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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05984186
• Other study ID #: RP-VTPF2022001Sci
• Status: Active, not recruiting
• Start date: March 6, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Vapotherm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Device:
• high velocity therapy
4 different flow settings and FIO2

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Vapotherm, Inc.	Auburn University

Country where clinical trial is conducted

United States, 

Outcome

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