HBOT and Exercise Recovery

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05924035
Collaborator
(none)
12
1
2
1
11.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HBOT
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study is a prospective, case-controlled pilot study, performed over three weeks with 6 participants in each group.The study is a prospective, case-controlled pilot study, performed over three weeks with 6 participants in each group.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effect of Hyperbaric Oxygen Treatment (HBOT) on Recovery From Exercise
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Relative Peak Propulsive Power [within 3 hours of exercise completion during week 2]

    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.

  2. modified Relative Strength Index (mRSI) [within 3 hours of exercise completion during week 2]

    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.

  3. Average Landing Force [within 3 hours of exercise completion during week 2]

    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.

Secondary Outcome Measures

  1. Change in Muscle oxygenation [baseline and week 2]

    Muscle oxygenation will be measured during and post exercise, with and without HBOT using a surface muscle oxygenation monitor on their vastus lateralis.

  2. Change in Blood lactate [baseline and week 2]

    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.

  3. Rate of Perceived Exertion (RPE) scale [daily up to 3 weeks]

    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.

  4. Rate of Perceived Recovery (RPR) scale [daily up to 3 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University New Haven Connecticut United States 06520

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Elizabeth Gardner, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05924035
Other Study ID Numbers:
  • 2000035148
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by Yale University

Study Results

No Results Posted as of Jun 29, 2023