Effect of High Velocity/Hyperoxic Breathing Therapy on Blood Lactate Decline

NCT ID: NCT05984186

Last Updated: 2024-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2023-12-31

Brief Summary

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The study will evaluate the impact of high velocity therapy (HVT) on reduction of work of breathing (as implied by breath frequency) and enhanced blood lactate decline during recovery from a Wingate-type Exercise test. The study will include four study segments, corresponding to four different therapy settings.

Detailed Description

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HVT has been found to be a useful clinical tool for treatment of Type 1 and Type 2 respiratory failure (including hypercapnic respiratory failure), acute decompensated heart failure, and COVID respiratory complications. The overall objective of this prospective, pilot study is to evaluate whether HVT might enhance the decline of blood lactate concentrations following a high intensity exercise bout, in healthy volunteers. The hypothesis is that HVT, regardless of the oxygen concentration (i.e., FiO2), will reduce the work of breathing and increase the lactate clearance rate during exercise and recovery intervals. This pilot study could ignite further research providing HVT applications to high performing athletics and patients in an acute care setting requiring physical rehabilitation.

Conditions

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Dyspnea Lactic Acidosis Muscle Breathlessness Exercise Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FiO2=100% with Flow=5LPM

The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset.

The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery.

Group Type EXPERIMENTAL

High Velocity Therapy

Intervention Type DEVICE

FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM

FiO2=21% with Flow=25-35LPM

The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset.

The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery.

Group Type EXPERIMENTAL

High Velocity Therapy

Intervention Type DEVICE

FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM

FiO2=100% with Flow=25-35LPM

The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset.

The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery.

Group Type EXPERIMENTAL

High Velocity Therapy

Intervention Type DEVICE

FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM

FiO2=21% with Flow=5LPM

The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset.

The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery.

Group Type EXPERIMENTAL

High Velocity Therapy

Intervention Type DEVICE

FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM

Interventions

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High Velocity Therapy

FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults18-30 years old, in a general state of good health, of either sex
* No known contraindication to performing a maximal exercise test, i.e., Wingate-type Anaerobic exercise test
* Participants must consider themselves able to perform "regular moderate" or "regular strenuous" exercise.
* ° "Regular moderate" exercise includes less than 30 minutes every day or 30 minutes every other day, of some form of deliberate exercise, that does not include walking.
* ° "Regular strenuous" exercise is 30+ minutes per day, of some form of deliberate exercise, that does not include walking.

Exclusion Criteria

* Not considered a 'high-performance athlete'
* Known active cardiovascular, metabolic, liver, or renal disease
* Orthopedic limitations to exercise
* Pregnancy
* Use of beta-blockers or beta-agonist asthma medications
* Exercise induced asthma
* Any other health-related issue that would involve the participant's fitness capability
* Inability to complete all of the study procedures
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Auburn University

OTHER

Sponsor Role collaborator

Vapotherm, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Gladden

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Michael Roberts

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Max Michael

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Nina Stute

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Locations

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Auburn University

Auburn, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RP-VTPF2022001Sci

Identifier Type: -

Identifier Source: org_study_id

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