NCT03524989

Brief Summary

Previous evidence showed hyperbaric oxygen can enhance aerobic and anaerobic performance during the exposure. The effect of continuous exposure of hyperbaric oxygen on performance was never evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

3.3 years

First QC Date

April 30, 2018

Last Update Submit

December 5, 2022

Conditions

HealthyAthletes

Keywords

hbothyperbaric oxygensportmitochondriaathletesaerobic

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of exercise VO2 MAX at 2 months and 4 months

    Using a standard exercise test which includes gas analysis, the change in VO2 maxs will be assessed 2 months and 4 months compared to baseline

    baseline, at 2 months, 4 months

Secondary Outcomes (10)

  • Change from baseline of maximal respiratory rate

    baseline, at 2 months, at 4 months

  • Change from baseline of basal respiration rate

    baseline, at 2 months, at 4 months

  • Change from baseline of respiration independent adenosine triphosphate (ATP) production (in muscle biopsy

    baseline, at 2 months, at 4 months

  • Change from baseline in body fat/muscle ratio

    baseline, at 2 months, at 4 months

  • Change in maximal vertical jump (meters)

    baseline, at 2 months, at 4 months

  • +5 more secondary outcomes

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Hyperbaric Oxygen Therapy: 2 months of treatment consisting of 40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week

Device: Hyperbaric Oxygen Therapy

Control/Crossover

SHAM COMPARATOR

SHAM therapy: 2 months of treatment consisting of 40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week

Device: SHAM treatment

Interventions

Hyperbaric Oxygen TherapyDEVICE

40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months.

Treatment
SHAM treatmentDEVICE

40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months.

Control/Crossover

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • or 40-50 age
  • Professional performance of aerobic sports for ages 18-25 (at least 5 times a week)
  • Moderate and above performance of aerobic sports for ages 40-50 (at least 4 times a week)
  • no chronic illness
  • no significant musculoskeletal injury in the past 3 months

You may not qualify if:

  • Debilitating significant musculoskeletal injury
  • Previous hyperbaric oxygen exposure
  • Lung pathology
  • Middle or Inner ear pathology
  • Claustrophobia
  • Chronic illness
  • Smoking
  • Chronic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh Medical Center

Ramla, 70300, Israel

Location

Related Publications (1)

  • Hadanny A, Hachmo Y, Rozali D, Catalogna M, Yaakobi E, Sova M, Gattegno H, Abu Hamed R, Lang E, Polak N, Friedman M, Finci S, Zemel Y, Bechor Y, Gal N, Efrati S. Effects of Hyperbaric Oxygen Therapy on Mitochondrial Respiration and Physical Performance in Middle-Aged Athletes: A Blinded, Randomized Controlled Trial. Sports Med Open. 2022 Feb 8;8(1):22. doi: 10.1186/s40798-021-00403-w.

    PMID: 35133516DERIVED

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized blinded controlled 2 groups with SHAM treatment
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 15, 2018

Study Start

May 15, 2018

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

December 6, 2022

Record last verified: 2022-12

Locations

IL(1)