Influence of Graded Hypercapnia on Endurance Exercise Performance

Sponsor
United States Army Research Institute of Environmental Medicine (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT05116397
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Inspired gas
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized, single-blinded crossover designRandomized, single-blinded crossover design
Masking:
Single (Participant)
Masking Description:
Single-blinded
Primary Purpose:
Other
Official Title:
Influence of Graded Hypercapnia on Endurance Exercise Performance
Actual Study Start Date :
Sep 10, 2021
Actual Primary Completion Date :
Apr 14, 2022
Actual Study Completion Date :
Apr 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 4% CO2

Inspired gas containing 4% CO2, 21% O2, balance N2

Other: Inspired gas
Inspired gas content

Experimental: 2% CO2

Inspired gas containing 2% CO2, 21% O2, balance N2

Other: Inspired gas
Inspired gas content

Sham Comparator: 0% CO2

Inspired gas containing 0% CO2, 21% O2, balance N2

Other: Inspired gas
Inspired gas content

Outcome Measures

Primary Outcome Measures

  1. 2 mile self-paced treadmill time trial performance [30 minutes]

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

Secondary Outcome Measures

  1. Ventilation rate [30 minutes]

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

  2. Oxygen consumption [30 minutes]

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

  3. Heart rate [30 minutes]

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

  4. Arterialized capillary pH [30 minutes]

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

  5. Arterialized capillary pCO2 [30 minutes]

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

  6. Arterialized capillary HCO3 [30 minutes]

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

  7. Rating of perceived exertion [30 minutes]

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

  8. Dyspnea [30 minutes]

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

  9. Leg discomfort [30 minutes]

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

  10. Headache [30 minutes]

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

  11. Breathing descriptors [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 USARIEM Natick Massachusetts United States 01760

Sponsors and Collaborators

  • United States Army Research Institute of Environmental Medicine

Investigators

  • Principal Investigator: Benjamin J Ryan, Ph.D., United States Army Research Institute of Environmental Medicine

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT05116397
Other Study ID Numbers:
  • USARIEM
First Posted:
Nov 11, 2021
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022