Exercise PerformanceHITOPNCT02941939
Effects of High-Intensity Interval Training (HIT) While in a Hyperoxic-Hyperbaric Environment on Exercise Performance
A study testing Hyperbaric chamber and Ambient pressure in people with Exercise Performance, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- Hyperbaric chamber and Ambient pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2016to 8 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise Performance
- Being tested
- Hyperbaric chamber, Ambient pressure
- Keywords
- high intensity interval training, hyperbaric oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric chamberOther
Ambient pressureOther
| Study group | Role | What they receive |
|---|---|---|
| Ambient pressure arm | Active comparator | High intensity training will be completed while the subjects are breathing normal air. Receives: Other: Ambient pressure |
| Hyperoxic-hyperbaric arm | Experimental | The high intensity training program will be carried out in a hyperbaric chamber. Receives: Other: Hyperbaric chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (6)
Change in VO2 measured at anaerobic threshold (in mL O2/kg/min) at 2 weeks compared to baseline
Difference post-training minus pre-training
Measured: 2 weeks
ΔVO2/ΔWR (in mL O2/kg/min/Watt; a measure of exercise efficiency)
Difference post-training minus pre-training
Measured: 2 weeks
Change in peak work rate (in Watts) at 2 weeks compared to baseline
Difference post-training minus pre-training
Measured: 2 weeks
Change in heart rate response to exercise at 2 weeks compared with baseline
Difference post-training minus pre-training
Measured: 2 weeks
Change in level of perceived exertion at 2 weeks compared with baseline
Difference post-training minus pre-training
Measured: 2 weeks
Change in Borg dyspnea score at 2 weeks compared with baseline
Difference post-training minus pre-training
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start14 Apr 2016
- Primary completion8 Apr 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matt Hegewald, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941939
- Sponsor's protocol ID
- 1050188
- Acronym
- HITOP
- Status last verified
- May 2018
- First submitted
- 10 Oct 2016
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Interval Training (HIT) While in a Hyperoxic-Hyperbaric Environment on Exercise Performance (HITOP Study)
- ClinicalTrials.gov ID
- NCT02941939
- Acronym / sponsor ID
- HITOP / 1050188
- Conditions
- Exercise Performance
- Keywords
- high intensity interval training, hyperbaric oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 8 Apr 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambient pressure arm | Active comparator | Other: Ambient pressureHigh intensity training will be completed while the subjects are breathing normal air. |
| Hyperoxic-hyperbaric arm | Experimental | Other: Hyperbaric chamberThe high intensity training program will be carried out in a hyperbaric chamber. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric chamber | Other | Hyperoxic-hyperbaric arm |
| Ambient pressure | Other | Ambient pressure arm |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Hegewald, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric chamber and Ambient pressure in people with Exercise Performance, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum VO2 at 2 weeks compared to baseline (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.