Exercise TrainingPhase 2NCT02356900

Hyperbaric VO2max Study

A Phase 2 study testing Hyperoxic hyperbaric interval exercise training, Normoxic, normobaric, interval exercise training and Oxygen in people with Exercise Training, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Exercise Training
What is being tested?: Hyperoxic hyperbaric interval exercise training, Normoxic, normobaric, interval exercise training and Oxygen
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Feb 2015to May 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

healthy, recreationally active or sedentary individuals

Who cannot join

VO2max < 35 ml/kg/min - male 30 ml/kg/min - female
chronic cardiovascular or pulmonary diseases
history of pneumothorax
active smoker
pregnant women
non-english speaking

Show all 9Show fewer

not in full mental capacity
blind
sickle cell trait or disease

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Hospital
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Effects of High Intensity Interval Training in a Hyperoxic-hyperbaric Environment on Exercise Performance at Altitude

This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric environment for exercise performance at altitude. Subjects will complete a short, high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and after this training phase, all subjects will be tested for maximum aerobic capacity at a simulated high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers of mitochondrial oxidative capacity in a skeletal muscle biopsy.

A group of individuals of similar characteristics completing this training program in a normoxic-normobaric environment will serve as a control.

Conditions: Exercise Training
Being tested: Hyperoxic hyperbaric interval exercise training, Normoxic, normobaric, interval exercise training, Oxygen
Keywords: interval training, hyperbaric oxygen, VO2 max, altitude, exercise performance, mitochondrial oxidative capacity, mitochondrial biogenesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyperoxic hyperbaric interval exercise trainingProcedure or surgery
Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Normoxic, normobaric, interval exercise trainingProcedure or surgery
Six 30-min high-intensity interval training sessions completed 3-times a week.
OxygenDrug
Used in Hyperoxic hyperbaric interval exercise training intervention

Study groups in NCT02356900
Study group	Role	What they receive
Hyperoxic, Hyperbaric	Experimental	Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber. Receives: Procedure: Hyperoxic hyperbaric interval exercise training; Drug: Oxygen
Normoxic, Normobaric	Sham comparator	Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis. Receives: Procedure: Normoxic, normobaric, interval exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )
Graded exercise test to exhaustion at simulated 15000 ft altitude
Measured: Baseline and <72 hrs Post-training
Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)
Graded exercise test to exhaustion at simulated 15000 ft altitude
Measured: Baseline and <72 hrs Post-training
Mitochondrial Mass Change
Immunofluorescence microscopy using citrate synthase staining
Measured: Baseline/24 hrs Post-training
Tfam Muscle Protein Content Change
Western analysis
Measured: Baseline/24 hrs Post-training
Pgc-1a Coactivator Muscle Protein Content Change
Western analysis
Measured: Baseline/24 hrs Post-training
COX-I Gene Expression Change
Real-time PCR
Measured: Baseline/24 hrs Post-training
Muscle Phenotype Change
Immunofluorescence microscopy using citrate synthase staining
Measured: Baseline/24 hrs Post-training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015May 2016

First posted5 Feb 2015 (estimated)
Study startFeb 2015
Primary completionMay 2016
Study completionMay 2016

Why it stopped: Lack of funding required to enroll target subject number

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Exercise TrainingStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02356900
Sponsor's protocol ID: Pro00060147
Status last verified: Apr 2017
First submitted: 2 Feb 2015
Last updated: 17 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Alvarez Villela M, Dunworth SA, Kraft BD, Harlan NP, Natoli MJ, Suliman HB, Moon RE. Effects of high-intensity interval training with hyperbaric oxygen. Front Physiol. 2022 Aug 19;13:963799. doi: 10.3389/fphys.2022.963799. eCollection 2022.
PubMed 36060678

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Exercise Training trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of High Intensity Interval Training in a Hyperoxic-hyperbaric Environment on Exercise Performance at Altitude
ClinicalTrials.gov ID: NCT02356900
Acronym / sponsor ID: Pro00060147
Conditions: Exercise Training
Keywords: interval training, hyperbaric oxygen, VO2 max, altitude, exercise performance, mitochondrial oxidative capacity, mitochondrial biogenesis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of funding required to enroll target subject number
Enrolment: 25 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Feb 2015
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 5 Feb 2015 (estimated)
Results: Posted 12 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A group of individuals of similar characteristics completing this training program in a normoxic-normobaric environment will serve as a control.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Hyperoxic, Hyperbaric	Experimental	Procedure: Hyperoxic hyperbaric interval exercise training, Drug: OxygenHyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Normoxic, Normobaric	Sham comparator	Procedure: Normoxic, normobaric, interval exercise trainingNormoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

healthy, recreationally active or sedentary individuals

Key exclusion criteria (9 listed)

VO2max < 35 ml/kg/min - male 30 ml/kg/min - female
chronic cardiovascular or pulmonary diseases
history of pneumothorax
active smoker
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
Hyperoxic hyperbaric interval exercise trainingSix 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.	Procedure or surgery	Hyperoxic, Hyperbaric
Normoxic, normobaric, interval exercise trainingSix 30-min high-intensity interval training sessions completed 3-times a week.	Procedure or surgery	Normoxic, Normobaric
OxygenUsed in Hyperoxic hyperbaric interval exercise training intervention	Drug	Hyperoxic, Hyperbaric

Primary outcome

Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )
Time frame: Baseline and <72 hrs Post-training
Graded exercise test to exhaustion at simulated 15000 ft altitude
Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)
Time frame: Baseline and <72 hrs Post-training
Graded exercise test to exhaustion at simulated 15000 ft altitude
Mitochondrial Mass Change
Time frame: Baseline/24 hrs Post-training
Immunofluorescence microscopy using citrate synthase staining
Tfam Muscle Protein Content Change
Time frame: Baseline/24 hrs Post-training
Western analysis
Pgc-1a Coactivator Muscle Protein Content Change
Time frame: Baseline/24 hrs Post-training
Western analysis
COX-I Gene Expression Change
Time frame: Baseline/24 hrs Post-training
Real-time PCR
Muscle Phenotype Change
Time frame: Baseline/24 hrs Post-training
Immunofluorescence microscopy using citrate synthase staining

Results and safety

Results posted to the registry on 12 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hyperoxic, Hyperbaric	11	11
Normoxic, Normobaric	10	10

Primary outcome: Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )

Time frame: Baseline and <72 hrs Post-training. Mean (Standard Deviation). Unit: mL/kg/min

Measure	Hyperoxic, Hyperbaric n = 8	Normoxic, Normobaric n = 9
Value	3.8 (5.0)	4.2 (4.9)

Population analysed: Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.

Primary outcome: Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)

Time frame: Baseline and <72 hrs Post-training. Mean (Standard Deviation). Unit: mL/kg/min

Measure	Hyperoxic, Hyperbaric n = 8	Normoxic, Normobaric n = 9
Value	3.2 (4.9)	2.3 (3.4)

Population analysed: Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.

Primary outcome: Mitochondrial Mass Change

Time frame: Baseline/24 hrs Post-training

Population analysed: Muscle Biopsy samples were not analyzed due to funding issues.

Primary outcome: Tfam Muscle Protein Content Change

Time frame: Baseline/24 hrs Post-training

Population analysed: Muscle Biopsy samples were not analyzed due to funding issues.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hyperoxic, Hyperbaric	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Normoxic, Normobaric	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36060678Alvarez Villela M, Dunworth SA, Kraft BD, Harlan NP, Natoli MJ, Suliman HB, Moon RE. Effects of high-intensity interval training with hyperbaric oxygen. Front Physiol. 2022 Aug 19;13:963799. doi: 10.3389/fphys.2022.963799. eCollection 2022.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 May 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours ) (time frame: Baseline and <72 hrs Post-training). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02356900, which also lists 1 linked publication.

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 17 May 2017.