Exercise Clinical Trial
Official title:
Wingate-type Exercise Test to Evaluate the Effect of High Velocity Therapy on Recovery Sensation and Blood Lactate Decline
Verified date | August 2023 |
Source | Vapotherm, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Auburn University | Auburn | Alabama |
Lead Sponsor | Collaborator |
---|---|
Vapotherm, Inc. | Auburn University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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