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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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)
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)
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)
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)
Timepoint [3] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [4] 0 0
Muscle strength
Timepoint [4] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [5] 0 0
Grip strength
Timepoint [5] 0 0
Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcome [6] 0 0
QuickDash
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)
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
Sex
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
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2012
Actual
Sample size
Target
36
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/ct2/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/ct2/show/NCT01368367