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CompletedNCT05116397Updated May 31, 2022

Influence of Graded Hypercapnia on Endurance Exercise Performance

An interventional study of Inspired gas in Hypercapnia, sponsored by United States Army Research Institute of Environmental Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-31.

Sponsored by United States Army Research Institute of Environmental Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypercapnia

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03

In context

Hypercapnia

186 studies on the registry are indexed under Hypercapnia; 34 are open to participants now.

This study's enrollment of 15 is below the median of 49 across 140 interventional studies indexed under Hypercapnia.

Browse Hypercapnia studies →

Lead sponsor

United States Army Research Institute of Environmental Medicine is the lead sponsor of 67 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    4% CO2

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

    Other: Inspired gas

  • Experimental
    2% CO2

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

    Other: Inspired gas

  • Sham comparator
    0% CO2

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

    Other: Inspired gas

Interventions

  • OtherInspired gas

    Inspired gas content

06

What researchers measure

Primary outcomes

  1. 2 mile self-paced treadmill time trial performance

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

    Time frame: 30 minutes

Secondary outcomes

  1. Ventilation rate

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

    Time frame: 30 minutes

  2. Oxygen consumption

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

    Time frame: 30 minutes

  3. Heart rate

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

    Time frame: 30 minutes

  4. Arterialized capillary pH

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

    Time frame: 30 minutes

  5. Arterialized capillary pCO2

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

    Time frame: 30 minutes

  6. Arterialized capillary HCO3

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

    Time frame: 30 minutes

  7. Rating of perceived exertion

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

    Time frame: 30 minutes

  8. Dyspnea

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

    Time frame: 30 minutes

  9. Leg discomfort

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

    Time frame: 30 minutes

  10. Headache

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

    Time frame: 30 minutes

  11. Breathing descriptors

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

    Time frame: 30 minutes

07

Study locations

1 site
  • USARIEM
    Natick, Massachusetts 01760, United States
08

References and documents

Study documents

  • Informed consent form · Sep 10, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05116397
Lead sponsor
United States Army Research Institute of Environmental Medicine
Responsible party
Sponsor
First posted
Nov 11, 2021
Start date
Sep 10, 2021
Primary completion
Apr 14, 2022
Completion
Apr 14, 2022
Last update
May 31, 2022

Study contacts

Benjamin J Ryan, Ph.D.
principal investigator · United States Army Research Institute of Environmental Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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