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Hyperbaric VO2max Study

Effects of High Intensity Interval Training in a Hyperoxic-hyperbaric Environment on Exercise Performance at Altitude

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02356900
Enrollment
25
Registered
2015-02-05
Start date
2015-02-28
Completion date
2016-05-31
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Training

Keywords

interval training, hyperbaric oxygen, VO2 max, altitude, exercise performance, mitochondrial oxidative capacity, mitochondrial biogenesis

Brief summary

This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric environment for exercise performance at altitude. Subjects will complete a short, high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and after this training phase, all subjects will be tested for maximum aerobic capacity at a simulated high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers of mitochondrial oxidative capacity in a skeletal muscle biopsy. A group of individuals of similar characteristics completing this training program in a normoxic-normobaric environment will serve as a control.

Interventions

PROCEDUREHyperoxic hyperbaric interval exercise training

Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.

PROCEDURENormoxic, normobaric, interval exercise training

Six 30-min high-intensity interval training sessions completed 3-times a week.

DRUGOxygen

Used in Hyperoxic hyperbaric interval exercise training intervention

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy, recreationally active or sedentary individuals

Exclusion criteria

* VO2max \< 35 ml/kg/min - male 30 ml/kg/min - female * chronic cardiovascular or pulmonary diseases * history of pneumothorax * active smoker * pregnant women * non-english speaking * not in full mental capacity * blind * sickle cell trait or disease

Design outcomes

Primary

MeasureTime frameDescription
Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )Baseline and <72 hrs Post-trainingGraded exercise test to exhaustion at simulated 15000 ft altitude
Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)Baseline and <72 hrs Post-trainingGraded exercise test to exhaustion at simulated 15000 ft altitude
Mitochondrial Mass ChangeBaseline/24 hrs Post-trainingImmunofluorescence microscopy using citrate synthase staining
Tfam Muscle Protein Content ChangeBaseline/24 hrs Post-trainingWestern analysis
Pgc-1a Coactivator Muscle Protein Content ChangeBaseline/24 hrs Post-trainingWestern analysis
COX-I Gene Expression ChangeBaseline/24 hrs Post-trainingReal-time PCR
Muscle Phenotype ChangeBaseline/24 hrs Post-trainingImmunofluorescence microscopy using citrate synthase staining

Countries

United States

Participant flow

Pre-assignment details

25 participants were consented. 21 were randomized and completed the study, 1 was a screen failure, 1 withdrew after the initial biopsy and rash from bandage adhesive, 1 was withdrawn due to schedule noncompliance, and one was withdrawn after a syncopal episode during the initial biopsy.

Participants by arm

ArmCount
Hyperoxic, Hyperbaric
Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber. Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber. Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention
11
Normoxic, Normobaric
Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis. Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week.
10
Total21

Baseline characteristics

CharacteristicHyperoxic, HyperbaricTotalNormoxic, Normobaric
Age, Continuous25.0 years
STANDARD_DEVIATION 4.5
25.4 years
STANDARD_DEVIATION 4.6
25.9 years
STANDARD_DEVIATION 4.8
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants20 Participants9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
3 Participants3 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
8 Participants17 Participants9 Participants
Region of Enrollment
United States
11 participants21 participants10 participants
Sex: Female, Male
Female
3 Participants9 Participants6 Participants
Sex: Female, Male
Male
8 Participants12 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 10
other
Total, other adverse events
0 / 111 / 10
serious
Total, serious adverse events
0 / 110 / 10

Outcome results

Primary

Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )

Graded exercise test to exhaustion at simulated 15000 ft altitude

Time frame: Baseline and <72 hrs Post-training

Population: Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.

ArmMeasureValue (MEAN)Dispersion
Hyperoxic, HyperbaricChange in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )3.8 mL/kg/minStandard Deviation 5
Normoxic, NormobaricChange in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )4.2 mL/kg/minStandard Deviation 4.9
Primary

Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)

Graded exercise test to exhaustion at simulated 15000 ft altitude

Time frame: Baseline and <72 hrs Post-training

Population: Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.

ArmMeasureValue (MEAN)Dispersion
Hyperoxic, HyperbaricChange in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)3.2 mL/kg/minStandard Deviation 4.9
Normoxic, NormobaricChange in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)2.3 mL/kg/minStandard Deviation 3.4
Primary

COX-I Gene Expression Change

Real-time PCR

Time frame: Baseline/24 hrs Post-training

Population: Muscle Biopsy samples were not analyzed due to funding issues.

Primary

Mitochondrial Mass Change

Immunofluorescence microscopy using citrate synthase staining

Time frame: Baseline/24 hrs Post-training

Population: Muscle Biopsy samples were not analyzed due to funding issues.

Primary

Muscle Phenotype Change

Immunofluorescence microscopy using citrate synthase staining

Time frame: Baseline/24 hrs Post-training

Population: Muscle Biopsy samples were not analyzed due to funding issues.

Primary

Pgc-1a Coactivator Muscle Protein Content Change

Western analysis

Time frame: Baseline/24 hrs Post-training

Population: Muscle Biopsy samples were not analyzed due to funding issues.

Primary

Tfam Muscle Protein Content Change

Western analysis

Time frame: Baseline/24 hrs Post-training

Population: Muscle Biopsy samples were not analyzed due to funding issues.

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026