Clinical Trial: Exercise Training Post Burn Injury

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Safety and Efficacy of Exercise Training Post Burn Injury: a Randomized Controlled Trial

Brief Summary: The purpose of this study is to determine whether a high intensity aerobic and resisted exercise program will improve physical, functional and psychological outcomes in patients post burn injury.

Detailed Summary:

Even though immediate and early death from severe thermal injury has reduced over the last twenty years, considerable physical and psychosocial morbidity still persists. While exercise is strongly recommended to assist recovery and overall outcome, there is limited evidence in adults to indicate whether it is effective and/or safe.

This study will investigate the effect of a high intensity aerobic and resisted exercise program exercise program on safety, physical, functional and quality of life measures in adults post burn injury.


Sponsor: The University of Queensland

Current Primary Outcome: Burns Specific Health Scale - Abbreviated (BSHS-A) [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ]

The BSHS-A is an injury specific self reported questionnaire consisting of 80 questions encompassing four primary domains namely physical, psychological, social and general, with reports of good internal consistency, test/ retest reliability and strong convergent validity data.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The modified shuttle walk test (MSWT) [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ]
    The modified shuttle walk test (MSWT) is an established test of functional exercise capacity. It is an objective measure with 15 incremental levels of both walking and running. Total distance acheived will be recorded.
  • VO2peak (ie the volume of oxygen consumed by the cells at the most intensive level during the exercise test) [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ]
    VO2peak (ie the volume of oxygen consumed by the cells at the most intensive level during the modified shuttle walk test) will be recorded by a portable metabolic monitor (Metalyzer 3B analyser (Cortex:biophysik, GMbH, Germany) Cortex MetaMax 3B).
  • Resting heart rate (beats/minute) [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ]
    Resting heart rate was recorded by a polar heart rate monitor (PE3000, Polar Electro, Kemple, Finland) in beats/minute.
  • Muscle strength [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ]
    Muscle Strength - a baseline measure of the quadriceps and latisimuss dorsi muscles will be taken by the one repetition maximum or 1RM. This is the maximum amount of weight one can lift in a single repetition for a given exercise and has been utilized as an outcome measure in subjects post burns.
  • Grip strength [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ]
    Grip strength will be measured using a Jamar dynamometer as per the protocol for the American Hand Therapists Society with an average of three measurements taken. This dynamometer is a hydraulic appliance which can measure grip strength in five alternate grip position settings. This has been shown to have good reliability and validity and is considered the gold standard of hand grip measurement.
  • QuickDash [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ]
    The Quick disabilities of the arm, shoulder and hand (QuickDASH)is a self rated questionnaire on upper limb function with good repeatability, validity and responsiveness in burns patients. Sixty percent of the questions relate to overall upper limb disability with the remainder of the optional questions relating to work, sports and musical activities. Lower scores on this scale indicate less disability of the upper limb.
  • The Lower Extremity Functional Scale (LEFS) [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ]
    The Lower Extremity Functional Scale (LEFS) measures disability related to the lower extremities with regard to work, activities of daily living and recreation and has been shown to have sensitivity to change in burns patients and excellent test-retest reliability and construct validity in general patients. Higher scores indicate less disability with a possible total of 80.


Original Secondary Outcome: Same as current

Information By: The University of Queensland

Dates:
Date Received: May 27, 2011
Date Started: December 2007
Date Completion: December 2012
Last Updated: June 6, 2011
Last Verified: November 2010