Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000435583
Ethics application status
Approved
Date submitted
22/09/2006
Date registered
11/10/2006
Date last updated
19/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise for women with lymphoedema
Scientific title
A randomised trial to evaluate the effect of resistance training on volume of lymphoedema for women with
lymphoedema secondary to breast cancer.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women with unilateral upper limb lymphoedema following breast cancer surgery 1407 0
Condition category
Condition code
Cancer 1502 1502 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise group: women will attend 3 times a week for 10 weeks to be instructed in a resistance training program aimed at improving upper limb muscle strength.Each session will last approximately 60 minutes.
Intervention code [1] 1373 0
Rehabilitation
Comparator / control treatment
Control Group: will be requested to attend weekly for 10 weeks for an assessment of their lymphoedema. This assessment will take approximately 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 2073 0
Change in upper limb composition. Multi frequency bio-impedance (MFBIA) will be used to identify changes in tissue density, and in particular, extracellular fluid. In addition, measures of limb volume will be undertaken using a perometer and arm circumference measures with a tape measure.
Timepoint [1] 2073 0
At baseline, 10 weeks (or following the completion of training) and 6 months following the completion of training
Secondary outcome [1] 3581 0
1. Maximal isometric shoulder strength will be measured objectively using a standardised protocol.
Timepoint [1] 3581 0
Measures will be taken at baseline, 10 weeks (or following the completion of training) and 6 months following the completion of training.
Secondary outcome [2] 3582 0
2. Quality of Life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3 (QLQ-C30), a 30 item survey specific to cancer patients in conjunction with Breast Module (BR23), a 23 item survey specific to women with breast cancer.
Timepoint [2] 3582 0
Measures will be taken at baseline, 10 weeks (or following the completion of training) and 6 months following the completion of training.

Eligibility
Key inclusion criteria
Have had unilateral surgery for breast cancer* have completed treatment for breast cancer at least 6 months ago* have unilateral upper limb lymphoedema* have had lymphoedema present for at least 6 months* finished treatment for lymphoedema at least 1 month ago* are willing to attend training and follow-up sessions* are willing to be randomised into either treatment group.* are able to understand written and spoken english.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Have metastatic cancer* have a pacemaker or other inbuilt stimulator* are pregnant* have a previous fracture, undergpne surgery in the upper limbs or suffer any neurological deficit or other injury to either upper limb that may interfere with test procedures.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The assessor will be blinded at the 10 week and 6 month measures
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 1637 0
Charities/Societies/Foundations
Name [1] 1637 0
RT Hall Foundation
Country [1] 1637 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
East Street Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 1444 0
None
Name [1] 1444 0
Address [1] 1444 0
Country [1] 1444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3082 0
University of Sydney Ethics Committee
Ethics committee address [1] 3082 0
Ethics committee country [1] 3082 0
Australia
Date submitted for ethics approval [1] 3082 0
Approval date [1] 3082 0
02/10/2004
Ethics approval number [1] 3082 0
11-2004/4/7885

Summary
Brief summary
This is a study on the benefits of exercise for women with lymphoedema.

Who is it for?

You can join this study if you have arm swelling following breast cancer treatment, whether this is induced by surgery or radiotherapy.

Trial details

Participants will be randomly divided into two groups. One group will attend a 60 minutes exercise program three times a week for 10 weeks, aimed at improving upper limb strength The other group will asked to attend for a 30 minute assessment of their lymphoedema each week for 10 weeks (the control group will not have an exercise program). Both groups will have their lymphoedema assessed each week for 10 weeks. The trial looks at any change in upper limb composition measured using a technique known as multifrequency bio-impedance (which is a way to measure tissue density, particularly the amount of fluid in the arm) and arm circumference at 10 weeks and 6 months following completion of treatment.

There is no standard intervention recommended for women with arm swelling. The trial will determine the effects of vigorous supervised resistance training on arm lymphoedema. The trial will document whether women with lymphoedema can use their affected arm in vigorous exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27600 0
Address 27600 0
Country 27600 0
Phone 27600 0
Fax 27600 0
Email 27600 0
Contact person for public queries
Name 10562 0
Sharon Czerniec
Address 10562 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
C42
PO Box 170
Lidcombe NSW 1825
Country 10562 0
Australia
Phone 10562 0
+61 2 93519545
Fax 10562 0
+61 2 93519160
Email 10562 0
[email protected]
Contact person for scientific queries
Name 1490 0
Dr Sharon Kilbreath
Address 1490 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
C42
PO Box 170
Lidcombe NSW 1825
Country 1490 0
Australia
Phone 1490 0
+61 2 93519272
Fax 1490 0
+61 2 93519160
Email 1490 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.