Diaphragm Function and Diver Endurance

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04679402
Collaborator
Case Western Reserve University (Other)
60
1
2
22.5
2.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Carbon monoxide 200 ppm in air
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Mixed model with repeated measuresMixed model with repeated measures
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The only person who will know the breathing gas is the trial coordinator. Since carbon monoxide is a colorless, tasteless gas, the subject will be unaware of the group they are in. The gas labeling will be blinded.
Primary Purpose:
Basic Science
Official Title:
Diaphragm Function and Diver Endurance
Actual Study Start Date :
Apr 14, 2022
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Respiratory Muscle Training Breathing Low Dose Carbon Monoxide

Carbon monoxide 200 ppm in air breathing during daily 30 minute inspiratory loading training sessions. Subjects will breathe the experimental gas through a mouthpiece with nose-clip in place.

Other: Carbon monoxide 200 ppm in air
Low dose carbon monoxide

Sham Comparator: Respiratory Muscle Training Breathing Air

Air breathing during daily 30 minute inspiratory loading training sessions. Subjects will breathe air through a mouthpiece with nose-clip in place.

Other: Carbon monoxide 200 ppm in air
Low dose carbon monoxide

Outcome Measures

Primary Outcome Measures

  1. Underwater endurance change [Baseline, 6 weeks]

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

  2. Arterial PCO2 change [Baseline, 6 weeks]

    Blood gases during and at end of exercise

  3. Ventilatory chemosensitivity change [Baseline, 6 weeks]

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

Secondary Outcome Measures

  1. Erythrocyte gas channel analysis [Baseline]

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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University
  • Case Western Reserve University

Investigators

  • Principal Investigator: Richard E Moon, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04679402
Other Study ID Numbers:
  • Pro00107090
First Posted:
Dec 22, 2020
Last Update Posted:
Jun 1, 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
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022