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

Vapotherm

Status: Completed

Conditions: Dyspnea; Muscle; Lactic Acidosis; Recovery; Exercise; Breathlessness

Treatments: Device: High Velocity Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05984186

RP-VTPF2022001Sci

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

FiO2=100% with Flow=5LPM

Experimental group

Description:

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.

Treatment:

Device: High Velocity Therapy

FiO2=21% with Flow=25-35LPM

Experimental group

Description:

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.

Treatment:

Device: High Velocity Therapy

FiO2=100% with Flow=25-35LPM

Experimental group

Description:

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.

Treatment:

Device: High Velocity Therapy

FiO2=21% with Flow=5LPM

Experimental group

Description:

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.

Treatment:

Device: High Velocity Therapy