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Trial registered on ANZCTR


Registration number
ACTRN12611001158954
Ethics application status
Approved
Date submitted
3/11/2011
Date registered
4/11/2011
Date last updated
10/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomised controlled trial
Scientific title
The effect of multi-modal exercise versus usual care on physical function in prostate cancer patients with bone metastases.
Secondary ID [1] 273327 0
Nil
Universal Trial Number (UTN)
U1111-1125-6467
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 279097 0
Condition category
Condition code
Cancer 279286 279286 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise Group:
The modular multi-modal physical exercise intervention program will comprise resistance (10-12-RM), aerobic (60-85% HRmax) and flexibility exercises undertaken 3 times per week for 3 months. Participants will be reassessed again at 6 months. Exercise training sessions will take approximately 60 minutes and will be conducted in small groups of up to 6 participants under supervision of an exercise physiologist
Intervention code [1] 283676 0
Lifestyle
Comparator / control treatment
Usual Medical Care Group:
Participants will remain on their usual care for the initial 3 months, then will receive the multi-modal physical exercise intervention program will comprise resistance, aerobic and flexibility exercises undertaken 3 times per week for the second 3 months.
Control group
Active

Outcomes
Primary outcome [1] 279904 0
Physical Function: Physical function subscale of SF-36 questionnaire.
Timepoint [1] 279904 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [1] 294729 0
Measures of Physical Function: Standard measures of functional performance. 1) repeated chair rise, 2) stair climb, 3) 6-meter backward tandem walk, 4) 6-meter walk, usual and fast pace, and 5) 400-m walk
Timepoint [1] 294729 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [2] 294730 0
Balance: A Neurocom Smart Balancemaster (Neurocom, OR, USA) will be used to assess static and dynamic balance.
Timepoint [2] 294730 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [3] 294731 0
Falls self-efficacy: Activities-Specific Balance Confidence scale
Timepoint [3] 294731 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [4] 294733 0
Body Composition: Regional and whole body lean mass derived from a whole body dual-energy X-ray absorptiometry
Timepoint [4] 294733 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [5] 294734 0
Bone pain: Monitored according to the Common Terminology Criteria of the National Cancer Institute
Timepoint [5] 294734 0
Baseline, 3 months, and 6 months follow-up.
During each training session.
Secondary outcome [6] 294735 0
Muscle Density: Peripheral Quantitative Computed Tomography (pQCT) of the lower limbs
Timepoint [6] 294735 0
Baseline, 3 months, and 6 months follow-up.
Secondary outcome [7] 294736 0
Health-related Quality of Life: Measured using the SF-36 questionnaire
Timepoint [7] 294736 0
Baseline, 3 months, and 6 months follow-up.
Secondary outcome [8] 294737 0
Anxiety and Depression: The Brief Symptom Inventory-18
Timepoint [8] 294737 0
Baseline, 3 months, and 6 months follow-up.
Secondary outcome [9] 294738 0
Cancer Specific Distress: The Impact of Events Scale (IES) and the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Timepoint [9] 294738 0
Baseline, 3 months, and 6 months follow-up.
Secondary outcome [10] 294739 0
Physical Activity: Will be assessed by the Godin Leisure-Time Questionnaire, and using triaxial accelerometry
Timepoint [10] 294739 0
Baseline, 3 months, and 6 months follow-up.
Secondary outcome [11] 294740 0
Prostate Specific Antigen - Serum analysis
Timepoint [11] 294740 0
Baseline, 3 months, and 6 months follow-up.
Secondary outcome [12] 294741 0
Muscle Strength. Dynamic muscular strength of knee extension and chest press exercises using a standard 1RM protocol.
Timepoint [12] 294741 0
Baseline, 3 months, and 6 months follow-up.
Secondary outcome [13] 294742 0
Physical Activity Motivation: Theory of Planned Behaviour constructs (affective and instrumental attitude, injunctive and descriptive norm, self-efficacy, perceived behavioural control, intention, and planning) will be assessed using a standard TPB Questionnaire.
Timepoint [13] 294742 0
Baseline, 3 months, and 6 months follow-up.
Secondary outcome [14] 294743 0
Tolerance of the Program: Evaluated by recording participants' ratings of perceived exertion on a Borg scale
Timepoint [14] 294743 0
During each training session.
Secondary outcome [15] 294744 0
Nutritional Status: 3 day food diary
Timepoint [15] 294744 0
Baseline, 3 months, and 6 months follow-up.

