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

Not Applicable

Completed

Conditions: Breathlessness
Exercise
Muscle
Recovery
Dyspnea
Lactic Acidosis

Interventions: Device: High Velocity Therapy

Registration Number: NCT05984186

Lead Sponsor: Vapotherm, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FiO2=100% with Flow=5LPM	High Velocity Therapy	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.
FiO2=21% with Flow=25-35LPM	High Velocity Therapy	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.
FiO2=100% with Flow=25-35LPM	High Velocity Therapy	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.
FiO2=21% with Flow=5LPM	High Velocity Therapy	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.

Primary Outcome Measures

Name	Time	Method
Blood Lactate Change	At rest (TR) and during recovery from the Wingate test at minute 2 (T2) minute 4 (T4), minute 6 (T6), minute 8 (T8), minute 10 (T10) minute 15 (T15), minute 20 (T20), minute 25 (T25), minute 30 (T30) minute 40 (T40), minute 50 (T50) minute 60 (T60).	The change in blood lactate starting from the exercise test throughout the recovery period

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate Change	Prior to the Wingate test (TR) and after at 1min (T1), 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.	The change in respiratory rate starting from the exercise test throughout the recovery period
Heart Rate Change	Prior to the Wingate test (TR) and after 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.	The change in heart rate starting from the exercise test throughout the recovery period
SpO2 Change	Prior to the Wingate test (TR) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.	The change in SpO2 starting from the exercise test throughout the recovery period.
Systolic Blood Pressure Change	Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.	The change in systolic blood pressure starting from the exercise test throughout the recovery period.
Diastolic Blood Pressure Change	Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.	The change in diastolic blood pressure change starting from the exercise test throughout the recovery period.
Perceived Level of Exertion Change	Immediately after the Wingate test (T0) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.	The change in the subjects perceived level of exertion starting from after the exercise test throughout the recovery period. The scale will be 0-10; a lower score is a lower level of exhaustion, a higher score is a higher level of exhaustion.