Exercise Training Post Burn Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by The University of Queensland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Royal Brisbane and Women's Hospital
Information provided by:
The University of Queensland
ClinicalTrials.gov Identifier:
NCT01368367
First received: May 27, 2011
Last updated: June 6, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention
Burns
Other: Intensive exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Exercise Training Post Burn Injury: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of Queensland:

Primary Outcome Measures:
  • Burns Specific Health Scale - Abbreviated (BSHS-A) [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The modified shuttle walk test (MSWT) [ Time Frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: December 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intensive exercise group Other: Intensive exercise
Both groups, stretching exercise monitored once per week Intensive exercise group An aerobic and resisted exercise program for a minimum of three times per week for a total of approximately 60 minutes per session for six weeks. Aerobic exercise will be conducted on a treadmill, exercise bike or arm ergometer at an intensity of 80 % of VO2peak during initial assessment. For resistance exercise, the three repetition maximum (3RM) (maximum weight able to be lifted a maximum of 3 times) will be established and then resisted exercise will be commenced at 60% of the 3RM in the first week. Resisted exercise will then be progressed weekly by 5-10% by increasing the number of repetitions or the weights lifted. All resisted exercises will be done using variable resistance machines or free weights.
Placebo Comparator: Stretch exercise only Other: Intensive exercise
Both groups, stretching exercise monitored once per week Intensive exercise group An aerobic and resisted exercise program for a minimum of three times per week for a total of approximately 60 minutes per session for six weeks. Aerobic exercise will be conducted on a treadmill, exercise bike or arm ergometer at an intensity of 80 % of VO2peak during initial assessment. For resistance exercise, the three repetition maximum (3RM) (maximum weight able to be lifted a maximum of 3 times) will be established and then resisted exercise will be commenced at 60% of the 3RM in the first week. Resisted exercise will then be progressed weekly by 5-10% by increasing the number of repetitions or the weights lifted. All resisted exercises will be done using variable resistance machines or free weights.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Burns greater than 20% total body surface area
  • 18 years of age and over
  • English speaking
  • Post final grafting procedure

Exclusion Criteria:

  • Accompanying anoxic brain injury
  • Cardiac disease or injury (American College of Sports medicine ACSM criteria)
  • Quadriplegia
  • Severe behaviour or cognitive disorders
  • Compassionate care only
  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: NCT01368367

Locations
Australia, Queensland
Royal Brisbane & Womens Hospital
Brisbane, Queensland, Australia, 4029
Sponsors and Collaborators
The University of Queensland
Royal Brisbane and Women's Hospital
  More Information

No publications provided

Responsible Party: Dr Jennifer Paratz, University of Queensland
ClinicalTrials.gov Identifier: NCT01368367     History of Changes
Other Study ID Numbers: ETPB1
Study First Received: May 27, 2011
Last Updated: June 6, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The University of Queensland:
Burns

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014