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Trial registered on ANZCTR
Registration number
ACTRN12615000561583
Ethics application status
Approved
Date submitted
20/04/2015
Date registered
1/06/2015
Date last updated
1/06/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of short-term exercise on breast cancer survivor
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Scientific title
Effects of short-term exercise on breast cancer survivor: Implication towards health and fitness recovery after chemotherapy and postoperative radiotherapy. A pilot study
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Secondary ID [1]
286560
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None
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Universal Trial Number (UTN)
U1111-1169-4390
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
295083
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0
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Breast
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Physical Medicine / Rehabilitation
295209
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Eleven female breast cancer survivors (age = 41 – 62 years old) who had completed chemotherapy and postoperative radiotherapy treatment performed Resistance Band Exercise (RBE) for strength training and Aerobic Zumba Dance (AZD) for cardiovascular training for six weeks. Participants took part in RBE (eight exercises for chest, arms, legs, back and abdominal) three times a week for 30 minutes per session and AZD 60 minutes once a week per session. Both RBE and AZD were conducted in a group. RBE is conducted by exercise physiologist including me and AZD is conducted by a dance instructor. Pre and post measurement on VO2 (ml/kg/min), knee and shoulder peak torque (N-m) and BIA including BMI, Skeletal Muscle Mass (SMM), percent body fat (PBF) and waist to hip ratio (WHR) were measured.
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Intervention code [1]
291665
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Treatment: Other
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Intervention code [2]
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Rehabilitation
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Comparator / control treatment
No control
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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aerobic outcomes was measured using Hur – Monark 939E cycle ergometer to determine VO2 peak values (ml/kg/min). The Astrand 6 minute sub-maximal test protocol was used.
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Assessment method [1]
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Timepoint [1]
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6 weeks
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Secondary outcome [1]
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Strength outcomes was measured using The Biodex Multi-Joint System Pro dynamometer to determine lower and upper body peak torque (N-m) of the quadriceps and hamstrings; shoulders internal and external muscle. The test protocols used were isokinetic unilateral knee extension/flexion at 90/90o.s-1 (low velocity) with contraction CON/CON and unilateral shoulder internal/external rotation at 90/90o.s-1 (low velocity) with contraction CON/CON.
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Assessment method [1]
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Timepoint [1]
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6 weeks
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Secondary outcome [2]
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This is a composite secondary outcome which includes Body mass indeks (BMI), skeletal muscle mass (SMM), % body fat (PBF) & waist hip ratio were measured using Body impedance analysis (BIA) machine.
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Assessment method [2]
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Timepoint [2]
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6 weeks
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Eligibility
Key inclusion criteria
Physically Active Breast cancer survivors who has completed their treatment. There are no restrictions with respect to completion of the therapy.
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Minimum age
40
Years
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Maximum age
65
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Non breast cancer survivors
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
none
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
none
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Data was analysed using SPSS version 20. Descriptive statistics (means and standard deviations) were calculated for all variables. Statistical significance levels for all comparisons was set a priori of alpha=0.05. Paired sample-test was used to analyse pre and post mean difference with 95% CI for outcome changes. Health and fitness levels were determined based on VO2 peak values index for Astrand protocol. VO2 peak values index for healthy sedentary individuals are = >37ml/kg/min.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/06/2014
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Actual
7/06/2014
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Date of last participant enrolment
Anticipated
30/09/2014
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Actual
20/12/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Malaysia
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State/province [1]
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Kuala Lumpur
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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HIR research grant, university Malaya
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Address [1]
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HIR University Malaya, Lembah Pantai, 50603 Kuala Lumpur
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Country [1]
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Malaysia
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Primary sponsor type
University
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Name
Malaysian breast cancer cohort (MyBcc), University Malaya
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Address
HIR University Malaya, Lembah Pantai, 50603 Kuala Lumpur
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Country
Malaysia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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University Malaya medical centre (UMMC)
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Address [1]
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University Malaya Medical Centre, Lembah Pantai 50603, Kuala Lumpur, Malaysia
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Country [1]
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Malaysia
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Abstract Purpose: To examine the effects of short term resistance band exercise (RBE) with aerobic Zumba dance (AZD) on breast cancer survivors’ health and fitness recovery after completion of their adjuvant chemotherapy and postoperative radiotherapy. Methods: Eleven female breast cancer survivors (age = 41 – 62 years old) who had completed chemotherapy and postoperative radiotherapy treatment performed RBE for strength training and AZD for cardiovascular training for six weeks. Participants took part in RBE (eight exercises for chest, arms, legs, back and abdominal) three times a week and AZD 60 minutes once a week. Pre and post measurement on VO2 (ml/kg/min), knee and shoulder peak torque (N-m) and BIA including BMI, Skeletal Muscle Mass (SMM), percent body fat (PBF) and waist to hip ratio (WHR) were measured. Results: Improvements were found in VO2peak = 9.9 +/- 17.6% (p > 0.05), SMM = 2 +/- 7.54% (p > 0.05), BMI reduced 0.49 +/- 1.1 points (p > 0.05), PBF reduced 1.8 +/- 5.22% (p > 0.05) and WHR reduced 0.1 point ratio, lower body (Knee) peak N-m showed improvements in both extension 3.67 +/- 14.04% (p > 0.05) and flexion 3.63 +/- 2.22% (p > 0.05) and upper body (Shoulder) peak N-m showed no improvements in external and internal rotation. Conclusion: This pilot study suggests that six weeks of AZD programme can improve health and fitness recovery in breast cancer survivors. RBE can be used initially for reconditioning upper and lower body strength. Practical Implication: AZD and RBE can improve recovery in lower body strength and cardiovascular health and fitness. However, longer training is needed to improve upper body strength, especially involving the shoulder, in breast cancer survivors.
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Trial website
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Trial related presentations / publications
The trial has been completed however this study is undergoing publication process.
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Public notes
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Contacts
Principal investigator
Name
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Mr Gabriel Lingesh
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Address
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University Malaya Medical Centre, Lembah Pantai 50603, Kuala Lumpur, Malaysia
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Country
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Malaysia
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Phone
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+60174349709
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Gabriel Lingesh
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Address
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University Malaya Medical Centre, Lembah Pantai 50603, Kuala Lumpur, Malaysia
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Country
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Malaysia
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Phone
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+60174349709
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Gabriel lingesh
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Address
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University Malaya Medical Centre, Lembah Pantai 50603, Kuala Lumpur, Malaysia
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Country
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Malaysia
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Phone
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+60174349709
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Fax
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Email
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[email protected]
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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.
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