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

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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.

Tracking Information
First Submitted Date  ICMJE October 10, 2016
First Posted Date  ICMJE October 21, 2016
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE April 14, 2016
Actual Primary Completion Date April 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
Change in maximum VO2 at 2 weeks compared to baseline [ Time Frame: 2 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
  • 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
  • ΔVO2/ΔWR (in mL O2/kg/min/Watt; a measure of exercise efficiency) [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training
  • Change in peak work rate (in Watts) at 2 weeks compared to baseline [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training
  • Change in heart rate response to exercise at 2 weeks compared with baseline [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training
  • Change in level of perceived exertion at 2 weeks compared with baseline [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training
  • Change in Borg dyspnea score at 2 weeks compared with baseline [ Time Frame: 2 weeks ]
    Difference post-training minus pre-training
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
  • Change in VO2 measured at anaerobic threshold (in mL O2/kg/min) at 2 weeks compared to baseline [ Time Frame: 2 weeks ]
  • ΔVO2/ΔWR (in mL O2/kg/min/Watt; a measure of exercise efficiency) [ Time Frame: 2 weeks ]
  • Change in peak work rate (in Watts) at 2 weeks compared to baseline [ Time Frame: 2 weeks ]
  • Change in heart rate response to exercise at 2 weeks compared with baseline [ Time Frame: 2 weeks ]
  • Change in level of perceived exertion at 2 weeks compared with baseline [ Time Frame: 2 weeks ]
  • Change in Borg dyspnea score at 2 weeks compared with baseline [ Time Frame: 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of High-Intensity Interval Training (HIT) While in a Hyperoxic-Hyperbaric Environment on Exercise Performance
Official Title  ICMJE Effects of High-Intensity Interval Training (HIT) While in a Hyperoxic-Hyperbaric Environment on Exercise Performance (HITOP Study)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Exercise Performance
Intervention  ICMJE
  • Other: Hyperbaric chamber
  • Other: Ambient pressure
Study Arms  ICMJE
  • Active Comparator: Ambient pressure arm
    High intensity training will be completed while the subjects are breathing normal air.
    Intervention: Other: Ambient pressure
  • Experimental: Hyperoxic-hyperbaric arm
    The high intensity training program will be carried out in a hyperbaric chamber.
    Intervention: Other: Hyperbaric chamber
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 8, 2017
Actual Primary Completion Date April 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02941939
Other Study ID Numbers  ICMJE 1050188
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Intermountain Health Care, Inc.
Study Sponsor  ICMJE Intermountain Health Care, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matt Hegewald, MD Intermountain Health Care, Inc.
PRS Account Intermountain Health Care, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP