HBOT and Exercise Recovery

Effect of Hyperbaric Oxygen Treatment (HBOT) on Recovery From Exercise

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.

Study Overview

• Status: Withdrawn
• Conditions: Exercise Recovery
• Intervention / Treatment: Device: HBOT

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Control Group will participate in standardized, prescribed exercise 4 days per week and perform countermovement jumps on a force plate both before and after daily workouts (standard of care summer athletic training)
Experimental: HBOT Treatment; HBOT Treatment Group will receive HBOT Treatment in addition to standardized, prescribed exercise 4 days per week and perform countermovement jumps on a force plate both before and after daily workouts (standard of care summer athletic training)	Device: HBOT; HBOT treatment on a multiplace chamber (OXYHeal Hyperbaric Oxygen Chamber), 100% oxygen at 2.0 atmospheres for 90 minutes - on 4 consecutive days within 3 hours of completion of exercise training (as soon as practically possible). This will occur during week 2 of data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Peak Propulsive Power	Relative Peak Propulsive Power will be assessed as the peak instantaneous mechanical power applied to the system center of mass during the population phase relative to the system mass from a countermovement jump using the Hawkin Dynamic force plates.	within 3 hours of exercise completion during week 2
modified Relative Strength Index (mRSI)	mRSI assessed as jump height calculated using the vertical velocity of the system center of mass at the instant of take-off divided by the total time taken from the initiation of movement to the instant of take-off using the Hawkin Dynamic force plates.	within 3 hours of exercise completion during week 2
Average Landing Force	Average Landing Force assessed as the average vertical ground reaction force applied to the system center of mass during the landing phase using the Hawkin Dynamic force plates.	within 3 hours of exercise completion during week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle oxygenation	Muscle oxygenation will be measured during and post exercise, with and without HBOT using a surface muscle oxygenation monitor on their vastus lateralis.	baseline and week 2
Change in Blood lactate	Blood lactate will be measured pre- and post-exercises, and post-HBOT using The Edge blood lactate monitoring system. 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.	baseline and week 2
Rate of Perceived Exertion (RPE) scale	The scale allows participants to subjectively rate their perceived level of exertion during exercise. It is scored from 0 (Nothing at all) to 11 (very, very hard) and reported using self-report. A higher score indicates more perceived exertion.	daily up to 3 weeks
Rate of Perceived Recovery (RPR) scale	The scale allows participants to subjectively rate their perceived level of recovery from last exercise session. It is scored from 0 (very poor recovery/extremely tired) to 11 (very good recovery/extremely well-disposed) and reported using self-report. A higher score indicates more perceived recovery.	daily up to 3 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Elizabeth Gardner, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Exercise Recovery; Hyperbaric Oxygen Treatment; High Performance Athletes
• Other Study ID Numbers: 2000035148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• 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.: No