Clinical trial NCT05447416: 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
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Active Athletes
Keywords: triathletes
cyclists
mitochondria
HBOT
HBO
IHT
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-07-07
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trail 2 groups treatment - HBOT and IHT
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiopulmonary exercise test (CPET)
timeFrame: Baseline, 11 weeks
Secondary outcomes:
measure: Cardiopulmonary exercise test (CPET)
timeFrame: 8 weeks, 16 weeks
measure: Time To Exhaustion
timeFrame: Baseline, 11 weeks, 16 weeks
measure: Wingate 30 seconds anaerobic test
timeFrame: Baseline, 11 weeks, 16 weeks
measure: Muscle biopsy for mitochondrial function
timeFrame: Baseline, 11 weeks
measure: Blood test for evaluation of CBC
timeFrame: Baseline, 11 weeks, 16 weeks
measure: Blood test for evaluation of HIF-1α
timeFrame: Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks
measure: Blood test for evaluation of Telomeres length
timeFrame: Baseline,11 weeks, 16 weeks
measure: Blood test for evaluation of mitochondrial function
timeFrame: Baseline,11 weeks
Other outcomes:
measure: Cognitive Function
timeFrame: Baseline, 11 weeks
measure: Cognitive Function under exercise
timeFrame: Baseline, 11 weeks
measure: Whole-brain quantitative perfusion imaging
timeFrame: Baseline, 11 weeks
measure: Brain microstructure MRI evaluation
timeFrame: Baseline, 11 weeks
measure: Brain functional connectivity imaging
timeFrame: Baseline, 11 weeks
measure: Pulse Rate variability and activity
timeFrame: baseline to 16 weeks
Locations:
city: Zrifin
country: Israel
facility: The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Study officials:
affiliation: Asaf-Harofhe MC
name: Shai a Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References: