Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000082808
Ethics application status
Approved
Date submitted
16/01/2012
Date registered
17/01/2012
Date last updated
31/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Whole-Body Vibration Treatment in Prostate Cancer Survivors on Androgen Suppression Therapy
Scientific title
The Effect of Whole-Body Vibration Treatment on Bone Metabolism in Prostate Cancer Survivors who are undergoing Androgen Suppression Therapy
Secondary ID [1] 279735 0
Nil
Universal Trial Number (UTN)
U1111-1127-2072
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 285580 0
Osteopenia 285581 0
Condition category
Condition code
Cancer 285774 285774 0 0
Prostate
Musculoskeletal 285787 285787 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whole body vibration therapy (using a vibration device), 20 minutes, three times per week for 12 weeks. Vibration will be at 32-37Hz, 0.85mm peak-to-peak displacement, and at a magnitude of 0.3g.
Intervention code [1] 284032 0
Treatment: Devices
Intervention code [2] 284033 0
Prevention
Comparator / control treatment
No treatment The control group will be offered the intervention after completion of the 12 week trial.
Control group
Active

Outcomes
Primary outcome [1] 286293 0
Marker of bone formation - Serum Type 1 Procollagen N-terminal Propeptide (P1NP)
Timepoint [1] 286293 0
Baseline and after 12-weeks of intervention
Primary outcome [2] 286294 0
Marker of bone resorption - Urine analysis of N-telopeptide X/Creatinine (NTx/Cr)
Timepoint [2] 286294 0
Baseline and after 12-weeks of intervention
Secondary outcome [1] 295550 0
Fatigue - FACIT Fatigue Scale
Timepoint [1] 295550 0
Baseline and after 12-weeks of intervention
Secondary outcome [2] 295551 0
Physical Activity Levels - Godin Questionnaire, and sedentary time via domain specific sedentary questionnaire
Timepoint [2] 295551 0
Baseline and after 12-weeks of intervention
Secondary outcome [3] 295552 0
Body Composition - Dual-energy X-ray absorptiometry
Timepoint [3] 295552 0
Baseline and after 12-weeks of intervention
Secondary outcome [4] 295553 0
Physical functioning, 400m walk, static balance, stair climb, repeated chair rise, 6 meter walking tests
Timepoint [4] 295553 0
Baseline and after 12-weeks of intervention
Secondary outcome [5] 295554 0
Upper and Lower Body Strength - 1 Repetition Maximum assessment of chest press and leg press
Timepoint [5] 295554 0
Baseline and after 12-weeks of intervention
Secondary outcome [6] 295555 0
Serum 25-OH vitamin D status, testosterone levels, prostate specific antigen levels
Timepoint [6] 295555 0
Baseline and after 12-weeks of intervention
Secondary outcome [7] 295556 0
Quality of life measured by SF-36, and prostate specific concerns measured by The Expanded Prostate Cancer Index Composite Short Form
Timepoint [7] 295556 0
Baseline and after 12-weeks of intervention

Eligibility
Key inclusion criteria
Undergoing androgen suppression therapy for prostate cancer
and are within one year of initiation of treatment.
Willing to continue taking any bone altering medications or supplements they were previously taking for the duration of the study, including calcium and vitamin D.
Able to stand unassisted for sustained periods of time (i.e. 20 minutes)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Currently taking bisphosphonate medication;
Cognitive impairment;
Contraindications to vibration platform training (including pacemaker and fracture within the past six months);
Diagnosis of bone metastasis;
Diagnosis of diseases other than osteoporosis affecting bone

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. Vibration training or 2. Wait-list control. Randomisation is at the level of the individual patient, and will be stratified by age, currently taking calcium or vitamin D, current exercise status. 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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 284517 0
Charities/Societies/Foundations
Name [1] 284517 0
Australian Unity Foundation Heritage Fellowship
Country [1] 284517 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup, WA
6027
Country
Australia
Secondary sponsor category [1] 283446 0
Individual
Name [1] 283446 0
Dr. Carolyn Peddle-McIntyre
Address [1] 283446 0
270 Joondalup Drive
Joondalup, WA
6027
Country [1] 283446 0
Australia
Other collaborator category [1] 260448 0
Individual
Name [1] 260448 0
Dr. Michael Baker
Address [1] 260448 0
270 Joondalup Drive
Joondalup, WA
6027
Country [1] 260448 0
Australia
Other collaborator category [2] 260449 0
Individual
Name [2] 260449 0
A/Prof Daniel Galvao
Address [2] 260449 0
270 Joondalup Drive
Joondalup, WA
6027
Country [2] 260449 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286502 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 286502 0
Ethics committee country [1] 286502 0
Australia
Date submitted for ethics approval [1] 286502 0
01/12/2011
Approval date [1] 286502 0
Ethics approval number [1] 286502 0

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

Contacts
Principal investigator
Name 33636 0
Address 33636 0
Country 33636 0
Phone 33636 0
Fax 33636 0
Email 33636 0
Contact person for public queries
Name 16883 0
Dr. Carolyn McIntyre
Address 16883 0
270 Joondalup Drive
Joondalup, WA
6027
Country 16883 0
Australia
Phone 16883 0
+61 08 6304 3987
Fax 16883 0
+61 8 6304 2499
Email 16883 0
[email protected]
Contact person for scientific queries
Name 7811 0
Dr. Carolyn McIntyre
Address 7811 0
270 Joondalup Drive
Joondalup, WA
6027
Country 7811 0
Australia
Phone 7811 0
+61 8 6304 3987
Fax 7811 0
+61 8 6304 2499
Email 7811 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.