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Trial registered on ANZCTR


Registration number
ACTRN12614001156673
Ethics application status
Approved
Date submitted
24/09/2014
Date registered
31/10/2014
Date last updated
10/03/2020
Date data sharing statement initially provided
10/03/2020
Date results information initially provided
10/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does resistance exercise training improve muscle strength and function in acute burn injury?
Scientific title
A randomised, controlled trial investigating the effect of resistance training on muscle strength, function and quality of life in acute burn injury.
Secondary ID [1] 285396 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns 293133 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293402 293402 0 0
Physiotherapy
Injuries and Accidents 293685 293685 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both intervention (EIG) and control (CG) groups will receive standard Physiotherapy input which typically consists of bi-daily intervention.

The EIG will undergo a prescribed resistance exercise program in their afternoon Physiotherapy session which will last for approximately 60 mins, three times per week.

The resistance training program will be Physiotherapy-led and will comprise 3 sets of 10 repetitions of exercises for shoulders, biceps, triceps, quadriceps and lower limb complex at a load of 70% of 1 repetition max, as determined by pre-session strength assessments.

The intervention period will continue for 4 weeks. There will be a break from intervention of at least 3 days following skin grafting procedures to allow for adequate wound healing. Assuming each patient will undergo one surgical procedure, we will aim for a minimum 10 exercise sessions for each patient during the intervention period. This may require addiditonal sesisons beyond the 4 week period to achieve 10 sessions.
Intervention code [1] 290308 0
Rehabilitation
Comparator / control treatment
The CG will undergo the same exercise program and movements three times per week without resistance or progression.
Control group
Dose comparison

Outcomes
Primary outcome [1] 293229 0
Quality of Life as assessed by self-reported survey: Burn Specific Health Scale-Brief
Timepoint [1] 293229 0
6 weeks, 3 Months, and 6 Months post burn injury
Primary outcome [2] 293347 0
Quality of Life as assessed by self reported survey: Short Form-36
Timepoint [2] 293347 0
6 weeks, 3 months, 6 months post burn injury
Secondary outcome [1] 310641 0
Muscle Strength of biceps, triceps, deltoid, quadriceps, lower limb complex and grip strength as assessed by dynamometry.
Timepoint [1] 310641 0
At each exercise session, 6 weeks, 3 Months, 6 Months post burn injury.
Secondary outcome [2] 310642 0
Muscle Mass as assessed by: bioimpedence spectroscopy
Timepoint [2] 310642 0
At each exercise session, 6 Weeks, 3 Months, 6 Months post burn injury
Secondary outcome [3] 310643 0
Function as assessed by: the Timed Up and Go, active joint range of motion, Quick-DASH and Lower Limb Functional Index
Timepoint [3] 310643 0
Baseline, weekly during intervention period, 6 Weeks, 3 Months, 6 Months post burn injury
Secondary outcome [4] 310644 0
Nutritional status as assessed by: Whole body bioimpedence spectroscopy measuring phase angle at 50kHz.
Timepoint [4] 310644 0
Bioimpedence spectroscopy: baseline, weekly during intervention period, 6 weeks, 3 months, 6 months post burn injury
Secondary outcome [5] 310826 0
Nutritional Status as assessed by: serum assay of Glycated haemoglobin (HbA1c), C-Reactive Protein (CRP) & Retinol Binding Protein (RBP)
Timepoint [5] 310826 0
HbA1c: baseline, 6 weeks, 3 months, 6 months post burn injury

CRP: baseline, weekly during intervention period, 6 weeks, 3 months, 6 months post burn injury

RBP: Baseline, 6 weeks, 3 months, 6 months post burn injury

Eligibility
Key inclusion criteria
Adults (above 18 years of age) admitted to the Western Australian State Adult Burns Unit with an acute burn injury.
TBSA 5-40%.
Able to give consent within 72 hours of admission.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Discharge within 72 hours.
Burns to palmar hands.
Electrical injury.
Multi trauma or injury severe enough to warrant amputation.
Pre-existing musculoskeletal injuries excluding patients from exercising.
Type 1 diabetes or other metabolic conditions.
Neurological conditions or poor English language (requiring interpreter).
Unable to cooperate with the exercise program

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)
Recruitment will occur within the Western Australia State Adult Burns Unit. Investigators will approach appropriate patients within 72 hours of admission for consent to participate in the study.

