Exercise Training Post Burn Injury
Primary Purpose
Burns
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Intensive exercise
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Burns
Eligibility 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
Sites / Locations
- Royal Brisbane & Womens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intensive exercise group
Stretch exercise only
Arm Description
Outcomes
Primary Outcome Measures
Burns Specific Health Scale - Abbreviated (BSHS-A)
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)
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)
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)
Resting heart rate was recorded by a polar heart rate monitor (PE3000, Polar Electro, Kemple, Finland) in beats/minute.
Muscle strength
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
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
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)
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.
Full Information
NCT ID
NCT01368367
First Posted
May 27, 2011
Last Updated
June 6, 2011
Sponsor
The University of Queensland
Collaborators
Royal Brisbane and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01368367
Brief Title
Exercise Training Post Burn Injury
Official Title
Safety and Efficacy of Exercise Training Post Burn Injury: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Queensland
Collaborators
Royal Brisbane and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive exercise group
Arm Type
Active Comparator
Arm Title
Stretch exercise only
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Intensive exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Burns Specific Health Scale - Abbreviated (BSHS-A)
Description
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.
Time Frame
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary Outcome Measure Information:
Title
The modified shuttle walk test (MSWT)
Description
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.
Time Frame
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Title
VO2peak (ie the volume of oxygen consumed by the cells at the most intensive level during the exercise test)
Description
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).
Time Frame
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Title
Resting heart rate (beats/minute)
Description
Resting heart rate was recorded by a polar heart rate monitor (PE3000, Polar Electro, Kemple, Finland) in beats/minute.
Time Frame
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Title
Muscle strength
Description
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.
Time Frame
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Title
Grip strength
Description
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.
Time Frame
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Title
QuickDash
Description
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.
Time Frame
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Title
The Lower Extremity Functional Scale (LEFS)
Description
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.
Time Frame
Change from baseline to six weeks, change from 6 weeks to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Royal Brisbane & Womens Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
12. IPD Sharing Statement
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Exercise Training Post Burn Injury
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