Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000788077
Ethics application status
Approved
Date submitted
14/09/2010
Date registered
23/09/2010
Date last updated
21/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise intervention trial for women with breast cancer related lymphoedema
Scientific title
Efficacy and safety of high versus low intensity resistance exercise for management of lymphoedema in breast cancer survivors
Secondary ID [1] 252739 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoedema secondary to breast cancer 258177 0
Condition category
Condition code
Cancer 258360 258360 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progressive supervised resistance exercises (e.g. upper and lower body resistance based exercises using weight machines and free weights) and aerobic exercise (e.g. walking, cycling, rowing etc.) twice weekly (60 minute sessions) for 12 weeks. These supervised sessions will be administered by an exercise physiologist and undertaken in small groups of participants (up to 8). Participants will continue their usual care for breast cancer and lymphoedema management for the duration of the intervention.

Two experimental groups will undertake different types of exercise interventions: (1) high intensity resistance training (HIGH), and (2) low intensity resistance training (LOW). The only difference between these groups will be the intensity of the resistance exercises. For HIGH, the intensity will be manipulated from 6-10 repetition maximum (i.e. the maximal weight that can be lifted 6-10 times) using 1-3 sets per exercise. For LOW, intensity will be manipulated from 15-20 repetition maximum (i.e. the maximal weight that can be lifted 15-20 times) using 1-3 sets per exercise.
Intervention code [1] 257198 0
Treatment: Other
Intervention code [2] 257199 0
Lifestyle
Comparator / control treatment
Participants in the usual care delay exercise group will receive usual care for 12 weeks. At the completion of the usual care period participants will then receive the 12 week exercise intervention. Usual care will be determined on a case by case basis by the individuals participants oncologist and lymphoedema therapist.
Control group
Active

Outcomes
Primary outcome [1] 259208 0
Lymphoedema Status and Associated Symptoms. Lymphoedema status (i.e. the amount of swelling in the upper extremity) will be assessed using standard objective measures including bioimpedance spectroscopy, arm circumference measurements and dual energy x-ray absorptiometry. Lymphoedema associated symptoms will be assessed using a modification of the Brief Pain Inventory.
Timepoint [1] 259208 0
Baseline and at 12 weeks (post-intervention)
Secondary outcome [1] 265595 0
Muscular Strength and Endurance. Maximal strength will be assessed using one-repetition maximum tests. Maximal grip strength will be tested using an isometric dynamometer. Muscle endurance will be assessed using a repetition maximum test (i.e. the maximal number of repetitions possible with 70% of one-repetition maximum)
Timepoint [1] 265595 0
Baseline and at 12 weeks (post-intervention)
Secondary outcome [2] 265596 0
Range of Motion and Functional Ability. Range of motion around the shoulder and elbow joints will be measured for affected and non-affected limbs using standard goniometric techniques. Functional ability of the upper body will be measured using the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Functional ability of the lower body will be measured using a repeated chair rise test.
Timepoint [2] 265596 0
Baseline and at 12 weeks (post-intervention)
Secondary outcome [3] 265597 0
Quality of Life. Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) and breast cancer specific questionnaire (EORTC QLQ-BR23). The Functional Assessment of Chronic Illness Therapy B+4 (FACT-B+4) questionnaire will be utilised to specifically assess health-related quality of life for patients with breast cancer related lymphoedema.
Timepoint [3] 265597 0
Baseline and at 12 weeks (post-intervention)

Eligibility
Key inclusion criteria
Clinical diagnosis of breast cancer related lymphoedema defined as at least a 10% inter-limb discrepancy in volume or circumference at the point of greatest visible difference.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Any musculo-skeletal, cardiovascular or neurological disorder that could place the participant at risk of injury or illness resulting from the exercise.

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,WA
Recruitment postcode(s) [1] 3257 0
2617
Recruitment postcode(s) [2] 3256 0
6027

Funding & Sponsors
Funding source category [1] 257654 0
University
Name [1] 257654 0
Edith Cowan University
Country [1] 257654 0
Australia
Funding source category [2] 257655 0
University
Name [2] 257655 0
University of Canberra
Country [2] 257655 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 256871 0
University
Name [1] 256871 0
University of Canberra
Address [1] 256871 0
University Drive
Bruce ACT 2617
Country [1] 256871 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259668 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 259668 0
Ethics committee country [1] 259668 0
Australia
Date submitted for ethics approval [1] 259668 0
Approval date [1] 259668 0
09/08/2010
Ethics approval number [1] 259668 0
5443 CORMIE

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31642 0
Address 31642 0
Country 31642 0
Phone 31642 0
Fax 31642 0
Email 31642 0
Contact person for public queries
Name 14889 0
Dr Prue Cormie
Address 14889 0
Edith Cowan University Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 14889 0
Australia
Phone 14889 0
+61 8 6304 3418
Fax 14889 0
Email 14889 0
p.cormie@ecu.edu.au
Contact person for scientific queries
Name 5817 0
Dr Prue Cormie
Address 5817 0
Edith Cowan University Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 5817 0
Australia
Phone 5817 0
+61 8 6304 3418
Fax 5817 0
Email 5817 0
p.cormie@ecu.edu.au

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.