Effect of High Velocity/Hyperoxic Breathing Therapy on Blood Lactate Decline
NCT ID: NCT05984186
Last Updated: 2024-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2023-03-06
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
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.
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
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.
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
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.
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
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.
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
30 Years
ALL
Yes
Sponsors
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Auburn University
OTHER
Vapotherm, Inc.
INDUSTRY
Responsible Party
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RP-VTPF2022001Sci
Identifier Type: -
Identifier Source: org_study_id
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