Hyperbaric VO2max Study

Exercise Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02356900
• Other study ID #: Pro00060147
• Status: Terminated
• Phase: Phase 2
• First received: February 2, 2015
• Last updated: January 10, 2017
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Exercise Training

Intervention

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.
• Normoxic, normobaric, interval exercise training
Six 30-min high-intensity interval training sessions completed 3-times a week.

Drug:
• Oxygen
Used in Hyperoxic hyperbaric interval exercise training intervention

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum aerobic capacity (VO2max) change	Graded exercise test to exhaustion at simulated 15000 ft altitude	Baseline/48 - 72 hrs Post-training	No
Primary	Mitochondrial mass change	Immunofluorescence microscopy using citrate synthase staining	Baseline/24 hrs Post-training	No
Primary	Tfam muscle protein content change	Western analysis	Baseline/24 hrs Post-training	No
Primary	Pgc-1a coactivator muscle protein content change	Western analysis	Baseline/24 hrs Post-training	No
Primary	COX-I gene expression change	Real-time PCR	Baseline/24 hrs Post-training	No
Primary	Ventilatory threshold (VT) change	Graded exercise test to exhaustion at simulated 15000 ft altitude	Baseline/48 - 72 hrs Post-training	No
Primary	Muscle phenotype change	Immunofluorescence microscopy using citrate synthase staining	Baseline/24 hrs Post-training	No