Healthy Clinical Trial
— SPORTRCTOfficial title:
The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
Verified date | December 2022 |
Source | Assaf-Harofeh Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | September 15, 2021 |
Est. primary completion date | September 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 18-25 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 Exclusion Criteria: - Debilitating significant musculoskeletal injury - Previous hyperbaric oxygen exposure - Lung pathology - Middle or Inner ear pathology - Claustrophobia - Chronic illness - Smoking - Chronic medications |
Country | Name | City | State |
---|---|---|---|
Israel | Assaf-Harofeh Medical Center | Ramla |
Lead Sponsor | Collaborator |
---|---|
Assaf-Harofeh Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from baseline of maximal respiratory rate | Using a trucut needle, the gluteus maximus will be sampled in a sterile technique for 1-2mg of muscle tissue. Oroboros O2k high resolution respirometry analyzer will be used (Oxygraph-2k Oroboros Instruments, Innsbruck, Austria). Maximal respiration rate (nmol/ml) will be calculated. | baseline, at 2 months, at 4 months | |
Secondary | Change from baseline of basal respiration rate | Using a trucut needle, the gluteus maximus will be sampled in a sterile technique for 1-2mg of muscle tissue. Oroboros O2k high resolution respirometry analyzer will be used (Oxygraph-2k Oroboros Instruments, Innsbruck, Austria). Basal respiration rate (nmol/ml) will be measured where mitochondrial reserve capacity and ATP-linked respiration will be calculated. | baseline, at 2 months, at 4 months | |
Secondary | Change from baseline of respiration independent adenosine triphosphate (ATP) production (in muscle biopsy | Using a trucut needle, the gluteus maximus will be sampled in a sterile technique for 1-2mg of muscle tissue. Oroboros O2k high resolution respirometry analyzer will be used (Oxygraph-2k Oroboros Instruments, Innsbruck, Austria). Inpendent adenosine triphosphate (ATP) production (proton leak) (nmol/ml) will be calculated. | baseline, at 2 months, at 4 months | |
Secondary | Change from baseline in body fat/muscle ratio | Using an electric current weight, the fat % and muscle % content will be measured. | baseline, at 2 months, at 4 months | |
Secondary | Change in maximal vertical jump (meters) | Maximal running speed, maximal vertical jump height will be measured according the standards. | baseline, at 2 months, at 4 months | |
Secondary | Change in maximal running speed (km/hr) | Maximal running speed will be measured according the standards. | baseline, at 2 months, at 4 months | |
Secondary | Change in forced expiratory volume at one second (FEV1) | Using a standard spirometry, forced expiratory volume at one second (FEV1) (liters/second) will be measured | baseline, at 2 months, at 4 months | |
Secondary | Change in forced volume capacity (FVC) | Using a standard spirometry, forced volume capacity (FVC) (liters/second) will be measured | baseline, at 2 months, at 4 months | |
Secondary | Change in general cognitive function | Patients' cognitive functions will be assessed by Neurotrax computerized cognitive tests to generate the general cognitive index (0-100) | baseline, at 2 months, at 4 months | |
Secondary | Change from baseline of brain blood perfusion in brain MRI | imaging will be performed for evaluation of brain changes and angiogenesis process using MRI perfusion and microstructure | baseline, at 2 months, at 4 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |