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Trial registered on ANZCTR

Registration number

ACTRN12612000256875

Ethics application status

Approved

Date submitted

20/02/2012

Date registered

1/03/2012

Date last updated

1/03/2012

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]

nil

Universal Trial Number (UTN)

Nil

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast Cancer

Lymphedema

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Interventional

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]

Rehabilitation

Comparator / control treatment

No treatment/exercise but rather continuation of normal daily activities and lifestyle – usual care

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome 1: lymphedema status
Lymphedema was assessed using standard volumetric arm measurements based on water
displacement and circumference measures

Timepoint [1]

At baseline and following 12-weeks

Primary outcome [2]

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
motion

Timepoint [2]

At baseline and following 12-weeks

Primary outcome [3]

Functional performance (repeated chair rise, 400m walk and stair climb)

Timepoint [3]

At baseline and following 12-weeks

Secondary outcome [1]

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]

Baseline and following 12-weeks

Secondary outcome [2]

Fatigue using the Multi-dimensional Fatigue Inventory

Timepoint [2]

Baseline and following 12-weeks

Secondary outcome [3]

Shoulder Range of Motion: Using Goniometry for flexion, abduction and horizontal extension

Timepoint [3]

Baseline and following 12-weeks

Secondary outcome [4]

Body Composition using Single frequency Bio-Electrical Impedence (SF-BIA)

Timepoint [4]

Baseline and following 12-weeks

Eligibility

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

Sex

Females

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

Treatment

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

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

12/08/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment outside Australia

Country [1]

Kenya

State/province [1]

NAIROBI

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

100 Joondalup Drive
Perth
Western Australia 6027

Country [1]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

100 Joondalup Drive
Perth
Western Australia 6027

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Zoe Gibbs

Address [1]

P.O.Box 15377,00509
Nairobi

Country [1]

Kenya

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Edith Cowan University HREC

Ethics committee address [1]

100 Joondalup Drive
Perth
Western Australia 6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/03/2009

Approval date [1]

22/05/2009

Ethics approval number [1]

3698

Summary

Brief summary

Purpose
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).
Results
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).
Conclusion
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

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Zoe Gibbs

Address

P.O. Box 15377, 00509
Nairobi

Country

Kenya

Phone

+254 721969640

Fax

zoe.gibbs@gmail.com

Contact person for scientific queries

Name

Zoe Gibbs

Address

P.O. Box 15377, 00509
Nairobi

Country

Kenya

Phone

+254 721969640

Fax

zoe.gibbs@gmail.com

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

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