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Trial registered on ANZCTR


Registration number
ACTRN12613000665730
Ethics application status
Approved
Date submitted
11/06/2013
Date registered
19/06/2013
Date last updated
24/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of aerobic- versus resistance-based exercise on
breast cancer-related lymphoedema
Scientific title
Measuring the effects of aerobic- versus resistance-based exercise on lymphoedema status in primary breast cancer survivors with breast cancer-related lymphoedema
Secondary ID [1] 282643 0
Nil
Universal Trial Number (UTN)
U1111-1144-1562
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer-related lymphoedema 289345 0
Condition category
Condition code
Cancer 289681 289681 0 0
Breast
Physical Medicine / Rehabilitation 289744 289744 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate and compare the effects of aerobic- versus resistance-based exercise to usual care on lymphoedema, lymphoedema-related symptoms (e.g. decreased fitness, impaired functioning, changes in weight, strength loss), and quality of life. Women will be asked to participate in a 12-week intervention (or usual care) and will be assessed pre- and post-intervention and 12 weeks post-intervention.

For those in the aerobic-based exercise group, any form of aerobic activity may be undertaken, provided it is at a Rating of Perceived Exertion (RPE) of 11-13 (on a 6-20 scale) for weeks 1-6 and an RPE of 12-14 for weeks 7-12. Sessions will be conducted at location convenient to the participant. During weeks 1-4, there will be 2 supervised sessions a week (50 minutes each), with participants asked to accumulate another 50 minutes of unsupervised exercise (150 minutes total each week). For weeks 5-12, participants will receive 1 supervised session per week (50 minutes) and be asked to achieve an additional 100 minutes unsupervised.

All resistance-based exercise sessions will begin with a five-minute cardiovascular warm-up period, followed by a full-body strength training program, including: chest fly, triceps kick-back, squat, curl-ups, bent-over row, bridging, wall push-up, bicep curls, calf raises, shoulder press, external rotation and forward lunge. Modifications will be made at the research’s discretion if pain, injury or altered range of motion prevents proper technique of the given exercise. The same schedule and intensity as the aerobic-based group will be used in the resistance-based group.

To monitor adherence, participants in the aerobic- and resistance-based exercise groups will be given activity logs in which to record their weekly, unsupervised exercise, including time, modality and RPE during the session. They will also be asked to record relevant information for exercise sessions (e.g., modifications, pain/discomfort, barriers encountered). At each supervised session over the 12-week intervention, the researcher will review this log with the participant to assess adherence and address any concerns or queries that may arise. The researcher and participant will also schedule days and times during the week when the unsupervised exercise will be undertaken, with identification of an additional ‘back-up’ time period should any barriers arise during any of the selected times. As each program is supervised, this will include discussion of personal barriers and strategies to overcome them, as is traditionally done by exercise physiologists.

Verbal praise will be used when participants complete expected unsupervised exercise and given positive encouragement and advice when unsuccessful in meeting the weekly goal. Though 100% adherence is emphasised, individuals will be reminded that an overall adherence of 80%, or 1920 total minutes, over the 12 weeks is the ultimate aim, and if there are weeks they cannot obtain 150 minutes of exercise, they can make up the missed time the following week. Participants in the usual care control group will be called weekly (weeks 1-4) or fortnightly (weeks 5-12) to maintain their interest in the study and ensure they have not increased their exercise participation.
Intervention code [1] 287310 0
Rehabilitation
Intervention code [2] 287311 0
Behaviour
Comparator / control treatment
A usual care control group will be included to allow the assessment of what, if any, additional benefits are accrued by participating in aerobic- or resistance-based exercise with standard lymphoedema treatment. This 'standard treatment' group will receive a weekly phone call to monitor physical activity levels and lymphoedema symptoms and treatment, as well as to maintain study interest. Following the 24-week intervention, this group will be offered a personalised exercise program.
Control group
Active

Outcomes
Primary outcome [1] 289769 0
Presence of lymphoedema, as assessed by bioimpedance spectroscopy (BIS), arm circumference measurements, dual-energy x-ray absorptiometry (DXA) and a subjective questionnaire
Timepoint [1] 289769 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [1] 303205 0
Body composition, determined using dual-energy x-ray absorptiometry
Timepoint [1] 303205 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [2] 303206 0
Aerobic fitness, measured with a 6-minute walk test
Timepoint [2] 303206 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [3] 303207 0
Upper- and lower-body strength, measured using a squat test, YMCA bench press and push-pull and handgrip dynamometer.
Timepoint [3] 303207 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [4] 303208 0
Self-efficacy for exercise barriers, assessed with a questionnaire asking women about various barriers to exercise they may encounter (both general and lymphoedema-related) and how confident they are to overcome these.
Timepoint [4] 303208 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [5] 303209 0
Subjective upper-body function, assessed using the validated Disability of Arm, Shoulder and Hand (DASH) questionnaire, which measures the extent of disability experienced as a consequence of impaired upper-body function.
Timepoint [5] 303209 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [6] 303210 0
Quality of life, measured using the Functional Assessment of Cancer Therapy, Breast (FACT-G +breast cancer module+4)
Timepoint [6] 303210 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement

