COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01368367




Registration number
NCT01368367
Ethics application status
Date submitted
27/05/2011
Date registered
7/06/2011
Date last updated
7/06/2011

Titles & IDs
Public title
Exercise Training Post Burn Injury
Scientific title
Safety and Efficacy of Exercise Training Post Burn Injury: a Randomized Controlled Trial
Secondary ID [1] 0 0
ETPB1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Intensive exercise

Active Comparator: Intensive exercise group -

Placebo Comparator: Stretch exercise only -


Other interventions: 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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [3] 0 0
Resting heart rate (beats/minute) - Resting heart rate was recorded by a polar heart rate monitor (PE3000, Polar Electro, Kemple, Finland) in beats/minute.
Timepoint [3] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks

Eligibility
Key inclusion criteria
- Burns greater than 20% total body surface area

- 18 years of age and over

- English speaking

- Post final grafting procedure
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane & Womens Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Brisbane and Women's Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01368367
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01368367