ANZCTR - Registration

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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

Condition category

Condition code

Cancer

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]

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]

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]

At baseline, 10 weeks (or following the completion of training) and 6 months following the completion of training

Secondary outcome [1]

1. Maximal isometric shoulder strength will be measured objectively using a standardised protocol.

Timepoint [1]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

RT Hall Foundation

Address [1]

Nexia court and co post office box h195 Australia square Sydney NSW 1214

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

East Street Lidcombe NSW 2141

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/10/2004

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Sharon Czerniec

Address

School of Physiotherapy
Faculty of Health Sciences
University of Sydney
C42
PO Box 170
Lidcombe NSW 1825

Country

Australia

Phone

+61 2 93519545

Fax

+61 2 93519160

S.Czerniec@fhs.usyd.edu.au

Contact person for scientific queries

Name

Dr Sharon Kilbreath

Address

School of Physiotherapy
Faculty of Health Sciences
University of Sydney
C42
PO Box 170
Lidcombe NSW 1825

Country

Australia

Phone

+61 2 93519272

Fax

+61 2 93519160

s.kilbreath@fhs.usyd.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.

Trial Review

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