Overview

This trial is active, not recruiting.

Condition exercise training
Treatments hyperoxic hyperbaric interval exercise training, normoxic, normobaric, interval exercise training, oxygen
Phase phase 2
Sponsor Duke University
Start date February 2015
End date December 2016
Trial size 25 participants
Trial identifier NCT02356900, Pro00060147

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
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
(Sham Comparator)
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.

Primary Outcomes

Measure
Maximum aerobic capacity (VO2max) change
time frame: Baseline/48 - 72 hrs Post-training
Mitochondrial mass change
time frame: Baseline/24 hrs Post-training
Tfam muscle protein content change
time frame: Baseline/24 hrs Post-training
Pgc-1a coactivator muscle protein content change
time frame: Baseline/24 hrs Post-training
COX-I gene expression change
time frame: Baseline/24 hrs Post-training
Ventilatory threshold (VT) change
time frame: Baseline/48 - 72 hrs Post-training
Muscle phenotype change
time frame: Baseline/24 hrs Post-training

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title Effects of High Intensity Interval Training in a Hyperoxic-hyperbaric Environment on Exercise Performance at Altitude
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Duke University.