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Completed

NCT Number: NCT05116397

Influence of Graded Hypercapnia on Endurance Exercise Performance

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USARIEM

Natick, Massachusetts, 01760, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspired gas

Other

Inspired gas content

Primary outcomes

  1. 2 mile self-paced treadmill time trial performance

    Time frame: 30 minutes

    Time to complete self-paced 2 mile treadmill time trial (min:sec)

Secondary outcomes

  1. Ventilation rate

    Time frame: 30 minutes

    Ventilation rate will be assessed using a pneumotachometer [L/min]

  2. Oxygen consumption

    Time frame: 30 minutes

    Oxygen consumption will be assessed using computerized indirect calorimetry [ml/kg/min]

  3. Heart rate

    Time frame: 30 minutes

    Heart rate will be assessed using telemetry [beats per min]

  4. Arterialized capillary pH

    Time frame: 30 minutes

    Arterialized capillary pH will be assessed using a blood gas analyzer [Unitless]

  5. Arterialized capillary pCO2

    Time frame: 30 minutes

    Arterialized capillary pCO2 will be assessed using a blood gas analyzer [mmHg]

  6. Arterialized capillary HCO3

    Time frame: 30 minutes

    Arterialized capillary HCO3 will be assessed using a blood gas analyzer [mEq/L]

  7. Rating of perceived exertion

    Time frame: 30 minutes

    Rating of perceived exertion will be assessed using Borg's 6-20 scale [AU]

  8. Dyspnea

    Time frame: 30 minutes

    Rating of perceived dyspnea will be assessed using Borg's 0-10 scale [AU]

  9. Leg discomfort

    Time frame: 30 minutes

    Rating of perceived leg discomfort will be assessed using Borg's 0-10 scale [AU]

  10. Headache

    Time frame: 30 minutes

    Headache will be assessed using a visual analog scale [AU]

  11. Breathing descriptors

    Time frame: 30 minutes

    Breathing descriptors will be assessed by having participants check statements that apply to their breathing (e.g., breathing out requires more effort) [unitless]

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 11, 2021
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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