Participants will be randomised into either control or intervention groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation based upon total burn surface area (TBSA). Patients are to be allocated to a group randomly using sealed, opaque envelopes for concealment of allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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

Recruitment
Recruitment status
Completed
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)
WA
Recruitment hospital [1] 3677 0
Fiona Stanley Hospital - Murdoch

Funding & Sponsors
Funding source category [1] 290000 0
Other Collaborative groups
Name [1] 290000 0
Raine Medical Research Foundation
Address [1] 290000 0
Suite 24, Hollywood Specialist Centre
95 Monash Avenue
Nedlands WA 6009
Country [1] 290000 0
Australia
Funding source category [2] 290001 0
Charities/Societies/Foundations
Name [2] 290001 0
Fiona Wood Foundation
Address [2] 290001 0
Fiona Stanley Hospital, Burns Outpatients, 11 Robin Warren Drive, Murdoch 6150
Country [2] 290001 0
Australia
Primary sponsor type
Individual
Name
Paul Gittings
Address
Burns Service of Western Australia
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, WA, 6150
Country
Australia
Secondary sponsor category [1] 288684 0
Individual
Name [1] 288684 0
Dale Edgar
Address [1] 288684 0
Burns Service of Western Australia
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, WA, 6150
Country [1] 288684 0
Australia
Other collaborator category [1] 278161 0
University
Name [1] 278161 0
University of Notre Dame Australia
School of Physiotherapy
Burn Injury Research Node
Address [1] 278161 0
Mouat St
Fremantle, WA, 6959
Country [1] 278161 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291708 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 291708 0
Colonial House
Royal Perth Hospital
Murray St
Perth, WA, 6000
Ethics committee country [1] 291708 0
Australia
Date submitted for ethics approval [1] 291708 0
Approval date [1] 291708 0
08/05/2014
Ethics approval number [1] 291708 0
14-008
Ethics committee name [2] 292638 0
University of Notre Dame Australia Ethic Committee
Ethics committee address [2] 292638 0
19 Mouat Street
Fremantle
WA
6959
Ethics committee country [2] 292638 0
Australia
Date submitted for ethics approval [2] 292638 0
Approval date [2] 292638 0
02/10/2014
Ethics approval number [2] 292638 0
014138F
Ethics committee name [3] 292639 0
Fiona Stanley Hospital HREC
Ethics committee address [3] 292639 0
102 - 118 Murdoch Drive
Murdoch
Western Australia
Ethics committee country [3] 292639 0
Australia
Date submitted for ethics approval [3] 292639 0
Approval date [3] 292639 0
16/03/2015
Ethics approval number [3] 292639 0
2014-099

Summary
Brief summary
It is known that survivors of burn injury often experience impairments in strength and functional ability for the rest of their life. This is a result of losses in skeletal muscle mass and strength. This study aims to investigate the effect of resistance training on the muscle mass, strength and quality of life of a burns patient.

It is expected that patients who undertake a structured resistance exercise training program will exhibit increased muscle mass, increased strength and an improved quality of life compared to the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51678 0
Mr Paul Gittings
Address 51678 0
State Adult Burns Unit
Level 4 Fiona Stanley Hospital
Locked Bag 100 Palmyra, WA 6961
Country 51678 0
Australia
Phone 51678 0
+61405771926
Fax 51678 0
Email 51678 0
paul.gittings@health.wa.gov.au
Contact person for public queries
Name 51679 0
Mr Paul Gittings
Address 51679 0
State Adult Burns Unit
Level 4 Fiona Stanley Hospital
Locked Bag 100 Palmyra, WA 6961
Country 51679 0
Australia
Phone 51679 0
+61405771926
Fax 51679 0
Email 51679 0
paul.gittings@health.wa.gov.au
Contact person for scientific queries
Name 51680 0
Mr Paul Gittings
Address 51680 0
State Adult Burns Unit
Level 4 Fiona Stanley Hospital
Locked Bag 100 Palmyra, WA 6961
Country 51680 0
Australia
Phone 51680 0
+61405771926
Fax 51680 0
Email 51680 0
paul.gittings@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary