Clinical trial NCT05984186: Effect of High Velocity/Hyperoxic Breathing Therapy on Blood Lactate Decline
Official title: Wingate-type Exercise Test to Evaluate the Effect of High Velocity Therapy on Recovery Sensation and Blood Lactate Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Lactic Acidosis
Muscle
Breathlessness
Exercise
Recovery
Lead sponsor: Vapotherm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Auburn University
First posted: 2023-08-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Lactate Change
timeFrame: 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).
Secondary outcomes:
measure: Respiratory Rate Change
timeFrame: 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.
measure: Heart Rate Change
timeFrame: 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.
measure: SpO2 Change
timeFrame: 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.
measure: Systolic Blood Pressure Change
timeFrame: 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.
measure: Diastolic Blood Pressure Change
timeFrame: 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.
measure: Perceived Level of Exertion Change
timeFrame: 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.
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: Bruce Gladden
role: PRINCIPAL_INVESTIGATOR
affiliation: Auburn University
name: Michael Roberts
role: PRINCIPAL_INVESTIGATOR
affiliation: Auburn University
name: Max Michael
role: PRINCIPAL_INVESTIGATOR
affiliation: Auburn University
name: Nina Stute
role: PRINCIPAL_INVESTIGATOR
References: