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Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance

Primary Purpose

Healthy Active Athletes

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy - HBOT
Intermittent Hypoxic Training - IHT
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Active Athletes focused on measuring triathletes, cyclists, mitochondria, HBOT, HBO, IHT

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Vo2max above 3500 ml or Vo2max/kg above 50 ml/kg
  2. Age 18-45
  3. Subjects are active aerobic athletes, training regularly more than 4 exercise sessions per week.
  4. Subject willing and able to read, understand and sign an informed consent

Exclusion Criteria:

  1. Inability to attend scheduled clinic visits and/or comply with the study protocol
  2. Active malignancy
  3. Active smokers
  4. Previous treatment of HBOT for any reason prior to study enrollment.
  5. Chest pathology incompatible with pressure changes
  6. Major orthopedic injury at the past 3 months
  7. Inner ear disease
  8. Lung pathology
  9. The inability to perform an awake brain MRI
  10. Claustrophobia
  11. Previous neurologic conditions (e.g., Epilepsy, Brain tumors or s/p neurosurgery etc.)
  12. Comorbidities and medications that rule out the subject

Sites / Locations

  • The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hyperbaric Oxygen Therapy - HBOT

Intermittent Hypoxic Training - IHT

Arm Description

The protocol comprises of 40 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a two months' period. The HBOT group will train for 60 minutes after the HBOT sessions, 3 times per week, in a normobaric normoxic environment according to individualized training protocol

The protocol comprises of 24 consecutive Intermittent Hypoxic Training (IHT) sessions, 3 sessions per week within a two months' period. Subjects will train according to individualized training protocol.

Outcomes

Primary Outcome Measures

Cardiopulmonary exercise test (CPET)
CPET determines the gas exchange dynamics that is expected to change through the intervention

Secondary Outcome Measures

Cardiopulmonary exercise test (CPET)
CPET determines the gas exchange dynamics that is expected to change through the intervention
Time To Exhaustion
The test will be conducted on the SRM high performance ergometer on 105% of the maximal aerobic power
Wingate 30 seconds anaerobic test
The Wingate Anaerobic Test (WAnT) is conducted on the SRM high performance ergometer.
Muscle biopsy for mitochondrial function
Participants will undergo a muscle biopsy, muscle sample will be analyzed using the Oxygraph (Oroboros Inc, Austria) for oxygen respiratory function, as well as staining for mitochondrial proteins
Blood test for evaluation of CBC
complete blood count
Blood test for evaluation of HIF-1α
Hypoxic inducible factor 1α levels
Blood test for evaluation of Telomeres length
Using staining and FACS technology telomere length will be analyzed
Blood test for evaluation of mitochondrial function
Mitochondrial function of Peripheral Blood Mononuclear Cells (PBMC) and Platelets (PLT)

