Trial Outcomes & Findings for Hyperbaric VO2max Study (NCT NCT02356900)
NCT ID: NCT02356900
Last Updated: 2017-05-17
Results Overview
Graded exercise test to exhaustion at simulated 15000 ft altitude
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline and <72 hrs Post-training
Results posted on
2017-05-17
Participant Flow
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completed the study, 1 was a screen failure, 1 withdrew after the initial biopsy and rash from bandage adhesive, 1 was withdrawn due to schedule noncompliance, and one was withdrawn after a syncopal episode during the initial biopsy.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hyperbaric VO2max Study
Baseline characteristics by cohort
| Measure |
Hyperoxic, Hyperbaric
n=11 Participants
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
|
Normoxic, Normobaric
n=10 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.0 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
25.9 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
25.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and <72 hrs Post-trainingPopulation: 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.
Graded exercise test to exhaustion at simulated 15000 ft altitude
Outcome measures
| Measure |
Hyperoxic, Hyperbaric
n=8 Participants
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
|
Normoxic, Normobaric
n=9 Participants
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.
|
|---|---|---|
|
Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )
|
3.8 mL/kg/min
Standard Deviation 5.0
|
4.2 mL/kg/min
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Baseline and <72 hrs Post-trainingPopulation: 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.
Graded exercise test to exhaustion at simulated 15000 ft altitude
Outcome measures
| Measure |
Hyperoxic, Hyperbaric
n=8 Participants
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
|
Normoxic, Normobaric
n=9 Participants
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.
|
|---|---|---|
|
Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)
|
3.2 mL/kg/min
Standard Deviation 4.9
|
2.3 mL/kg/min
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: Baseline/24 hrs Post-trainingPopulation: Muscle Biopsy samples were not analyzed due to funding issues.
Immunofluorescence microscopy using citrate synthase staining
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline/24 hrs Post-trainingPopulation: Muscle Biopsy samples were not analyzed due to funding issues.
Western analysis
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline/24 hrs Post-trainingPopulation: Muscle Biopsy samples were not analyzed due to funding issues.
Western analysis
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline/24 hrs Post-trainingPopulation: Muscle Biopsy samples were not analyzed due to funding issues.
Real-time PCR
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline/24 hrs Post-trainingPopulation: Muscle Biopsy samples were not analyzed due to funding issues.
Immunofluorescence microscopy using citrate synthase staining
Outcome measures
Outcome data not reported
Adverse Events
Hyperoxic, Hyperbaric
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normoxic, Normobaric
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hyperoxic, Hyperbaric
n=11 participants at risk
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
|
Normoxic, Normobaric
n=10 participants at risk
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.
|
|---|---|---|
|
General disorders
Dizziness
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place