Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000444088
Ethics application status
Approved
Date submitted
24/05/2010
Date registered
1/06/2010
Date last updated
1/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving lower limb function in patients with major muscular loss or denervation following resection of a sarcoma.
Scientific title
The effect of a 4 stage rehabilitation programme on lower limb physical function in patients with major muscular loss or denervation following resection of a sarcoma
Secondary ID [1] 251847 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with a previous malignancy diagnosis, with major muscular loss, damage to either Sciatic or Femoral nerves, following limb salvage surgery. 257447 0
Condition category
Condition code
Cancer 257592 257592 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be required to attend the Hollywood Functional Rehabilitation Clinic 3 times per week, for 1.5 hours. The rehabilitation intervention is for twelve weeks and will be fully supervised by an Accredited Exercise Physiologist (Miss Chrissie Mavros).

The rehabilitation intervention consists of four stages, with the ultimate goal of restoring function of the affected limb to 80% of the unaffected limb, or aged matched population from published normative data.

Stage 1 aims (wks 1-2): restoring hip, knee and ankle range of motion (ROM); re-activating and recruiting the appropriate lower limb muscles; introducing cardiovascular exercises.

Stage 2 aims (wks 3-5): strengthening the lower limb musculature; introducing core stability; further developing cardio-vascular fitness.

Stage 3 aims (wks 6-8): develop lower limb muscle strength simulating functional tasks.

Stage 4 aims (wks 9-12): restore and improve physical function during all activities of daily living.
Intervention code [1] 256540 0
Rehabilitation
Comparator / control treatment
Control is each patients contra-lateral limb (ie the unaffected limb, which does not undergo rehabilitation)
Control group
Active

Outcomes
Primary outcome [1] 258510 0
To improve the physical and psychological function of patients.

This is going to be assessed through 5 tools:
1) The six minute walk test: which measures functional ambulation capacity
2) the up and go test: also measures physical function
3) The Toronto Extremity Salvage Score: is a self administered questionnaire specific for limb salvage patients. It measures physical function and describes changes over time
4) The short-form 36 question: measures mental and health dimension (self-administered questionnaire)
5) High mobility assessment tool: assesses uni-dimensional function through various physical tests.
Timepoint [1] 258510 0
2 baseline tests (administered 2 weeks apart). If these two tests are not within 10% of each other a third baseline test will be administered. If this test is not within 10% of the second baseline test, the patient will be omitted due to instability in their results; 12 weeks (this will occur the week following the last rehabilitation session)
Secondary outcome [1] 264315 0
Secondary outcomes is lower limb muscle strength.

Muscle strength is made up of four components:
- Knee flexion/extension: will be measured by an isokinetic dynamometer
- Hip flexion/extension: will be measured isotonically via a 3repetition maximum protocol
- Hip abduction: will be measured isotonically via a 3repetition maximum protocol
- plantar flexion: will be measured isometrically via a cable tensiometer.
Timepoint [1] 264315 0
2 baseline tests (administered 2 weeks apart). If these two tests are not within 10% of each other a third baseline test will be administered. If this test is not within 10% of the second baseline test, the patient will be omitted due to instability in their results; 12 weeks (this will occur the week following the last rehabilitation session)
Secondary outcome [2] 264373 0
Joint range of motion.

Hip Flexion/Extension will be measured by a bubble inclinometer, knee flexion/extension and ankle plantar-flexion will be measured by a goniometer.
Timepoint [2] 264373 0
2 baseline tests (administered 2 weeks apart). If these two tests are not within 10% of each other a third baseline test will be administered. If this test is not within 10% of the second baseline test, the patient will be omitted due to instability in their results; 12 weeks (this will occur the week following the last rehabilitation session)

Eligibility
Key inclusion criteria
- last cancer treatment >6months
- estimated life expectancy >12months
- an indication for rehabilitation
- must live in Perth metropolitan area
- must speak and read english competently
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- presence of severe cardiovascular disease
- cognitive disturbances that may interfere with participation in the rehabilitation programme
- serious psychopathology and emotional instability that may impede participation.
- Formal rehabilitation in the last 3months

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)
Only patients of Professor David Wood and Dr Richard Carey Smith will be recruited for the study. Patients will be sent a subject information sheet and an expression of interest form from their orthopaedic surgeon, with contact details of the study coordinator.

Each patient will receive the rehabilitation intervention, with their contra-lateral limb acting as their own control
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Specifically this is a repeated measures design
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 257035 0
University
Name [1] 257035 0
The University Of Western Australia; School of Sports Science, Exercise and Health
Country [1] 257035 0
Australia
Primary sponsor type
University
Name
The University Of Western Australia; School of Sports Science, Exercise and Health
Address
The University of Western Australia,
35 Stirling Highway
Crawley, WA, 6009,
Perth, Australia
Country
Australia
Secondary sponsor category [1] 256294 0
None
Name [1] 256294 0
N/A
Address [1] 256294 0
N/A
Country [1] 256294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259048 0
The University of Western Australia (UWA) ethics committee
Ethics committee address [1] 259048 0
Ethics committee country [1] 259048 0
Australia
Date submitted for ethics approval [1] 259048 0
25/04/2010
Approval date [1] 259048 0
07/05/2010
Ethics approval number [1] 259048 0

Summary
Brief summary
This study looks at how supervised exercise programs can help in rehabilitating people with a major loss of muscle or nerves following surgery for sarcoma.

Who is it for?
You can join this study if you are recovering from a major loss of muscles or nerves after surgery for sarcoma.

Trial details
Participants will take part in a 12 week supervised rehabilitation program with exercises, 3 times per week, for 1.5 hours. The opposite unaffected limb is not used in the exercise program, and is monitored for comparison. Five tools will be used to monitor the psychological and physiological wellbeing of patients. The ultimate goal is to restore function of the affected limb to 80% of the unaffected limb,
The study aims to see how well exercise is tolerated, and how effective exercises are at increasing muscle strength and mobility, and also quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31212 0
Address 31212 0
Country 31212 0
Phone 31212 0
Fax 31212 0
Email 31212 0
Contact person for public queries
Name 14459 0
Chrissie Mavros
Address 14459 0
1 Bay Road, Claremont, WA, 6010
Country 14459 0
Australia
Phone 14459 0
+61 423 5155 99
Fax 14459 0
Email 14459 0
[email protected]
Contact person for scientific queries
Name 5387 0
Chrissie Mavros
Address 5387 0
1 Bay Road, Claremont, WA, 6010
Country 5387 0
Australia
Phone 5387 0
+61 423 5155 99
Fax 5387 0
Email 5387 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.