Influence of Graded Hypercapnia on Endurance Exercise Performance

NCT ID: NCT05116397

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-04-14

Brief Summary

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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

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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.

Conditions

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Hypercapnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, single-blinded crossover design
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Single-blinded

Study Groups

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4% CO2

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

Group Type EXPERIMENTAL

Inspired gas

Intervention Type OTHER

Inspired gas content

2% CO2

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

Group Type EXPERIMENTAL

Inspired gas

Intervention Type OTHER

Inspired gas content

0% CO2

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

Group Type SHAM_COMPARATOR

Inspired gas

Intervention Type OTHER

Inspired gas content

Interventions

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Inspired gas

Inspired gas content

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin J Ryan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

United States Army Research Institute of Environmental Medicine

Locations

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USARIEM

Natick, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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USARIEM

Identifier Type: -

Identifier Source: org_study_id

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