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Completed

NCT Number: NCT04679402

Diaphragm Function and Diver Endurance

This project will test the following hypotheses:

1. Training of the inspiratory muscles increases underwater endurance and reduces hypercapnia in divers. 2. Inspiratory muscle training while breathing low concentration carbon monoxide (200 ppm) for 30 minutes daily improves diaphragm performance to a greater degree than the same training breathing air. 3. Inspiratory muscle training increases hypercapnia ventilatory response (gain) in those individuals with a low gain. 4. Variability in oxygen (O2) and carbon dioxide (CO2) permeability of erythrocyte membranes is a determining factor in underwater exercise performance.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

The aims of this project are to: (1) test a method that could increase personal endurance and reduce excessive rise in blood carbon dioxide during underwater exercise in divers; and (2) understand the mechanisms by which red blood cells transport oxygen and carbon dioxide and their possible effects on exercise capacity. During underwater exercise, personal endurance capacity and elevated blood PCO2 are key parameters that affect a diver's safety and performance. Unlike exercise on dry land, hypercapnia often occurs during dives and can impair cognitive function and predispose the diver to central nervous system (CNS) oxygen toxicity and convulsions underwater. Some people intrinsically have low ventilatory chemosensitivity, and are more likely to develop hypercapnia during a dive. Lack of stamina may also be a mission-critical variable, and both endurance and the ability to control blood carbon dioxide depend on the respiratory muscle (mainly diaphragm) function, for which endurance capacity is related to mitochondrial number. Previous studies from our lab have demonstrated increased mitochondrial biogenesis with training while breathing a low, sub-toxic (200 ppm) level of carbon monoxide. In this study we will test the effect of daily respiratory muscle training with and without added carbon monoxide on respiratory muscle power, diaphragm thickness, respiratory muscle endurance and exercise endurance during a subsequent dive to 50 feet of sea water. Arterial PCO2 and lactic acid levels will be measured during exercise tests before and after training. Transport of O2 and CO2 through erythrocyte cell membranes occurs mostly through channels. Erythrocytes from volunteers in this study will be tested for O2 and CO2 permeability, and to correlate gas transport efficiency with exercise performance and blood PCO2.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Normal volunteers
  • Non-smokers
  • Range of hypercapnic ventilatory responses
  • VO2peak ≥35 mL.kg-1.min-1 (males)
  • ≥30 mL.kg-1.min-1 (females)

Exclusion criteria

  • Pregnancy
  • Cardiorespiratory disease, including hypertension
  • Neuromuscular disease
  • Anemia
  • Hemoglobinopathy, including sickle cell disease and trait

Treatment and study plan

Carbon monoxide 200 ppm in air

Other

Low dose carbon monoxide

Primary outcomes

  1. Underwater endurance change

    Time frame: Baseline, 6 weeks

    Endurance during continuous underwater exercise at a depth of 50 ft below the surface

  2. Arterial PCO2 change

    Time frame: Baseline, 6 weeks

    Blood gases during and at end of exercise

  3. Ventilatory chemosensitivity change

    Time frame: Baseline, 6 weeks

    Hypercapnic ventilatory response (VE.min-1.mmHg)

Secondary outcomes

  1. Erythrocyte gas channel analysis

    Time frame: Baseline

    Stopped-flow analysis of O2 offloading from Hb of (a) intact RBCs, (b) Hb in hemolysate

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Case Western Reserve University

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2020
Registry last updated
Jun 13, 2024

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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