NCT02941939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

October 10, 2016

Last Update Submit

May 18, 2018

Conditions

Keywords

high intensity interval traininghyperbaric oxygen

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in VO2 measured at anaerobic threshold (in mL O2/kg/min) at 2 weeks compared to baseline

    2 weeks

  • ΔVO2/ΔWR (in mL O2/kg/min/Watt; a measure of exercise efficiency)

    2 weeks

  • Change in peak work rate (in Watts) at 2 weeks compared to baseline

    2 weeks

  • Change in heart rate response to exercise at 2 weeks compared with baseline

    2 weeks

  • Change in level of perceived exertion at 2 weeks compared with baseline

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Ambient pressure arm

ACTIVE COMPARATOR

High intensity training will be completed while the subjects are breathing normal air.

Other: Ambient pressure

Hyperoxic-hyperbaric arm

EXPERIMENTAL

The high intensity training program will be carried out in a hyperbaric chamber.

Other: Hyperbaric chamber

Interventions

Hyperoxic-hyperbaric arm
Ambient pressure arm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Study Officials

  • Matt Hegewald, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 21, 2016

Study Start

April 14, 2016

Primary Completion

April 8, 2017

Study Completion

June 8, 2017

Last Updated

May 22, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations