Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03525561
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2018-03-16
Brief Title:
Acetazolamide and Exercise Performance at Altitude
Sponsor:
United States Army Research Institute of Environmental Medicine
Organization:
United States Army Research Institute of Environmental Medicine
Study Overview
Official Title:
Influences of Acetazolamide on Endurance Exercise Performance and Cognitive Function During Acute Exposure to Hypobaric Hypoxia
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goals of the present study are to evaluate whether the most common and effective treatment for acute mountain sickness AMS acetazolamide AZ has a negative positive or no influence on exercise performance cognitive performance or manual dexterity in young healthy subjects during simulated altitude exposure AMS represents a serious challenge to the health and performance of the Warfighter who may need to rapidly deploy to high altitude However there have been concerns that AZ might alter or impair endurance exercise performance and possibly fine motor skills These would represent major limitations to the use of this drug in a Warfighter who has a specific timeframe in which to accomplish mission tasks In the present project we will use exposure to simulated altitude in the USARIEM hypobaric chamber to quantify the impact if any of AZ on endurance exercise performance following rapid ascent to 3500 meters m in unacclimatized lowlander volunteers The study will be conducted using a randomized single-blind placebo-controlled crossover study design Ten male and female volunteers will complete one orientation day one VO2peak day three days of familiarization testing at sea level SL then two rounds of experimental testing Each round of experimental testing consists of six days including four days to establish baseline euhydration followed by a 30 hour hr exposure to 3500 m Volunteers will have a two week break between experimental testing rounds for washout of any effects of altitude acclimation During one experimental round volunteers will take two doses of AZ each day Phase 1 250 mgdose500 mgday Phase 2 125 mgdose 250 mgday starting 48 hr prior to their altitude exposure and continuing for the 30 hr stay at high altitude During the other experimental condition volunteers will be given a placebo at the same time points as the doses of AZ Prior to altitude exposure AMS will be evaluated and volunteers will then ascend to a simulated altitude of 3500 m where they will remain for 30 hr Volunteers will rest at altitude for an hr after which they will complete an AMS questionnaire resting ventilation measurements provide a blood sample and complete cognitive and finger dexterity testing Subjects will then perform 15 minutes min of steady state SS treadmill exercise at 40-45 of SL VO2peak and a 2 mile treadmill time trial TT Volunteers will stay overnight in the hypobaric chamber with research staff supervision The following morning metabolic and blood measurements will again be completed after which volunteers will perform the exercise testing for a second time Cognitive and finger dexterity testing will be performed before volunteers return to sea level ie descend from the simulated altitude The results of the proposed study will for the first time provide quantitative evidence regarding whether AZ treatment impairs endurance exercise performance in the context of a Warfighter-relevant endurance exercise task
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None