Overview

This trial is active, not recruiting.

Condition burns
Treatment intensive exercise
Sponsor The University of Queensland
Collaborator Royal Brisbane and Women's Hospital
Start date December 2007
End date November 2012
Trial size 36 participants
Trial identifier NCT01368367, ETPB1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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)
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.

Primary Outcomes

Measure
Burns Specific Health Scale - Abbreviated (BSHS-A)
time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks

Secondary Outcomes

Measure
The modified shuttle walk test (MSWT)
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 exercise test)
time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Resting heart rate (beats/minute)
time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Muscle strength
time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Grip strength
time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
QuickDash
time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
The Lower Extremity Functional Scale (LEFS)
time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Safety and Efficacy of Exercise Training Post Burn Injury: a Randomized Controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by The University of Queensland.