NCT05924035

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

June 15, 2023

Last Update Submit

July 11, 2023

Conditions

Exercise Recovery

Keywords

Hyperbaric Oxygen TreatmentExercise RecoveryHigh Performance Athletes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Change in Muscle oxygenation

    baseline and week 2

  • Change in Blood lactate

    baseline and week 2

  • Rate of Perceived Exertion (RPE) scale

    daily up to 3 weeks

  • Rate of Perceived Recovery (RPR) scale

    daily up to 3 weeks

Study Arms (2)

Control Group

NO INTERVENTION

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)

HBOT Treatment

EXPERIMENTAL

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

Interventions

HBOTDEVICE

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.

HBOT Treatment

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Study Officials

  • Elizabeth Gardner, MD

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study is a prospective, case-controlled pilot study, performed over three weeks with 6 participants in each group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2023

First Posted

June 29, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Locations

US(1)