The Effects of Hydrogen-rich Formulation for Treatment of Sport-related Soft Tissue Injuries

• ClinicalTrials.gov Identifier: NCT01759498
• Recruitment Status: Completed
• First Posted: January 3, 2013
• Last Update Posted: October 1, 2013
• Sponsor: Center for Health, Exercise and Sport Sciences, Serbia
• Information provided by (Responsible Party): Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Soft Tissue Injuries	Dietary Supplement: HYDRO; Dietary Supplement: ACTIVE; Dietary Supplement: HYDRO 2	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: December 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: HYDRO 2; 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.	Dietary Supplement: HYDRO 2
Active Comparator: ACTIVE; 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).	Dietary Supplement: ACTIVE
Experimental: HYDRO; 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.	Dietary Supplement: HYDRO

Outcome Measures

Primary Outcome Measures :

1. change in serum C-reactive protein [ Time Frame: every week, up to 2 weeks ]

Secondary Outcome Measures :

1. change in pain intensity during rest and walking [ Time Frame: every week, up to 2 weeks ]

Other Outcome Measures:

1. change in degree of joint swelling [ Time Frame: every week, up to 2 weeks ]
2. change in passive joint flexibility [ Time Frame: every week, up to 2 weeks ]
3. change in plasma viscosity [ Time Frame: every week, up to 2 weeks ]
4. change in serum interleukin 6 [ Time Frame: every week, up to 2 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• recent history of acute soft-tissue sports injury
• professional athletes

Exclusion Criteria:

• not ambulatory patients
• clinical findings classed as more severe than grade II

Contacts and Locations

Locations

Serbia

Center for Health, Exercise and Sport Sciences

Belgrade, Serbia, 11000

Sponsors and Collaborators

Center for Health, Exercise and Sport Sciences, Serbia

Investigators

• Principal Investigator: Sergej M Ostojic, MD, PhD; Center for Health, Exercise and Sport Sciences

More Information

Publications:

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.

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. Review.

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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Assoc. Prof. Sergej M. Ostojic, MD, PhD, Head of Human Performance Laboratory, Center for Health, Exercise and Sport Sciences, Serbia
• ClinicalTrials.gov Identifier: NCT01759498
• Other Study ID Numbers: 012-12C/4; RPP-3 ( Other Grant/Funding Number: NORP Inc. )
• First Posted: January 3, 2013
• Last Update Posted: October 1, 2013
• Last Verified: September 2013

Keywords provided by Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia:

Inflammation; Pain intensity; Flexibility; RICE protocol; Swelling

Additional relevant MeSH terms:

Soft Tissue Injuries; Wounds and Injuries