Eligibility
Key inclusion criteria
Men with prostate cancer and established bone metastases.
Minimum age
No limit
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men participating in regular exercise (structured aerobic or resistance training two or more times per week) within the past 3 months.
Acute illness or cardiovascular/neurological disorders that could inhibit exercising.
Not ambulatory without assistance.
Current fracture, or fracture within the last 6-months

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)
Written informed consent will be required prior to any testing or randomisation. Assignments will be placed in sealed opaque envelopes and designated colours will be assigned for each group. The subject will open these envelopes after completion of all baseline testing. Subjects who dropout prior to completion of baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are randomised after the baseline assessment has been completed to: 1. Exercise training or 2. Usual care control. Randomisation is at the level of the individual patient, and will be stratified by treatment status and location of metastases. The list will be generated and maintained by a research assistant not otherwise involved in the study. The sequential treatment assignments are based on a computer-generated randomisation scheme (by using the Web site www.randomization.com set up by Dr Gerard E. Dallal).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Different groups of participants receive different interventions during the same time span of the study, however the usual care group receive the intervention during after 3 months of usual treatment.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
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,WA

Funding & Sponsors
Funding source category [1] 284157 0
Charities/Societies/Foundations
Name [1] 284157 0
Prostate Cancer Foundation of Australia
Address [1] 284157 0
P.O.Box 1332
Lane Cove NSW 1595
Country [1] 284157 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
27 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 269115 0
Individual
Name [1] 269115 0
A/Prof Daniel Galvao
Address [1] 269115 0
ECU Health and Wellness Institute
Edith Cowan University
27 Joondalup Drive
Joondalup WA 6027
Country [1] 269115 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272118 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 272118 0
270 Joondalup Drive JOONDALUP WA 6027
Ethics committee country [1] 272118 0
Australia
Date submitted for ethics approval [1] 272118 0
30/11/2011
Approval date [1] 272118 0
Ethics approval number [1] 272118 0
7699 GALV?O

Summary
Brief summary
This study aims to determine the safety and efficacy of a tailored exercise program in prostate cancer patients with bone metastases.

Who is it for?
You may be eligible to join this study if you are a man with prostate cancer with diagnosed bone metastases.

Trial details.
Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will undergo supervised exercise training. This involves resistance, aerobic (stationary cycling) and flexibility exercises, three times per week over a period of 3 months and then will be monitored (without training) for a further 3 months. The other group will be assigned to no treatment for the first 3 months. After this time participants in this group will commence the exercise program for the next 3 months.

Participants will complete some tests of physical function and questionnaires about fatigue, pain and physical activity levels, and have their body composition measured at these time points. It is thought that the exercise program will be safe and will improve physical function when compared to no training.
Trial website
http://www.ecuhealthwellnessinstitute.org/research-activity/projects/current/ecuhwi/feasibility-and-efficacy-of-resistance-exercise-in-prostate-cancer-survivors-with-bone-metastases
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33351 0
Prof Daniel Galvao
Address 33351 0
ECU Health and Wellness Institute 270 Joondalup Drive Joondalup WA 6027
Country 33351 0
Australia
Phone 33351 0
+61, 08, 6304 3420
Fax 33351 0
Email 33351 0
d.galvao@ecu.edu.au
Contact person for public queries
Name 16598 0
Prof Daniel Galvao
Address 16598 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 16598 0
Australia
Phone 16598 0
+61, 08, 6304 3420
Fax 16598 0
+61, 08, 6304 3420
Email 16598 0
d.galvao@ecu.edu.au
Contact person for scientific queries
Name 7526 0
Prof Daniel Galvao
Address 7526 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 7526 0
Australia
Phone 7526 0
+61, 08, 6304 3420
Fax 7526 0
+61, 08, 6304 2499
Email 7526 0
d.galvao@ecu.edu.au

No data has been provided for results reporting
Summary results
Not applicable