Eligibility
Key inclusion criteria
Women with a diagnosis of unilateral breast cancer-related lymphoedema following nonmetastatic breast cancer, completed all cancer-related treatments, physically capable of participating in a moderate-intensity exercise program
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to read and understand English; pregnant or may become pregnant during intervention; ECOG status of 3+; women with a cognitive impairment or mental illness; currently undertaking more than half of the exercise prescription (i.e. 75 minutes/week of moderate-intensity 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)
Randomisation will be conducted using a stratified, blocked approach, with participants allocated to the aerobic-based exercise, resistance-based exercise or usual care control group after their initial assessment. Stratification will be based on stage of lymphoedema (Stage 0/1 and 2/3). This will allow greater strength of sub-group analyses, as research has suggested stage of lymphoedema can impact the efficiency of objective measures to assess the condition and potentially the responsiveness of the
tissue to the intervention.

Once randomised number tables were generated using Microsoft Excel, two piles of sealed, non-translucent envelopes were labelled corresponding to these number tables and distributed at the end of initial assessment, depending on which group a participant was stratified into. All participant enrolment, randomisation sequence generation and group allocation was completed by the student.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Microsoft Excel was used to generate two random number tables, one for each group (Stage 0/1 versus Stage 2/3). These number tables will then be used to assign participants to one of the three groups in a random order.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All participants will undergo 12 weeks of their respective intervention (aerobic- or resistance-based exercise or usual care) and then undertake a 12-week follow-up period with no researcher contact.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculations are based on findings from previous research studies in women with breast cancer-related lymphoedema, utilising both published and unpublished data. The study is powered based on the change expected in those with later-stage, unilateral BCRL, as these are the primary participant characteristics in previous research used for sample size calculations. Values were extracted from relevant studies on expected change in lymphoedema status in the non-exercising group, assessed via BIS, circumferences or water displacement, over a 3- to 12-month period. This allowed determination of the approximate ‘normal’ change in lymphoedema status over a given time period and calculation of what would be a clinically significant reduction in lymphoedema in the aerobic- or resistance-based exercise group (greater than or equal to 10% for BIS interlimb impedance ratios or greater than or equal to 5% for circumference/water displacement interlimb difference). Also taken into account for determining sample size were considerations for scope of a PhD, based on recruitment feasibility and time requirements. A conservative total sample size of 48 participants will provide 80% power to test equivalence, allowing for a combined 20% attrition and non-compliance/contamination rate, based on a two-sided test with a significance level of 0.05.

Data will be analysed on an intention-to-treat basis utilising the last results obtained and including all participants completing baseline measurements, regardless of compliance. Primary analyses will test the equivalence hypothesis that lymphoedema status will not significantly change in any of the three study groups. A one-way ANOVA will be used to determine between- and within-group differences in lymphoedema status, as measured by objective and subjective methods. Changes in secondary outcomes will be assessed using one-way ANOVAs. For both primary and secondary outcomes, appropriate post-hoc tests will be run when ANOVA results reveal significant between-group differences for an outcome variable. General linear models or similar techniques deemed appropriate will be used to adjust for baseline characteristics such as age, gender and body mass index if necessary.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2013
Actual
20/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1098 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 287423 0
University
Name [1] 287423 0
Queensland University of Technology
Country [1] 287423 0
Australia
Primary sponsor type
Individual
Name
Jena Buchan
Address
School of Public Health and Social Work
O Block, A wing
QUT, Kelvin Grove Campus
GPO Box 2434
Brisbane QLD 4001
Country
Australia
Secondary sponsor category [1] 286171 0
Individual
Name [1] 286171 0
Associate Prof. Sandi Hayes
Address [1] 286171 0
School of Public Health and Social Work
O Block, A wing
QUT, Kelvin Grove Campus
GPO Box 2434
Brisbane QLD 4001
Country [1] 286171 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289404 0
QUT University Human Research Ethics Committee
Ethics committee address [1] 289404 0
Ethics committee country [1] 289404 0
Australia
Date submitted for ethics approval [1] 289404 0
Approval date [1] 289404 0
02/05/2013
Ethics approval number [1] 289404 0
1300000103

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

Contacts
Principal investigator
Name 40634 0
Ms Jena Buchan
Address 40634 0
School of Public Health and Social Work
O Block, A wing
QUT, Kelvin Grove Campus
GPO Box 2434
Brisbane QLD 4001
Country 40634 0
Australia
Phone 40634 0
+61731385677
Fax 40634 0
Email 40634 0
jena.buchan@qut.edu.au
Contact person for public queries
Name 40635 0
Jena Buchan
Address 40635 0
School of Public Health and Social Work
O Block, A wing
QUT, Kelvin Grove Campus
GPO Box 2434
Brisbane QLD 4001
Country 40635 0
Australia
Phone 40635 0
+61731385677
Fax 40635 0
Email 40635 0
jena.buchan@qut.edu.au
Contact person for scientific queries
Name 40636 0
Jena Buchan
Address 40636 0
School of Public Health and Social Work
O Block, A wing
QUT, Kelvin Grove Campus
GPO Box 2434
Brisbane QLD 4001
Country 40636 0
Australia
Phone 40636 0
+61731385677
Fax 40636 0
Email 40636 0
jena.buchan@qut.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.