Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000299707
Ethics application status
Approved
Date submitted
14/03/2013
Date registered
19/03/2013
Date last updated
19/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving psychological health and decreasing cardiovascular risk post burn injury
Scientific title
Does intensive exercise improve psychological health and decrease cardiovascular risk in patients post burn injury?
Secondary ID [1] 282127 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn injury 288625 0
Psychological health 288637 0
Metabolic profile 288638 0
Condition category
Condition code
Injuries and Accidents 288956 288956 0 0
Burns
Cardiovascular 288977 288977 0 0
Diseases of the vasculature and circulation including the lymphatic system
Mental Health 288978 288978 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be an exercise programme incorporating both aerobic and resisted exercise for three times per week for a total of approximately 60 minutes per session (40 minutes aerobic, 20 minutes resisted) for a 6 week period. This will be in a small group session (2-3 people) supervised by a physiotherapist.

The aerobic component will be conducted on a treadmill, exercise bike or arm ergometer (depending on preference and/or disability (eg injuries to legs), at an intensity of 80 % of VO2peak established during the initial exercise test.

The resisted exercise, the three repetition maximum (3RM) (maximum weight able to be lifted a maximum of 3 times) will be established and exercise commenced at 60% of the 3RM in the first week. Resisted exercise will be progressed weekly by 5-10% by increasing the number of repetitions or the weights lifted. All resisted exercises will be carried out using variable resistance machines or free weights. Exercises included; bench press, leg press, shoulder press, triceps and biceps curl, seated row, resisted shoulder flexion / abduction, toe raises and hand / grip strengthening.

The intervention group will also receive a stretching program, holding all major joints in a stretched position for 15 seconds twice a day.
Intervention code [1] 286731 0
Rehabilitation
Intervention code [2] 286745 0
Lifestyle
Comparator / control treatment
The control group will complete only the stretching program, holding all major joints in a stretched position for 15 seconds twice a day. This will take 30 minutes per day.

The patient will be initally taught this by a physiotherapist but will then complete this exercise session at home unsupervised.
Control group
Active

Outcomes
Primary outcome [1] 289086 0
Free plasma cortisol
Timepoint [1] 289086 0
Baseline, and at 6 and 12 weeks after intervention commencement
Primary outcome [2] 289087 0
Early morning total plasma cortisol
Timepoint [2] 289087 0
Baseline, and at 6 and 12 weeks after intervention commencement
Primary outcome [3] 289088 0
Corticosteroid binding globulin
This will be measured by radioimmunoassay (IBL International GMBH, Hamburg, Germany).
Timepoint [3] 289088 0
Baseline, and at 6 and 12 weeks after intervention commencement
Secondary outcome [1] 301724 0
Insulin sensitivity, glucose and fat metabolism
Plasma glucose (measured enzymatically (Roche/Hitachi 912 automatic analyser; Roche Diagnostics), plasma insulin (DRG Diagnostics) measured using ELISA kits. Insulin resistance will be measured by reciprocal index of homoeostasis model assessment (HOMA-IR).
Timepoint [1] 301724 0
Baseline, and at 6 and 12 weeks after intervention commencement
Secondary outcome [2] 301725 0
Fasting blood lipid profile
Timepoint [2] 301725 0
Baseline, and at 6 and 12 weeks after intervention commencement
Secondary outcome [3] 301739 0
Post-Traumatic Stress Diagnostic Scale (PDS)
Timepoint [3] 301739 0
Baseline, and 6 and 12 weeks after the intervention commencement
Secondary outcome [4] 301740 0
Patient Health Questionnaire-9 (Depression)
Timepoint [4] 301740 0
Baseline, and 6 and 12 weeks after the intervention commencement
Secondary outcome [5] 301741 0
Anxiety scale (GAD-7)
Timepoint [5] 301741 0
Baseline, and 6 and 12 weeks after the intervention commencement
Secondary outcome [6] 301742 0
Resting energy expenditure (REE)
This will be measured via the metalyzer MetaMax 3B analyser (Cortex:biophysik, GMbH, Germany). Actual % REE will be compared with predicted % REE for BMI and age after an overnight fast, resting conditions and controlled ambient temperature 27 degrees celsius, based on the Respiratory quotient based equation.
Timepoint [6] 301742 0
Baseline, and 6 and 12 weeks after the intervention commencement
Secondary outcome [7] 301743 0
Body composition (% fat and lean soft tissue mass) – estimated with dual energy X-ray absorptiometry (DXA)
Timepoint [7] 301743 0
Baseline, and 6 and 12 weeks after the intervention commencement

Eligibility
Key inclusion criteria
1. Patients greater than 18 years of age
2. Percentage total body surface area burns (%TBSA) > 20%
3. Final skin grafting procedure is completed and healed.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with accompanying anoxic brain injury,
2. Type I diabetes,
3. Cardiac disease,
4. Spinal injury,
5. Prior (in the previous 6 months) or current steroid administration,
6. Severe behaviour or cognitive disorders or for compassionate care only will be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Participants living in Brisbane will be randomly allocated to one of two groups with different levels of exercise
2. Those patients not within travelling distance of Brisbane will be in the control group
3. The patient will be approached by one of the research team and asked for inormed consent
4. The person determining whether or not the patient can be included will not be aware of the randomization group as randomization will be done by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomization will be used for participants residing in Brisbane
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
Efficacy
Statistical methods / analysis
1. A mixed method analysis will compare cortisol levels, plasma glucose, HOMA-IR, High sensitivity C- reactive protein, total cholesterol, triglycerides, high density and lipoprotein cholesterol, low density lipoprotein cholesterol, depression and PTSD scores for group*time.

2. Analysis will be by an intention to treat.

3. Correlation co-efficient between levels of cortisol and depression including change in both these parameters.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 771 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 6583 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 286898 0
Hospital
Name [1] 286898 0
Royal Brisbane & Womens Hospital Research Foundation
Country [1] 286898 0
Australia
Primary sponsor type
Individual
Name
Dr Jennifer Paratz
Address
Dept Intensive Care Medicine
Level 3, Ned Hanlon Building,
Royal brisbane & Womens Hospital,
Herston, Qld
4029
Country
Australia
Secondary sponsor category [1] 285685 0
University
Name [1] 285685 0
University of Queensland
Address [1] 285685 0
Dept of Research and Innovation
Cumbrae-Stewart Building
The univeristy of Queensland
St. Lucia QLD 4072
Country [1] 285685 0
Australia
Secondary sponsor category [2] 285696 0
Hospital
Name [2] 285696 0
Royal Brisbane & Womens Hospital
Address [2] 285696 0
Butterfield St,
Herston,
Brisbane, 4029, QLD
Country [2] 285696 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288958 0
Royal Brisbane & Womens Hospital HREC
Ethics committee address [1] 288958 0
Block 7, Floor 7
Royal Brisbane & Womens Hospital
Herston QLD 4029
Ethics committee country [1] 288958 0
Australia
Date submitted for ethics approval [1] 288958 0
29/01/2013
Approval date [1] 288958 0
11/03/2013
Ethics approval number [1] 288958 0
HREC/13/QRBW/16

Summary
Brief summary
This is a double blind randomized trial post burn injury comparing groups receiving either intensive exercise or light exercise. Outcome measures will be levels of cortisol, lipids, resting energy expenditure, body composition, depression, post traumatic stress syndrome and generalized anxiety disorder.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38502 0
Dr Jennifer Paratz
Address 38502 0
Dept Intensive Care Medicine,
Level 3, NHB
Royal Brisbane & Womens Hospital,
Herston QLD,4029
Country 38502 0
Australia
Phone 38502 0
61 7 36461980
Fax 38502 0
61 7 36463542
Email 38502 0
[email protected]
Contact person for public queries
Name 38503 0
Dr Jennifer Paratz
Address 38503 0
Dept Intensive Care Medicine,
Level 3, NHB
Royal Brisbane & Womens Hospital,
Herston QLD,4029
Country 38503 0
Australia
Phone 38503 0
61 7 36461980
Fax 38503 0
61 7 36463542
Email 38503 0
[email protected]
Contact person for scientific queries
Name 38504 0
Dr Jennifer Paratz
Address 38504 0
Dept Intensive Care Medicine,
Level 3, NHB
Royal Brisbane & Womens Hospital,
Herston QLD,4029
Country 38504 0
Australia
Phone 38504 0
61 7 36461980
Fax 38504 0
61 7 36463542
Email 38504 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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