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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise For Breast Cancer Patients With Lymphedema
Scientific title
High vs. Low Intensity Resistance Exercise In Breast Cancer Patients with Lymphedema: A Randomised Controlled Trial to compare effect on lymphedema status, muscle strength and functional performance
Secondary ID [1] 279958 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 285874 0
Lymphedema 285896 0
Condition category
Condition code
Cancer 286060 286060 0 0

Study type
Description of intervention(s) / exposure
Arm 1 – High-Intensity Resistance Training
Arm 2 – Low-Intensity Resistance Training
Arm 3 – Usual Care (Control)

Participants undertook combined aerobic and progressive resistance training twice a week for 12-
weeks in a supervised clinical exercise facility. Five minutes warm-up and cool-down were
performed before and after each exercise session and included light aerobic activity and stretching.
The resistance exercises included the chest press, seated row, and lateral pull down, lateral raises,
front raises, triceps extension, leg extension and abdominal crunches. The resistance exercise
program was designed to progress from 8- to 5-repetition maximum (RM) for two to four sets per
exercise for the HI group, whilst the LI exercise group progressed from 18- to 15-RM using two to
four sets per exercise. The aerobic component of the training program included 15 to 25 minutes of
cardiovascular exercises (walking/cycling/jogging) at 65% to 80% maximum heart rate and at a
perceived exertion ranging from 11 to 13 (6 to 20 point Borg Scale).
Sessions were conducted in small groups of 4-8 participants under direct supervision of an exercise
physiologist and lasted approximately 50-minutes. Patients were encouraged to maintain customary
diet intake throughout the study. The study was confined to the two training locations in Nairobi.
Intervention code [1] 284290 0
Comparator / control treatment
No treatment/exercise but rather continuation of normal daily activities and lifestyle – usual care
Control group

Primary outcome [1] 286541 0
Primary Outcome 1: lymphedema status
Lymphedema was assessed using standard volumetric arm measurements based on water
displacement and circumference measures
Timepoint [1] 286541 0
At baseline and following 12-weeks
Primary outcome [2] 286542 0
1-RM Strength
Dynamic concentric muscle strength was measured for three exercises (Chest Press, Seated Row and
Leg Extension), using the one repetition maximum (1-RM).The 1-RM being the maximal weight an individual can move through a full
range of motion without a change in body position other than that dictated by the specific exercise
Timepoint [2] 286542 0
At baseline and following 12-weeks
Primary outcome [3] 286543 0
Functional performance (repeated chair rise, 400m walk and stair climb)
Timepoint [3] 286543 0
At baseline and following 12-weeks
Secondary outcome [1] 296123 0
Cancer Specific Quality of Life using the European Organisation for Research and Treatment in Cancer (EORTC) Quality of Life Questionaire (QLQ-C30) with the breast cancer Specific Module (BR-23)
Timepoint [1] 296123 0
Baseline and following 12-weeks
Secondary outcome [2] 296124 0
Fatigue using the Multi-dimensional Fatigue Inventory
Timepoint [2] 296124 0
Baseline and following 12-weeks
Secondary outcome [3] 296125 0
Shoulder Range of Motion: Using Goniometry for flexion, abduction and horizontal extension
Timepoint [3] 296125 0
Baseline and following 12-weeks
Secondary outcome [4] 296126 0
Body Composition using Single frequency Bio-Electrical Impedence (SF-BIA)
Timepoint [4] 296126 0
Baseline and following 12-weeks

Key inclusion criteria
History of non-metastatic unilateral breast cancer
Completion of Treatment (radiotherapy and/or chemotherapy) at least 6-weeks prior to study
Secondary lymphedema
Not participated in structured exercise training in last 3-months
Minimum age
18 Years
Maximum age
100 Years
Can healthy volunteers participate?
Key exclusion criteria
Any musculoskeletal, cardiovascular, neurological or psychiatric condition that could be exacerbated by exercise or not otherwise approved by their oncologist

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was done by central randomisation by computer Following familiarisation and baseline assessments patients were randomly assigned to three arms in a 1:1:1 ratio using a computer generated program stratified by age (<50 years or >50 years) and stage of lymphedema (stages 0-I or stages II-III). Allocation sequence was concealed from the exercise physiologist involved in assigning patients to groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer
software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 4133 0
State/province [1] 4133 0

Funding & Sponsors
Funding source category [1] 284744 0
Name [1] 284744 0
Edith Cowan University
Address [1] 284744 0
100 Joondalup Drive
Western Australia 6027
Country [1] 284744 0
Primary sponsor type
Edith Cowan University
100 Joondalup Drive
Western Australia 6027
Secondary sponsor category [1] 283636 0
Name [1] 283636 0
Zoe Gibbs
Address [1] 283636 0
P.O.Box 15377,00509
Country [1] 283636 0

Ethics approval
Ethics application status
Ethics committee name [1] 286749 0
Edith Cowan University HREC
Ethics committee address [1] 286749 0
100 Joondalup Drive
Western Australia 6027
Ethics committee country [1] 286749 0
Date submitted for ethics approval [1] 286749 0
Approval date [1] 286749 0
Ethics approval number [1] 286749 0

Brief summary
Appropriate physical exercise has produced meaningful improvements in function and reduction in fatigue for a range of cancer populations but the specifics of prescription are not well established. This study examined the effects of a 12-week high-intensity (HI) versus a low-intensity (LI) resistance training protocol on body composition, lymphatic volume, physical and functional fitness, quality of life (QOL),fatigue and psychosocial functioning in breast cancer patients in Kenya.
Patients and methods
Seventy-three breast cancer survivors (mean age 53; BMI 28) with unilateral lymphedema were randomly assigned to usual care (n=31), supervised HI resistance exercise (n =31), or supervised LI resistance exercise (n=32). Outcome measures included assessments for body composition; lymphatic relative volume; muscle strength, aerobic fitness; fatigue, symptom experience, and QOL (EORTC-C30 BR-23).
Analysis of covariance was used to compare outcomes for groups at 12-weeks adjusted for baseline values and potential confounders. Both HI and LI reduced lymphatic relative volume, (HI -8.6%; LI -7.8%, p=.001) and improved muscle strength (chest press: HI +4.7kg; LI +3.8kg; seated row: (HI +9.7kg; LI +4.9kg; leg extension: HI +5.6kg; LI +3.9kg, p=.001). Aerobic fitness measured by the 400-m walk improved for both HI (-36.2 sec, p=.025) and LI (-18.9 sec, p=.004) groups compared to usual care
(p<.05). HI was also superior to LI exercise (-16.3 sec, p=.020) on the 400-m walk. General fatigue reduced by -28.2% and -25.3% for HI and LI groups, respectively (p=.001). HI and LI protocols also enhanced body image (HI +20.8%; LI +23.4%, p<05), breast (HI -9.5%; LI -10.8%, p<.05) and arm symptoms (HI -15.2%; LI -13.6%, p<.05).
We found both exercise protocols effective for improving muscle strength, physical function, lymphatic volume and symptom scales. Further, we have demonstrated for the first time that high-intensity exercise can be well tolerated and should also be considered in this population, not only for effective management of lymphedema but also improvement and preservation of function and quality of life.
Trial website
Trial related presentations / publications
Gibbs ZG, Galvao DA, Newton RU, Effects of high vs low-intensity resistance exercise on diurnal activity, fatigue and body composition in patients with breast cancer related lymphedema. Seventh State Cancer Conference. 24th March, Perth, Western Australia, Australia, 2011.

Gibbs ZG, Galvao DA, Newton RU, High vs low intensity resistance exercise in late stage breast cancer patients with lymphedema: A randomised controlled trial. Clinical Oncological Society of Australia, 38th Annual Scientific Meeting. Clinical Oncology, Volume 7, Supplement 4, 15th-17th November 2011.
Public notes

Principal investigator
Name 33775 0
Address 33775 0
Country 33775 0
Phone 33775 0
Fax 33775 0
Email 33775 0
Contact person for public queries
Name 17022 0
Zoe Gibbs
Address 17022 0
P.O. Box 15377, 00509
Country 17022 0
Phone 17022 0
+254 721969640
Fax 17022 0
Email 17022 0
Contact person for scientific queries
Name 7950 0
Zoe Gibbs
Address 7950 0
P.O. Box 15377, 00509
Country 7950 0
Phone 7950 0
+254 721969640
Fax 7950 0
Email 7950 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary