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Lack of funding required to enroll target subject number
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperoxic hyperbaric interval exercise training | Procedure | Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours ) | Graded exercise test to exhaustion at simulated 15000 ft altitude | 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 | Baseline and <72 hrs Post-training |
| Mitochondrial Mass Change | Immunofluorescence microscopy using citrate synthase staining | Baseline/24 hrs Post-training |
| Tfam Muscle Protein Content Change | Western analysis | Baseline/24 hrs Post-training |
| Pgc-1a Coactivator Muscle Protein Content Change | Western analysis | Baseline/24 hrs Post-training |
| COX-I Gene Expression Change | Real-time PCR | Baseline/24 hrs Post-training |
| Muscle Phenotype Change | Immunofluorescence microscopy using citrate synthase staining | Baseline/24 hrs Post-training |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36060678 | Derived | 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. |
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25 participants were consented. 21 were randomized and completed the study, 1 was a screen failure, 1 withdrew after the initial biopsy and rash from bandage adhesive, 1 was withdrawn due to schedule noncompliance, and one was withdrawn after a syncopal episode during the initial biopsy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyperoxic, Hyperbaric | 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. Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber. Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention |
| FG001 | Normoxic, Normobaric | Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis. Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperoxic, Hyperbaric | 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. Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber. Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours ) | Graded exercise test to exhaustion at simulated 15000 ft altitude | 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. | Posted | Mean | Standard Deviation | mL/kg/min | Baseline and <72 hrs Post-training |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyperoxic, Hyperbaric | 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. Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber. Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment | Dizziness resulting from hypoxemia due to exposure to high altitude, 15,000'. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Moon, MD | Duke University Medical School | 919-684-6726 | richard.moon@duke.edu |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Normoxic, normobaric, interval exercise training | Procedure | Six 30-min high-intensity interval training sessions completed 3-times a week. |
|
| Oxygen | Drug | Used in Hyperoxic hyperbaric interval exercise training intervention |
|
| BG001 | Normoxic, Normobaric | Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis. Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Normoxic, Normobaric | Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis. Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week. |
|
|
| Primary | Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours) | Graded exercise test to exhaustion at simulated 15000 ft altitude | 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. | Posted | Mean | Standard Deviation | mL/kg/min | Baseline and <72 hrs Post-training |
|
|
|
| Primary | Mitochondrial Mass Change | Immunofluorescence microscopy using citrate synthase staining | Muscle Biopsy samples were not analyzed due to funding issues. | Posted | Baseline/24 hrs Post-training |
|
|
| Primary | Tfam Muscle Protein Content Change | Western analysis | Muscle Biopsy samples were not analyzed due to funding issues. | Posted | Baseline/24 hrs Post-training |
|
|
| Primary | Pgc-1a Coactivator Muscle Protein Content Change | Western analysis | Muscle Biopsy samples were not analyzed due to funding issues. | Posted | Baseline/24 hrs Post-training |
|
|
| Primary | COX-I Gene Expression Change | Real-time PCR | Muscle Biopsy samples were not analyzed due to funding issues. | Posted | Baseline/24 hrs Post-training |
|
|
| Primary | Muscle Phenotype Change | Immunofluorescence microscopy using citrate synthase staining | Muscle Biopsy samples were not analyzed due to funding issues. | Posted | Baseline/24 hrs Post-training |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Normoxic, Normobaric | Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis. Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week. | 0 | 10 | 0 | 10 | 1 | 10 |
|
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