Clinical trial NCT05116397: Influence of Graded Hypercapnia on Endurance Exercise Performance
Official title: Influence of Graded Hypercapnia on Endurance Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnia
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
First posted: 2021-11-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, single-blinded crossover design
Primary purpose: OTHER

Brief summary: The aim of this randomized, single-blind, placebo-controlled crossover trial is to determine the effects of graded hypercapnia (0, 2, and 4% inspired CO2) on endurance performance. Twelve healthy and fit young adults (men and women) will complete this study. Participants will perform experimental trials on 3 separate days (one each breathing 0%, 2%, and 4% inspired CO2-all with normal 21% oxygen). During each trial, they will perform 10 minutes of submaximal treadmill walking exercise and then complete a self-paced 2-mile treadmill run time-trial.

Detailed description: Participants will undergo baseline measurements of pulmonary function and maximal oxygen uptake (VO2max). They will then complete two familiarization trials, with 10 minutes of submaximal exercise (\~40%VO2max) followed by a self-paced 2-mile treadmill time trial. Lastly, they will complete three experimental trials, repeating the same submaximal and time-trial exercise procedures while breathing the test gas (0%, 2%, or 4% CO2-all with normal 21% oxygen). During the experimental trials, arterialized capillary blood samples will be collected at rest breathing room air, at rest breathing the test gas, and during submaximal exercise at 40% VO2max breathing the test gas. The primary outcome is 2-mile treadmill time-trial performance. Secondary outcomes include ventilation, metabolic rate, heart rate, arterialized capillary pH/PCO2/HCO3, perceived exertion, dyspnea, leg discomfort, breathing descriptors, and headache ratings.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 18-45
* In good health as determined by medical screening
* Passed his/her most recent Army Combat Fitness Test (ACFT) (Military Volunteers Only) or performs aerobic exercise at least 2 times per week and able to complete two mile run in ≤ 21 minutes (Civilian Volunteers)
* Willing to not participate in any exercise or drink alcoholic beverages for 24 hours before each study visit.
* Willing to not take part in any strenuous exercise in the 36 hours before each visit.
* Willing not to drink caffeine or eat food until after testing on familiarization and performance testing visits (visits 2-6).
* Willing to maintain a similar dietary pattern in the 2 days before each familiarization and performance visits.
* Have supervisor approval if permanent party military or a federal employee at U.S. Army Natick Soldier System Center
* Able to speak and read English fluently

Exclusion Criteria:

* Females who are pregnant or planning to become pregnant during the study
* Taking dietary supplements, prescriptions, or over the counter medication, other than a contraceptive (unless approved by medical staff \& PI)
* Musculoskeletal injuries that compromise ability to run on a treadmill
* Abnormal blood count, presence of abnormal blood chemicals (hemoglobin S or sickle cell traits)
* Smokers or tobacco/nicotine users (unless have quit \> 1 month prior)
* Any history of asthma
* Current or recent respiratory tract or sinus infections (\< 1 month prior)
* Allergy to skin adhesive
* Any history of migraine or recurrent headaches
* Any history of panic disorder
* Blood donation in the previous 8 weeks
* Positive Covid-19 test within the last month

Primary outcomes:
measure: 2 mile self-paced treadmill time trial performance
timeFrame: 30 minutes
Secondary outcomes:
measure: Ventilation rate
timeFrame: 30 minutes
measure: Oxygen consumption
timeFrame: 30 minutes
measure: Heart rate
timeFrame: 30 minutes
measure: Arterialized capillary pH
timeFrame: 30 minutes
measure: Arterialized capillary pCO2
timeFrame: 30 minutes
measure: Arterialized capillary HCO3
timeFrame: 30 minutes
measure: Rating of perceived exertion
timeFrame: 30 minutes
measure: Dyspnea
timeFrame: 30 minutes
measure: Leg discomfort
timeFrame: 30 minutes
measure: Headache
timeFrame: 30 minutes
measure: Breathing descriptors
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Natick
country: United States
facility: USARIEM
state: Massachusetts
Study officials:
affiliation: United States Army Research Institute of Environmental Medicine
name: Benjamin J Ryan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: