Exercise Training Post Burn Injury

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01368367
• Other study ID #: ETPB1
• Status: Active, not recruiting
• Phase: N/A
• First received: May 27, 2011
• Last updated: June 6, 2011
• Start date: December 2007
• Est. completion date: December 2012

Study information

• Verified date: November 2010
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Burns

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Brisbane & Womens Hospital	Brisbane	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
The University of Queensland	Royal Brisbane and Women's Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to six weeks, change from 6 weeks to 12 weeks	No
Secondary	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.	Change from baseline to six weeks, change from 6 weeks to 12 weeks	No
Secondary	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).	Change from baseline to six weeks, change from 6 weeks to 12 weeks	No
Secondary	Resting heart rate (beats/minute)	Resting heart rate was recorded by a polar heart rate monitor (PE3000, Polar Electro, Kemple, Finland) in beats/minute.	Change from baseline to six weeks, change from 6 weeks to 12 weeks	No
Secondary	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.	Change from baseline to six weeks, change from 6 weeks to 12 weeks	No
Secondary	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.	Change from baseline to six weeks, change from 6 weeks to 12 weeks	No
Secondary	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.	Change from baseline to six weeks, change from 6 weeks to 12 weeks	No
Secondary	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.	Change from baseline to six weeks, change from 6 weeks to 12 weeks	No