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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Muscle, Dyspnea, Lactic Acidosis, Breathlessness, Exercise, Recovery

Intervention / Treatment
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* Device: high velocity therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females between the ages of 18-30 years, in a general state of good health 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 No heart or breathing condition No chest pain during activities of daily living of exercise No dizziness or loss of balance or consciousness during the previous 12 months Not a smoker No history of blood clots, known bleeding disorders, and must not be taking Coumadin or other blood thinners such as Brilinta, Effient, Eliquis, Plavix, Pradaxa, Savaysa, Xarelto, or an aspirin regimen Not diabetic Free of any medical condition that would contraindicate participating in intense exercise or donating a skeletal muscle biopsy (i.e. blood clotting disorder or taking blood thinners) Not allergic to Lidocaine or other caine anesthetics (for example, lignocaine, prilocaine, bupivacaine or others), or heparin No chronic medical condition that might cause exercise to be risky No bone, joint, or soft tissue problem that could be made worse by participation in the study Not allergic to latex or adhesives No restriction to comfortable breathing through the nose

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| low flow on room air<br> | Device: high velocity therapy<br>* 4 different flow settings and FIO2<br>|
| low flow on oxygen<br> | Device: high velocity therapy<br>* 4 different flow settings and FIO2<br>|
| high flow on room air<br> | Device: high velocity therapy<br>* 4 different flow settings and FIO2<br>|
| high flow with oxygen<br> | Device: high velocity therapy<br>* 4 different flow settings and FIO2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lactate change | The change in blood lactate starting from the exercise test throughout the recovery period | From exercise test through recovery period, 60 min |