Hyperbaric VO2max Study

April 12, 2017 updated by: Duke University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Drug: Oxygen
Used in Hyperoxic hyperbaric interval exercise training intervention
Sham Comparator: 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.
Procedure: Normoxic, normobaric, interval exercise training
Six 30-min high-intensity interval training sessions completed 3-times a week.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00060147

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.

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