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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02941939
Other study ID # 1050188
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 14, 2016
Est. completion date June 8, 2017

Study information

Verified date May 2018
Source Intermountain Health Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 8, 2017
Est. primary completion date April 8, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Hyperbaric chamber

Ambient pressure


Locations

Country Name City State
United States Intermountain Medical Center Murray Utah

Sponsors (1)

Lead Sponsor Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary ?VO2/?WR (in mL O2/kg/min/Watt; a measure of exercise efficiency) Difference post-training minus pre-training 2 weeks
Secondary Change in peak work rate (in Watts) at 2 weeks compared to baseline Difference post-training minus pre-training 2 weeks
Secondary Change in heart rate response to exercise at 2 weeks compared with baseline Difference post-training minus pre-training 2 weeks
Secondary Change in level of perceived exertion at 2 weeks compared with baseline Difference post-training minus pre-training 2 weeks
Secondary Change in Borg dyspnea score at 2 weeks compared with baseline Difference post-training minus pre-training 2 weeks
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