Full Information

First Posted
July 3, 2022
Last Updated
July 10, 2023
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05447416
Brief Title
Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance
Official Title
Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance - Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparing the effect of HBOT and IHT on aerobic performance of athletes.
Detailed Description
Enhanced physical performance is the goal of all professional and non-professional athletes. There are many intervention methods aim to enhance physical performance from 2 intervention related to change in the environment partial oxygen pressure have been demonstrated to have beneficial effect: IHT and HBOT. This study offers one of the two interventions to athletes with a pre and post intervention objective evaluation of the physiological performance - Maximal exercise test for evaluating VO2MAX and ventilatory thresholds, time to exhaustion, 30 seconds Wingate test, agility test, muscle biopsy, blood tests, brain MRI, cognitive tests and exercise cognitive test. After signing an informed consent form, eligible subjects will be randomized to one of the study groups at a ratio of 1:1. The IHT group will receive three hypoxic guided training sessions per week, according an individualized training protocol, 24 sessions in total. The HBOT group will receive 40 daily hyperbaric sessions, five days per week. Each session will include 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Three times per week, as the IHT group, the HBOT group will have a guided training session, according an individualized training protocol. Both groups, IHT and HBOT, will have the same relative intensity guided training protocols for 8 weeks, to stimulate the same exercise load. The IHT group will train for 60 minutes, 3 times a week in a normobaric hypoxia environment, at O2 concentration of 15.2% that stimulates a 2500-2600m height. The HBOT group will train for 60 minutes after the HBOT sessions, 3 times per week, in a normobaric normoxic environment Physical performance evaluations will be conducted on 3 different times post interventions - a day last intervention, 3 weeks after and 2 months after - in order to analyze the long term effect of each intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Active Athletes
Keywords
triathletes, cyclists, mitochondria, HBOT, HBO, IHT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trail 2 groups treatment - HBOT and IHT
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric Oxygen Therapy - HBOT
Arm Type
Active Comparator
Arm Description
The protocol comprises of 40 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a two months' period. The HBOT group will train for 60 minutes after the HBOT sessions, 3 times per week, in a normobaric normoxic environment according to individualized training protocol
Arm Title
Intermittent Hypoxic Training - IHT
Arm Type
Active Comparator
Arm Description
The protocol comprises of 24 consecutive Intermittent Hypoxic Training (IHT) sessions, 3 sessions per week within a two months' period. Subjects will train according to individualized training protocol.
Intervention Type
Device
Intervention Name(s)
Hyperbaric Oxygen Therapy - HBOT
Intervention Description
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Intervention Type
Device
Intervention Name(s)
Intermittent Hypoxic Training - IHT
Intervention Description
Each session lasts 60 minutes of 15.2% oxygen at 1.0 ATA. Subjects will be training according to individualized training protocol.
Primary Outcome Measure Information:
Title
Cardiopulmonary exercise test (CPET)
Description
CPET determines the gas exchange dynamics that is expected to change through the intervention
Time Frame
Baseline, 11 weeks
Secondary Outcome Measure Information:
Title
Cardiopulmonary exercise test (CPET)
Description
CPET determines the gas exchange dynamics that is expected to change through the intervention
Time Frame
8 weeks, 16 weeks
Title
Time To Exhaustion
Description
The test will be conducted on the SRM high performance ergometer on 105% of the maximal aerobic power
Time Frame
Baseline, 11 weeks, 16 weeks
Title
Wingate 30 seconds anaerobic test
Description
The Wingate Anaerobic Test (WAnT) is conducted on the SRM high performance ergometer.
Time Frame
Baseline, 11 weeks, 16 weeks
Title
Muscle biopsy for mitochondrial function
Description
Participants will undergo a muscle biopsy, muscle sample will be analyzed using the Oxygraph (Oroboros Inc, Austria) for oxygen respiratory function, as well as staining for mitochondrial proteins
Time Frame
Baseline, 11 weeks
Title
Blood test for evaluation of CBC
Description
complete blood count
Time Frame
Baseline, 11 weeks, 16 weeks
Title
Blood test for evaluation of HIF-1α
Description
Hypoxic inducible factor 1α levels
Time Frame
Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks
Title
Blood test for evaluation of Telomeres length
Description
Using staining and FACS technology telomere length will be analyzed
Time Frame
Baseline,11 weeks, 16 weeks
Title
Blood test for evaluation of mitochondrial function
Description
Mitochondrial function of Peripheral Blood Mononuclear Cells (PBMC) and Platelets (PLT)
Time Frame
Baseline,11 weeks
Other Pre-specified Outcome Measures:
Title
Cognitive Function
Description
Cognitive function will be evaluated using the Neurotrax computerized cognitive assessment and the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Time Frame
Baseline, 11 weeks
Title
Cognitive Function under exercise
Description
Participants will be asked to pedal on a bike on workload correlated to 85% of the second ventilatory threshold obtained during the CPET and will simultaneously perform a Stroop test using the EncephalApp Stroop Test application on a tablet.
Time Frame
Baseline, 11 weeks
Title
Whole-brain quantitative perfusion imaging
Description
Whole-brain quantitative perfusion imaging will be performed using Dynamic susceptibility contrast (DSC)-MRI technique
Time Frame
Baseline, 11 weeks
Title
Brain microstructure MRI evaluation
Description
Fractional anisotropy (FA) and Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol
Time Frame
Baseline, 11 weeks
Title
Brain functional connectivity imaging
Description
Resting state functional MRI
Time Frame
Baseline, 11 weeks
Title
Pulse Rate variability and activity
Description
Participants will be asked to wear a smartwatch (Garmin, USA) in the entire time frame of the study.
Time Frame
baseline to 16 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
male biologically
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Vo2max above 3500 ml or Vo2max/kg above 50 ml/kg Age 18-45 Subjects are active aerobic athletes, training regularly more than 4 exercise sessions per week. Subject willing and able to read, understand and sign an informed consent Exclusion Criteria: Inability to attend scheduled clinic visits and/or comply with the study protocol Active malignancy Active smokers Previous treatment of HBOT for any reason prior to study enrollment. Chest pathology incompatible with pressure changes Major orthopedic injury at the past 3 months Inner ear disease Lung pathology The inability to perform an awake brain MRI Claustrophobia Previous neurologic conditions (e.g., Epilepsy, Brain tumors or s/p neurosurgery etc.) Comorbidities and medications that rule out the subject
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shai Efrati, Prof
Phone
972-8-9779393
Email
efratishai@outlook.com
Facility Information:
Facility Name
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
City
Zrifin
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shai Efrati, Prof
Phone
972-8-9779393
Email
efratishai@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance

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