Hyperbaric VO2max Study

Phase 2

Terminated

• Conditions: Exercise Training
• Interventions: Procedure: Normoxic, normobaric, interval exercise training; Procedure: Hyperoxic hyperbaric interval exercise training; Drug: Oxygen

• Registration Number: NCT02356900
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-03-01
• Results First Submitted QC: 2017-03-01
• Status Verified: 2017-04
• Results First Posted: 2017-04-12
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normoxic, Normobaric	Normoxic, normobaric, interval exercise training	Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Hyperoxic, Hyperbaric	Hyperoxic hyperbaric interval exercise training	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	Oxygen	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.

Primary Outcome Measures

Name	Time	Method
Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)	Baseline and <72 hrs Post-training	Graded exercise test to exhaustion at simulated 15000 ft altitude
COX-I Gene Expression Change	Baseline/24 hrs Post-training	Real-time PCR
Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )	Baseline and <72 hrs Post-training	Graded exercise test to exhaustion at simulated 15000 ft altitude
Pgc-1a Coactivator Muscle Protein Content Change	Baseline/24 hrs Post-training	Western analysis
Muscle Phenotype Change	Baseline/24 hrs Post-training	Immunofluorescence microscopy using citrate synthase staining
Mitochondrial Mass Change	Baseline/24 hrs Post-training	Immunofluorescence microscopy using citrate synthase staining
Tfam Muscle Protein Content Change	Baseline/24 hrs Post-training	Western analysis

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States