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N/A N=15 Randomized Other

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

Dyspnea · Lactic Acidosis · Muscle · Breathlessness · Exercise

Bottom Line

View on ClinicalTrials.gov: NCT05984186 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Blood Lactate Change — 1.19; 1.22; 1.11; 1.05 mmol/L

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
High Velocity Therapy (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Vapotherm, Inc.
Primary completion
Jul 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Blood Lactate Change		 1.19; 1.22; 1.11; 1.05; 9.85; 9.63 —
SECONDARY
Respiratory Rate Change		 14.04; 14.35; 15.24; 13.59; 29.01; 25.05 —
SECONDARY
Heart Rate Change		 78.7; 77.43; 77.33; 81.13; 121.60; 120.53 —
SECONDARY
SpO2 Change		 99.07; 98.71; 98.13; 98.49; 98.20; 98.13 —
SECONDARY
Systolic Blood Pressure Change		 125.73; 126.27; 125.20; 121.33; 132.87; 138.57 —
SECONDARY
Diastolic Blood Pressure Change		 75.73; 76.73; 75.53; 75.00; 67.20; 69.14 —
SECONDARY
Perceived Level of Exertion Change		 8.40; 7.86; 8.54; 8.93; 7.07; 6.87 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05984186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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