Trial Outcomes & Findings for Rapid Acclimatization to Hypoxia at Altitude (NCT NCT01702025)
NCT ID: NCT01702025
Last Updated: 2014-10-24
Results Overview
After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia
Results posted on
2014-10-24
Participant Flow
19 individual participants enrolled in the study. Participants were provided with the opportunity to re-enroll and enter additional arm(s).
Participant milestones
| Measure |
Placebo
Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
|
Aminophylline
Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
|
Methazolamide
Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
|
Aminophylline + Methazolamide
Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
|
Aminophylline
Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
|
Methazolamide
Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
|
Aminophylline + Methazolamide
Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
|
|---|---|---|---|---|
|
Overall Study
Equipment failure
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Rapid Acclimatization to Hypoxia at Altitude
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
|
Aminophylline
n=10 Participants
Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
|
Methazolamide
n=10 Participants
Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
|
Aminophylline + Methazolamide
n=10 Participants
Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 5 • n=5 Participants
|
26 years
STANDARD_DEVIATION 7 • n=7 Participants
|
27 years
STANDARD_DEVIATION 6 • n=5 Participants
|
27 years
STANDARD_DEVIATION 5 • n=4 Participants
|
27 years
STANDARD_DEVIATION 5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Body Mass Index
|
24.8 kg/m^2
STANDARD_DEVIATION 2 • n=5 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 2 • n=7 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 2 • n=5 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 2 • n=4 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 2 • n=21 Participants
|
|
Body Fat %
|
20.2 Percentage of body fat
STANDARD_DEVIATION 3 • n=5 Participants
|
21.4 Percentage of body fat
STANDARD_DEVIATION 7 • n=7 Participants
|
20.6 Percentage of body fat
STANDARD_DEVIATION 2 • n=5 Participants
|
22.4 Percentage of body fat
STANDARD_DEVIATION 7 • n=4 Participants
|
21.1 Percentage of body fat
STANDARD_DEVIATION 5 • n=21 Participants
|
|
Fat Mass
|
15.4 kilograms
STANDARD_DEVIATION 2 • n=5 Participants
|
16.5 kilograms
STANDARD_DEVIATION 5 • n=7 Participants
|
16.0 kilograms
STANDARD_DEVIATION 2 • n=5 Participants
|
17.4 kilograms
STANDARD_DEVIATION 5 • n=4 Participants
|
16.3 kilograms
STANDARD_DEVIATION 3 • n=21 Participants
|
|
Fat Free Mass
|
61.3 kilograms
STANDARD_DEVIATION 7 • n=5 Participants
|
60.8 kilograms
STANDARD_DEVIATION 8 • n=7 Participants
|
61.9 kilograms
STANDARD_DEVIATION 7 • n=5 Participants
|
60.9 kilograms
STANDARD_DEVIATION 9 • n=4 Participants
|
61.2 kilograms
STANDARD_DEVIATION 7 • n=21 Participants
|
|
maximal oxygen uptake (VO2max)
|
48.7 milliliter/kilogram/minute
STANDARD_DEVIATION 8 • n=5 Participants
|
49.4 milliliter/kilogram/minute
STANDARD_DEVIATION 10 • n=7 Participants
|
49.8 milliliter/kilogram/minute
STANDARD_DEVIATION 8 • n=5 Participants
|
46.5 milliliter/kilogram/minute
STANDARD_DEVIATION 8 • n=4 Participants
|
48.6 milliliter/kilogram/minute
STANDARD_DEVIATION 8 • n=21 Participants
|
PRIMARY outcome
Timeframe: The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxiaAfter exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.
Outcome measures
| Measure |
Normoxia Placebo
n=9 Participants
Placebo: single dose Normoxia
|
Hypoxia Placebo
n=9 Participants
Placebo: single dose hypoxia
|
Normoxia Aminophylline
n=9 Participants
Aminophylline:single dose Normoxia
|
Hypoxia Aminophylline
n=9 Participants
Aminophylline:single dose hypoxia
|
Normoxia Methazolamide
n=9 Participants
Methazolamide single dose Normoxia
|
Hypoxia Methazolamide
n=9 Participants
Methazolamide: single dose hypoxia
|
Normoxia Methazolamide/Aminophylline
n=10 Participants
Methazolamide combined with Aminophylline: single dose normoxia
|
Hypoxia Methazolamide/Aminophylline
n=10 Participants
Methazolamide combined with Aminophylline: single dose hypoxia
|
|---|---|---|---|---|---|---|---|---|
|
Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).
|
22.3 minutes
Standard Error 0.7
|
25.2 minutes
Standard Error 1.2
|
22.2 minutes
Standard Error 0.5
|
24.0 minutes
Standard Error 0.7
|
23.0 minutes
Standard Error 0.5
|
24.6 minutes
Standard Error 0.5
|
24.5 minutes
Standard Error 0.9
|
25.9 minutes
Standard Error 1.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Aminophylline
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Methazolamide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Aminophylline + Methazolamide
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=11 participants at risk
Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo Hypoxia
.
|
Aminophylline
n=10 participants at risk
Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
|
Methazolamide
n=10 participants at risk
Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide Hypoxia
|
Aminophylline + Methazolamide
n=10 participants at risk
Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
|
|---|---|---|---|---|
|
General disorders
Face Tingling
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/10
|
40.0%
4/10 • Number of events 4
|
|
General disorders
Double vision
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Lightheadedness
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
General disorders
Vasovagal
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Hypoglycemic event
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
|
General disorders
cardiac rhythm
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
Additional Information
Christopher Bell, Ph.D.
Department of Health and Exercise Science
Phone: (970) 491-7522
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place