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

• Sponsor: Vapotherm, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05984186
• Collaborator: Auburn University (Other)
• Enrollment: 15
• Location: 1
• Anticipated Duration (Months): 9.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dyspnea; Lactic Acidosis; Muscle; Breathlessness; Exercise; Recovery	Device: high velocity therapy

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Wingate-type Exercise Test to Evaluate the Effect of High Velocity Therapy on Recovery Sensation and Blood Lactate Decline
• Actual Study Start Date: Mar 6, 2023
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
low flow on room air	Device: high velocity therapy; 4 different flow settings and FIO2
low flow on oxygen	Device: high velocity therapy; 4 different flow settings and FIO2
high flow on room air	Device: high velocity therapy; 4 different flow settings and FIO2
high flow with oxygen	Device: high velocity therapy; 4 different flow settings and FIO2

Outcome Measures

Primary Outcome Measures

1. Blood lactate change [From exercise test through recovery period, 60 min]

   The change in blood lactate starting from the exercise test throughout the recovery period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Auburn University	Auburn	Alabama	United States	36849

Sponsors and Collaborators

• Vapotherm, Inc.
• Auburn University

Investigators

• Principal Investigator: Bruce Gladden, Auburn University
• Principal Investigator: Michael Roberts, Auburn University
• Principal Investigator: Max Michael, Auburn University
• Principal Investigator: Nina Stute, Auburn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vapotherm, Inc.
• ClinicalTrials.gov Identifier: NCT05984186
• Other Study ID Numbers: RP-VTPF2022001Sci
• First Posted: Aug 9, 2023
• Last Update Posted: Aug 9, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Dyspnea; Acidosis; Acidosis, Lactic

Study Results

No Results Posted as of Aug 9, 2023