Trial Review

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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] 279958 0
nil
Universal Trial Number (UTN)
Nil
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
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] 284290 0
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] 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
motion
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

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?
No
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] 4133 0
Kenya
State/province [1] 4133 0
NAIROBI

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

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286749 0
Edith Cowan University HREC
Ethics committee address [1] 286749 0
Ethics committee country [1] 286749 0
Australia
Date submitted for ethics approval [1] 286749 0
31/03/2009
Approval date [1] 286749 0
22/05/2009
Ethics approval number [1] 286749 0
3698

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

Contacts
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
Nairobi
Country 17022 0
Kenya
Phone 17022 0
+254 721969640
Fax 17022 0
Email 17022 0
[email protected]
Contact person for scientific queries
Name 7950 0
Zoe Gibbs
Address 7950 0
P.O. Box 15377, 00509
Nairobi
Country 7950 0
Kenya
Phone 7950 0
+254 721969640
Fax 7950 0
Email 7950 0
[email protected]

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.