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Completed

NCT Number: NCT05984186

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Velocity Therapy

Device

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

Primary outcomes

  1. Blood Lactate Change

    Time frame: 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 outcomes

  1. Respiratory Rate Change

    Time frame: 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

  2. Heart Rate Change

    Time frame: 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

  3. SpO2 Change

    Time frame: 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.

  4. Systolic Blood Pressure Change

    Time frame: 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.

  5. Diastolic Blood Pressure Change

    Time frame: 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.

  6. Perceived Level of Exertion Change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vapotherm, Inc.

Industry

Collaborators

  • Auburn University

Registry information

Official study title

Wingate-type Exercise Test to Evaluate the Effect of High Velocity Therapy on Recovery Sensation and Blood Lactate Decline

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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