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| ID | Type | Description | Link |
|---|---|---|---|
| RPP-3 | Other Grant/Funding Number | NORP Inc. |
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Since hydrogen therapy in humans seems to be beneficial for treating inflammation, ischemia-reperfusion injury and oxidative stress, it seems plausible to evaluate the effects of exogenously administered hydrogen as an element of instant management of sport-related soft tissue injuries (e.g. muscle sprain, ligament strain, tendonitis, contusion). The main aim of the present study will be to examine the effects of two-week hydrogen-rich oral and topical administration on the inflammation, recovery and functional abilities in competitive male and female athletes after acute soft-tissue injury. During the season 2012/2013 (from February to June) subjects (36 professional athletes) will be recruited and examined by certified sports medicine specialist in the out-patient clinics of the Center for Health, Exercise and Sport Sciences in the first 24 hours after the sport-related soft tissue injury was sustained. The subjects will be allocated to a double-blind design to three randomly assigned trials. During the period of 2 weeks subjects in the placebo group (PLA) will receive traditional treatment protocol after the soft-tissue injury, consisting of RICE protocol during the first 48 h and sub-acute protocol thereafter. Subjects in the first experimental group will follow the above procedures with additional administration of oral hydrogen-rich capsules (4 capsules three times per day) throughout the study. Subjects in the second experimental group will follow the procedures of first experimental group with additional administration of hydrogen-rick packs 6 times per day for 20 minutes throughout the study. Participants will be evaluated at the beginning of the study (e.g. at the time of the injury report), after 7 and 14 days after baseline testing for: a) serum C-reactive protein, plasma viscosity and interleukin 6 level, b) pain intensity during rest and walking, c) degree of joint swelling, d) passive joint flexibility, and, e) subjective side-effects. The investigators expect that the administration of hydrogen will significantly improve inflammation outcomes (e.g. decrease in serum C-reactive protein) as compared to the placebo, with topical hydrogen administration will additionally improve post-injury recovery outcomes (e.g. pain intensity, degree of swelling). These results could support the hypothesis that hydrogen-rich intervention may be included as an element of immediate treatment for sport-related soft tissue injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYDRO 2 | Experimental | Subjects in the second experimental group will follow the procedures of first experimental group with additional administration of hydrogen-rick packs 6 times per day for 20 minutes throughout the study. |
|
| ACTIVE | Active Comparator | During the period of 2 weeks subjects will receive traditional treatment protocol after the soft-tissue injury, consisting of RICE protocol during the first 48 h (e.g. rest, ice packs for 20 minutes every 2 hours, compression with elastic bandage, elevation of the injured area above the level of the heart at all possible times) and sub-acute protocol thereafter (e.g. passive stretching 3 times per day for 90 sec, isometric strength exercise with 3 sets with 15 repetitions, 30 min of pain-free weight-bearing exercise). |
|
| HYDRO | Experimental | Subjects in the first experimental group will follow the PLA procedures with additional administration of oral hydrogen-rich capsules (4 capsules three times per day) throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYDRO | Dietary Supplement |
| ||
| ACTIVE |
| Measure | Description | Time Frame |
|---|---|---|
| change in serum C-reactive protein | every week, up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in pain intensity during rest and walking | every week, up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in degree of joint swelling | every week, up to 2 weeks | |
| change in passive joint flexibility | every week, up to 2 weeks | |
| change in plasma viscosity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergej M Ostojic, MD, PhD | Center for Health, Exercise and Sport Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Health, Exercise and Sport Sciences | Belgrade | 11000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22560529 | Background | Ostojic SM. Serum alkalinization and hydrogen-rich water in healthy men. Mayo Clin Proc. 2012 May;87(5):501-2. doi: 10.1016/j.mayocp.2012.02.008. No abstract available. | |
| 18191749 | Background | Jackson MJ. Free radicals generated by contracting muscle: by-products of metabolism or key regulators of muscle function? Free Radic Biol Med. 2008 Jan 15;44(2):132-41. doi: 10.1016/j.freeradbiomed.2007.06.003. Epub 2007 Jun 13. |
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| ID | Term |
|---|---|
| D017695 | Soft Tissue Injuries |
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| HYDRO 2 | Dietary Supplement |
|
| every week, up to 2 weeks |
| change in serum interleukin 6 | every week, up to 2 weeks |
| 22720117 | Background | Ohno K, Ito M, Ichihara M, Ito M. Molecular hydrogen as an emerging therapeutic medical gas for neurodegenerative and other diseases. Oxid Med Cell Longev. 2012;2012:353152. doi: 10.1155/2012/353152. Epub 2012 Jun 8. |
| 25295663 | Derived | Ostojic SM, Vukomanovic B, Calleja-Gonzalez J, Hoffman JR. Effectiveness of oral and topical hydrogen for sports-related soft tissue injuries. Postgrad Med. 2014 Sep;126(5):187-95. doi: 10.3810/pgm.2014.09.2813. |
| D012816 | Signs and Symptoms |