentration) You will be randomly assigned to one of these conditions.
Post-intervention testing:
• Same assessments as baseline
The risks associated with this study are similar to those encountered during high-intensity exercise:
- Fatigue
- Muscle soreness
- Shortness of breath
- Temporary discomfort from finger-prick blood sampling
Breathing altered oxygen concentrations (hypoxia or hyperoxia) may induce:
- Mild dizziness
- Increased breathing effort (hypoxia)
- Sensations of ease or altered effort perception (hyperoxia) All sessions are supervised by trained personnel, and safety monitoring is ensured throughout the study
You may benefit from:
- Improved physical fitness
- Detailed physiological assessment (VO₂max, thresholds) However, no direct health benefit is guaranteed. Your participation is entirely voluntary.
- You may withdraw at any time
- You do not need to provide a reason
- Withdrawal will not affect your academic or professional standing
All collected data will be:
- Anonymized
- Stored securely
- Used only for research purposes Your identity will not be disclosed in any publication. Data will be handled in accordance with applicable data protection regulations (GDPR).
You have the right to:
- Access your data
- Request correction or deletion where applicable
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brussels Capital
-
Brussels, Brussels Capital, Belgium, 1040
- Haute Ecole Bruxelles Brabant - HE2B
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- recreationally active
- male
- 18-35 years old
Exclusion Criteria:
- engaged in professional or elite-level sports training
- cardiovascular, pulmonary, metabolic, or neurological disease
- taking medications known to influence cardiovascular or metabolic responses to exercise To minimize potential confounding factors, participants were instructed to refrain from strenuous physical activity, alcohol consumption, caffeine intake, and smoking for at least 24 hours before each testing session, in accordance with standard exercise testing procedures recommended in exercise physiology guidelines
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hyperoxia group
inspired oxygen fraction (FiO₂) = 0.60 during Tabatha protocol
|
Normobaric hyperoxic breathing during high-intensity interval training (FiO2 0.60) and hypoxic (FiO2 0.16)
|
|
Experimental: Hypoxia group
inspired oxygen fraction (FiO₂) = 0.16 during Tabatha protocol
|
Normobaric hyperoxic breathing during high-intensity interval training (FiO2 0.60) and hypoxic (FiO2 0.16)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maximal oxygen uptake (VO₂max)
Time Frame: From enrollment to the end of protocol at 3 weeks
|
VO2max represents the maximal rate at which an individual can consume oxygen during incremental exercise.
It is measured during a graded exercise test (e.g., treadmill or cycle ergometer) using indirect calorimetry.
It reflects aerobic capacity and cardiovascular fitness.
Higher values indicate better aerobic performance and endurance capacity.
|
From enrollment to the end of protocol at 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the first and second ventilatory thresholds (VT1, VT2)
Time Frame: from enrollment to the end of the protocol at 3 weeks
|
VT1 (first ventilatory threshold) corresponds to the exercise intensity at which ventilation begins to increase disproportionately relative to oxygen uptake, indicating the onset of lactate accumulation.
VT2 (second ventilatory threshold) marks a further disproportionate increase in ventilation due to metabolic acidosis.
These thresholds are determined from gas exchange analysis during exercise testing and reflect submaximal aerobic and anaerobic transition points.
|
from enrollment to the end of the protocol at 3 weeks
|
|
peak blood lactate
Time Frame: from enrollment to the end of protocol at 3 weeks
|
Peak blood lactate is the highest concentration of lactate measured in the blood during or immediately after maximal exercise.
It is assessed via capillary or venous blood sampling.
This measure reflects the degree of anaerobic metabolism and glycolytic contribution during high-intensity effort.
|
from enrollment to the end of protocol at 3 weeks
|
|
session rating of perceived exertion (RPE).
Time Frame: from enrollment to the end of the protocol at 3 weeks
|
RPE is a subjective measure of exercise intensity based on an individual's perception of effort, typically assessed using standardized scales such as the Borg scale (6-20 or 0-10).
It integrates physiological and psychological responses to exercise and is useful for monitoring training load and tolerance.
|
from enrollment to the end of the protocol at 3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clément Levêque, PhD, HE2B
Publications and helpful links
General Publications
- Balestra C, Lambrechts K, Mrakic-Sposta S, Vezzoli A, Levenez M, Germonpre P, Virgili F, Bosco G, Lafere P. Hypoxic and Hyperoxic Breathing as a Complement to Low-Intensity Physical Exercise Programs: A Proof-of-Principle Study. Int J Mol Sci. 2021 Sep 4;22(17):9600. doi: 10.3390/ijms22179600.
- Balestra C, Mrakic-Sposta S, Virgili F. Oxygen Variations-Insights into Hypoxia, Hyperoxia and Hyperbaric Hyperoxia-Is the Dose the Clue? Int J Mol Sci. 2023 Aug 30;24(17):13472. doi: 10.3390/ijms241713472.
- Balestra C, Kot J. Oxygen: A Stimulus, Not "Only" a Drug. Medicina (Kaunas). 2021 Oct 25;57(11):1161. doi: 10.3390/medicina57111161.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B200-2020-088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on High Intensity Interval Training
-
European University Miguel de CervantesHospital Clínico Universitario de ValladolidRecruitingHigh Intensity Interval Training (Cycling) | High Intensity Interval Training (Running) | High Intensity Functional Training | Moderate Intensity Functional Training | High Intensity Traditional Strength Training | Moderate Intensity Traditional Strength TrainingSpain
-
University of Central LancashireUniversity of HullCompletedHigh Intensity Interval TrainingUnited Kingdom
-
University of MiamiCompletedResistance Training | High-Intensity Interval TrainingUnited States
-
Riphah International UniversityRecruiting
-
University of NottinghamCompletedHigh-Intensity Interval TrainingUnited Kingdom
-
Teesside UniversityCompleted
-
University of North Carolina, Chapel HillNational Institute for Occupational Safety and Health (NIOSH/CDC)CompletedHigh Intensity Interval Training | FirefighterUnited States
-
University of Health Sciences LahoreRecruitingHigh Intensity Interval TrainingPakistan
-
University of BathCompletedHigh-Intensity Interval TrainingUnited Kingdom
-
Teesside UniversityLiverpool John Moores UniversityCompletedHigh-intensity Interval Training