Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000729224
Ethics application status
Approved
Date submitted
18/08/2009
Date registered
24/08/2009
Date last updated
22/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise intervention for prostate cancer patients from the RADAR study.
Scientific title
The effect of an exercise intervention on cardiovascular and metabolic risk factors in prostate cancer patients from the RADAR study
Secondary ID [1] 252935 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 243496 0
Condition category
Condition code
Cancer 239798 239798 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise: progressive supervised aerobic (e.g. walking and cycling) and resistance exercises (e.g. upper and lower body resistance based exercise using weight machines) twice weekly (60 minute sessions) for 6 months. The training will be supplemented with a printed booklet containing general information about physical activity.
Intervention code [1] 237116 0
Treatment: Other
Comparator / control treatment
Control: 6 month usual care group. All participants in this group will be provided with a printed booklet with general information about physical activity.
Control group
Active

Outcomes
Primary outcome [1] 240569 0
Aerobic capacity will be measured by subjects completing a timed 400 meters corridor walking test, which consisted of 10 laps out and back over a 20-meter course, as fast as they can at a pace they can maintain over the distance. The 400 meters walk has been shown to be a valid test to estimate aerobic capacity and walking endurance in older adults.
Timepoint [1] 240569 0
Baseline, end of intervention post-test (6 months), and at 6 months after the end of the study.
Primary outcome [2] 240629 0
Blood metabolic biomarkers: insulin, lipid profile, glucose and glycosylated hemoglobin levels will be measured commercially by accredited Australian National Association of Testing Authorities (NATA) and International Accreditation New Zealand (IANZ) laboratories.
Timepoint [2] 240629 0
Baseline, end of intervention post-test (6 months), and at 6 months after the end of the study.
Primary outcome [3] 240630 0
Abdominal obesity: central adiposity will be assessed by waist circumference and hip circumference will also be determined using anthropometric measures.
Timepoint [3] 240630 0
Baseline, end of intervention post-test (6 months), and at 6 months after the end of the study.
Secondary outcome [1] 257191 0
Body mass index (BMI) will be calculated using the measurements of height and weight.

Additionally body composition (lean and fat mass) derived from Dual energy X-ray Absorptiometry (DXA) whole body scan will be measured for the participants in the Western Australia (Perth) cohort.
Timepoint [1] 257191 0
Baseline, end of intervention post-test (6 months), and at 6 months after the end of the study.
Secondary outcome [2] 257192 0
Balance and risk of falling will be determined using the activities-specific balance scale.

Additionally, participants from Western Australia (Perth) cohort will be tested on the Neurocom Smart Balancemaster system to measure static and dynamic balance.
Timepoint [2] 257192 0
Baseline, end of intervention post-test (6 months), and at 6 months after the end of the study.
Secondary outcome [3] 257263 0
Lower body physical function will be tested using a repeated chair rise test.

Additionally, the participants in the Western Australia (Perth) cohort will be tested for maximum muscle strength using the one repitition maximum (1-RM) method. 1-RM will be assessed for leg-press, chest press. seated row and leg extension.
Timepoint [3] 257263 0
Baseline, end of intervention post-test (6 months), and at 6 months after the end of the study.
Secondary outcome [4] 257264 0
Quality of life and psychological distress will be assessed using the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer, Prostate Specific Module (EORTC QLQ-PR25), Medical Outcomes Study Short-Form 36 (SF-36v2), and The Brief Symptom Inventory-18 (BSI-18).
Timepoint [4] 257264 0
Baseline, end of intervention post-test (6 months), and at 6 months after the end of the study.

Eligibility
Key inclusion criteria
Participants enrolled in the existent Randomised Androgen Deprivation and Radiotherapy trial (RADAR study) (ACTRN12607000097448) from the sites of Perth, Newcastle (Australia) and Wellington (New Zealand).
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) metastatic bone disease; and 2) presence of muscoloskeletal, neurological or cardiovascular disorders that may inhibit participants from exercising.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 2030 0
2300
Recruitment postcode(s) [2] 2033 0
6050
Recruitment postcode(s) [3] 2034 0
6009
Recruitment postcode(s) [4] 2035 0
6210
Recruitment postcode(s) [5] 2036 0
6164
Recruitment postcode(s) [6] 2037 0
6260
Recruitment postcode(s) [7] 2038 0
6027
Recruitment outside Australia
Country [1] 1951 0
New Zealand
State/province [1] 1951 0
Wellington

Funding & Sponsors
Funding source category [1] 237503 0
Charities/Societies/Foundations
Name [1] 237503 0
Prostate Cancer Foundation of Australia
Country [1] 237503 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup, WA, 6027
Country
Australia
Secondary sponsor category [1] 236982 0
Individual
Name [1] 236982 0
Professor Robert Newton
Address [1] 236982 0
270 Joondalup Drive
Joondalup, WA, 6027
Country [1] 236982 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243623 0
Edith Cowan Human Research Ethics Committee
Ethics committee address [1] 243623 0
270 Joondalup Drive
Joondalup, WA, 6027
Ethics committee country [1] 243623 0
Australia
Date submitted for ethics approval [1] 243623 0
Approval date [1] 243623 0
13/04/2009
Ethics approval number [1] 243623 0
3636 Galvao

Summary
Brief summary
This study looks if supervised physical exercise is useful in reducing side effects of hormonal therapy for prostate cancer.

Who is it for?
You can join this study if you have been enrolled in the Randomised Androgen Deprivation and Radiotherapy (RADAR) study.

Trial details:
Participants will be divided into two groups. One group will undertake supervised resistance and aerobic exercise. Sessions are 60 minutes each, twice weekly over 6 months. The other group will be provided with a printed booklet with general information about physical exercise. The study will measure aerobic capacity, abdominal obesity, lipid and glycemic control, muscle function and other indicators of well-being before, immediately after the program and 6 months after the program. The use of androgen deprivation therapy (ADT) is accompanied by a number of side effects. This study will investigate the effects of supervised physical exercise on reversing ADT related side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30041 0
Address 30041 0
Country 30041 0
Phone 30041 0
Fax 30041 0
Email 30041 0
Contact person for public queries
Name 13288 0
Dr Daniel Galvão
Address 13288 0
School of Exercise, Biomedical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup, WA
6027
Country 13288 0
Australia
Phone 13288 0
+61 8 6304 3420
Fax 13288 0
Email 13288 0
[email protected]
Contact person for scientific queries
Name 4216 0
Dr Daniel Galvão
Address 4216 0
School of Exercise, Biomedical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup, WA
6027
Country 4216 0
Australia
Phone 4216 0
+61 8 6304 3420
Fax 4216 0
Email 4216 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
SourceTitleYear of PublicationDOI
EmbaseA multicentre year-long randomised controlled trial of exercise training targeting physical functioning in men with prostate cancer previously treated with androgen suppression and radiation from TROG 03.04 radar.2014https://dx.doi.org/10.1016/j.eururo.2013.09.041
Dimensions AIA randomized controlled trial of an exercise intervention targeting cardiovascular and metabolic risk factors for prostate cancer patients from the RADAR trial2009https://doi.org/10.1186/1471-2407-9-419
N.B. These documents automatically identified may not have been verified by the study sponsor.