Clinical trial NCT05924035: HBOT and Exercise Recovery
Official title: Effect of Hyperbaric Oxygen Treatment (HBOT) on Recovery From Exercise
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Exercise Recovery
Keywords: Hyperbaric Oxygen Treatment
Exercise Recovery
High Performance Athletes
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a prospective, case-controlled pilot study, performed over three weeks with 6 participants in each group.
Primary purpose: OTHER

Brief summary: The purpose of this pilot study is to investigate the effect of hyperbaric oxygen treatment on recovery from exercise in high performance athletes. Outcome measures will be both physical outcome measures from a force plate, as well as physiologic measures of recovery (including blood lactate and muscle oxygenation) and perceived rates of exertion and recovery.

Detailed description: Initial visit to discuss the study and obtain consent. At this visit, baseline subject demographics (height, weight, body composition) and a medical history will be taken to confirm that there are no medical contraindications to either exercise or HBOT. This visit will likely take 30-45 minutes.

There will be 15 subsequent visits. Each of these visits will be conducted concurrent with their standard off-season workouts. An additional 15 minutes per workout session may be required for the collection of study-related, non-standard of care, outcome measures.

During the second week of the study, the experimental group will have four daily 90 minute sessions of HBOT. Travel time from the site of their workouts (West Haven CT) to the HBOT facility (Bridgeport Hospital) is approximately 20 minutes.

Immediately following exercise, each experimental subject will be fitted with the surface muscle oxygenation monitor on their vastus lateralis. This monitor (Moxy, Fortiori Design LLC) utilizes near-infrared spectroscopy. The monitor will be applied to the distal third of the vastus lateralis muscle (12cm above the knee joint) as identified and marked by the PI (an orthopaedic surgeon). This will provide continuous muscle oxygenation report following exercise, including during and immediately after the HBOT treatment.

Both the experimental and control groups will have blood lactate measurements taken within 15 minutes before the start of their daily exercise, as well as within 5 minutes of the completion of exercise, utilizing The Edge blood lactate monitoring system (Apexbio, Taiwan). Once per week the performance of The Edge monitor will be validated utilizing The Edge Lactate Control Solution.

The Edge monitor measures blood lactate from a drop of blood from a finger tip applied to a sterile lancet. The result is reported in approximately 45 seconds.

Eligibility criteria: Inclusion Criteria:

* Yale University varsity student-athletes
* Cleared for unrestricted participation in varsity athletics training at the time of data collection
* No implantable electronic medical device (ie. Deep brain stimulator or insulin pump) or with other contraindication to HBOT
* Those who consent to participation

Primary outcomes:
measure: Relative Peak Propulsive Power
timeFrame: within 3 hours of exercise completion during week 2
measure: modified Relative Strength Index (mRSI)
timeFrame: within 3 hours of exercise completion during week 2
measure: Average Landing Force
timeFrame: within 3 hours of exercise completion during week 2
Secondary outcomes:
measure: Change in Muscle oxygenation
timeFrame: baseline and week 2
measure: Change in Blood lactate
timeFrame: baseline and week 2
measure: Rate of Perceived Exertion (RPE) scale
timeFrame: daily up to 3 weeks
measure: Rate of Perceived Recovery (RPR) scale
timeFrame: daily up to 3 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Elizabeth Gardner, MD
role: PRINCIPAL_INVESTIGATOR
References: