NCT02356900

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

April 12, 2017

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

February 2, 2015

Results QC Date

March 1, 2017

Last Update Submit

April 12, 2017

Conditions

Exercise Training

Keywords

interval traininghyperbaric oxygenVO2 maxaltitudeexercise performancemitochondrial oxidative capacitymitochondrial biogenesis

Outcome Measures

Primary Outcomes (7)

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

    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)

    Graded exercise test to exhaustion at simulated 15000 ft altitude

    Baseline and <72 hrs Post-training

  • Mitochondrial Mass Change

    Immunofluorescence microscopy using citrate synthase staining

    Baseline/24 hrs Post-training

  • Tfam Muscle Protein Content Change

    Western analysis

    Baseline/24 hrs Post-training

  • Pgc-1a Coactivator Muscle Protein Content Change

    Western analysis

    Baseline/24 hrs Post-training

  • COX-I Gene Expression Change

    Real-time PCR

    Baseline/24 hrs Post-training

  • Muscle Phenotype Change

    Immunofluorescence microscopy using citrate synthase staining

    Baseline/24 hrs Post-training

Study Arms (2)

Hyperoxic, Hyperbaric

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.

Procedure: Hyperoxic hyperbaric interval exercise trainingDrug: Oxygen

Normoxic, Normobaric

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.

Procedure: Normoxic, normobaric, interval exercise training

Interventions

Hyperoxic hyperbaric interval exercise trainingPROCEDURE

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

Hyperoxic, Hyperbaric
Normoxic, normobaric, interval exercise trainingPROCEDURE

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

Normoxic, Normobaric
OxygenDRUG

Used in Hyperoxic hyperbaric interval exercise training intervention

Hyperoxic, Hyperbaric

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, recreationally active or sedentary individuals

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Alvarez Villela M, Dunworth SA, Kraft BD, Harlan NP, Natoli MJ, Suliman HB, Moon RE. Effects of high-intensity interval training with hyperbaric oxygen. Front Physiol. 2022 Aug 19;13:963799. doi: 10.3389/fphys.2022.963799. eCollection 2022.

    PMID: 36060678DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Results Point of Contact

Title
Richard Moon, MD
Organization
Duke University Medical School
richard.moon@duke.edu
919-684-6726

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 5, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2017

Results First Posted

April 12, 2017

Record last verified: 2017-04

Locations

US(1)