Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02941939
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Exercise Performance Other: Hyperbaric chamber Other: Ambient pressure Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of High-Intensity Interval Training (HIT) While in a Hyperoxic-Hyperbaric Environment on Exercise Performance (HITOP Study)
Actual Study Start Date : April 14, 2016
Actual Primary Completion Date : April 8, 2017
Actual Study Completion Date : June 8, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in maximum VO2 at 2 weeks compared to baseline [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in VO2 measured at anaerobic threshold (in mL O2/kg/min) at 2 weeks compared to baseline [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training

  2. ΔVO2/ΔWR (in mL O2/kg/min/Watt; a measure of exercise efficiency) [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training

  3. Change in peak work rate (in Watts) at 2 weeks compared to baseline [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training

  4. Change in heart rate response to exercise at 2 weeks compared with baseline [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training

  5. Change in level of perceived exertion at 2 weeks compared with baseline [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training

  6. Change in Borg dyspnea score at 2 weeks compared with baseline [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941939


Locations
Layout table for location information
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Matt Hegewald, MD Intermountain Health Care, Inc.
Layout table for additonal information
Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02941939    
Other Study ID Numbers: 1050188
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Intermountain Health Care, Inc.:
high intensity interval training
hyperbaric oxygen