Effects of High-Intensity Interval Training (HIT) While in a Hyperoxic-Hyperbaric Environment on Exercise Performance (HITOP)

Effects of High-Intensity Interval Training (HIT) While in a Hyperoxic-Hyperbaric Environment on Exercise Performance (HITOP Study)

Hyperbaric oxygen has previously been tested as a possible means for pre-conditioning to enhance exercise performance. This study is designed to examine the effects of exercising in a hyperbaric chamber for improving fitness when combined with high-intensity training.

Study Overview

• Status: Completed
• Conditions: Exercise Performance
• Intervention / Treatment: Other: Ambient pressure; Other: Hyperbaric chamber

Detailed Description

The purpose of this research study is to determine the incremental benefit of high intensity interval training (HIT) in a hyperbaric-hyperoxic environment with HIT alone in healthy subjects and to compare the effect of HIT at an intermediate altitude (SLC, UT; altitude 1420 m) with that performed at sea-level (Durham, NC) in healthy subjects. While VO2 max is determined by the functional interdependence of the respiratory, cardiovascular and muscular systems, ultimately VO2 max is determined by mitochondrial oxidative capacity. Exercise training increases mitochondrial capacity. There is evidence that high intensity interval training (HIT) programs are effective at increasing exercise capacity. Furthermore, there is evidence that training while in a hyperbaric-hyperoxic environment may potentiate the HIT training effect through its effects on mitochondrial oxidative capacity, but this has not been scientifically tested. Our hypothesis is that high intensity interval training (HIT) in a hyperoxichyperbaric environment performed six-times over a two-week period will increase exercise performance compared with HIT performed in ambient conditions in healthy subjects. The primary outcome studied will be the effect of high-volume interval training in a hyperbaric-hyperoxic on VO2max.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy individuals, ages 18-40 years that are sedentary or recreationally active but not involved in any structured endurance training will be eligible for the study. This level of activity will be defined as performing mild-moderate aerobic exercise 0-3 times per week.
• VO2 max within normal limits (defined as 84-120% predicted using Wasserman reference equations48).
• Spirometry within predicted limits.

Exclusion Criteria:

• Subjects unable to complete a satisfactory VO2 max test
• Individuals with chronic cardiovascular disease such as hypertension, valve disease, coronary artery disease, cardiac conduction abnormalities, etc.
• History of pneumothorax or chronic lung disease such as asthma, COPD, bronchiectasis
• Active Smokers
• Pregnant women
• Persons unable to read or understand English, not in full mental capacity or suffer from blindness.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ambient pressure arm; High intensity training will be completed while the subjects are breathing normal air.	Other: Ambient pressure
Experimental: Hyperoxic-hyperbaric arm; The high intensity training program will be carried out in a hyperbaric chamber.	Other: Hyperbaric chamber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximum VO2 at 2 weeks compared to baseline	Comparison of post-training VO2 results with baseline in the two HIT groups (performed at ambient conditions in Salt Lake City, UT and hyperbarichyperoxic conditions); the results of HIT at Salt Lake City, UT altitude will be compared with those performed at sea-level altitude in Durham, NC.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VO2 measured at anaerobic threshold (in mL O2/kg/min) at 2 weeks compared to baseline	Difference post-training minus pre-training	2 weeks
ΔVO2/ΔWR (in mL O2/kg/min/Watt; a measure of exercise efficiency)	Difference post-training minus pre-training	2 weeks
Change in peak work rate (in Watts) at 2 weeks compared to baseline	Difference post-training minus pre-training	2 weeks
Change in heart rate response to exercise at 2 weeks compared with baseline	Difference post-training minus pre-training	2 weeks
Change in level of perceived exertion at 2 weeks compared with baseline	Difference post-training minus pre-training	2 weeks
Change in Borg dyspnea score at 2 weeks compared with baseline	Difference post-training minus pre-training	2 weeks

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Matt Hegewald, MD, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2016
• Primary Completion (Actual): April 8, 2017
• Study Completion (Actual): June 8, 2017

Study Registration Dates

• First Submitted: October 10, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: hyperbaric oxygen; high intensity interval training
• Other Study ID Numbers: 1050188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No