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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia
ClinicalTrials.gov Identifier:
NCT01759498
First received: December 25, 2012
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Soft Tissue Injuries
Dietary Supplement: HYDRO
Dietary Supplement: ACTIVE
Dietary Supplement: HYDRO 2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Center for Health, Exercise and Sport Sciences, Serbia:

Primary Outcome Measures:
  • change in serum C-reactive protein [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in pain intensity during rest and walking [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • change in degree of joint swelling [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
  • change in passive joint flexibility [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
  • change in plasma viscosity [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
  • change in serum interleukin 6 [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759498

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

Additional Information:
Publications:
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     History of Changes
Other Study ID Numbers: 012-12C/4, RPP-3
Study First Received: December 25, 2012
Last Updated: September 27, 2013
Health Authority: Serbia: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on April 22, 2014