HBOT and Exercise Recovery

NCT ID: NCT05924035

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2023-08-31

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.

Conditions

Exercise Recovery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: EXPERIMENTAL

HBOT

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Gardner, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000035148

Identifier Type: -

Identifier Source: org_study_id