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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014