Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000284460p
Ethics application status
Not yet submitted
Date submitted
26/02/2016
Date registered
4/03/2016
Date last updated
7/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise to prevent muscle loss during androgen deprivation
Scientific title
Effects of a targeted exercise program on muscle function in men with non-metastatic prostate cancer receiving androgen deprivation therapy (ADT): a randomized, placebo-controlled trial
Secondary ID [1] 288637 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 297810 0
sarcopaenia 297836 0
Condition category
Condition code
Cancer 297985 297985 0 0
Prostate
Musculoskeletal 298008 298008 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be individually randomised to an intervention group (exercise and standard care) or a control group (standard care alone) in a 1:1 ratio according to a computer generated randomisation procedure performed by a third party

Intervention arms: exercise and standard care/ standard care alone
Standard care will involve general lifestyle education for prostate cancer and encouragement to be physically active, in accordance with Australia’s Physical Activity and Sedentary Behaviour Guidelines These include written recommendation to participate in 150-300 mins of moderate activity per week and strength training twice per week (available at http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pubhlth-strateg-phys-act-guidelines).. Those in the intervention arm will, in addition, be provided with an individualised, home-based functional lower limb-strengthening program.

This individualised exercise program will be developed at study entry in the department of physiotherapy at Austin Health. This initial visit will take 90 min. Individualised means that exercise will be tailored to each individual. It is difficult to describe this im detail but in principle, the physiotherapist will assess which muscles are the weakest and provide the participant with a written exercise program accordingly, with clear instructions.

The program will focus on muscles utilised in walking and balance, specifically hip flexors, extensors and abductors, knee extensors and plantarflexors. Exercises will replicate the way muscles are used during walking, with respect to joint position, type of contraction and speed of movement. For example, hip flexors will be strengthened with the hip in an extended position with an emphasis on a fast concentric contraction. Simple equipment such as theraband and cuff weights will be used in conjunction with body weight to provide resistance. Participants will be instructed to perform one to two sets of each exercise, with each set comprising 10 – 15 repetitions at 50 – 70% of 1RM (Repetition Maximum).

This exercise program will be performed twice a week and duration is 30 min. The exercise physiologist will monitor compliance during 5 face to face sessions in the participant’s place of residence (weeks 1, 4, 13, 26, 39) and 5 phone sessions (weeks 2, 9, 19, 32). The sessions at home will take 45 min and the phone sessions 10 min per session. The intervention period will be 12 months.
Intervention code [1] 294048 0
Lifestyle
Intervention code [2] 294067 0
Prevention
Comparator / control treatment
Control treatment is standard care alone:
Standard care will involve general lifestyle education for prostate cancer and encouragement to be physically active, in accordance with Australia’s Physical Activity and Sedentary Behaviour Guidelines These include written recommendation to participate in 150-300 mins of moderate activity per week and strength training twice per week (available at http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pubhlth-strateg-phys-act-guidelines)..
Control group
Active

Outcomes
Primary outcome [1] 297505 0
1) Peak joint torque in knee extension measured by computerised gait analysis.
Timepoint [1] 297505 0
12 months post intervention commencement.
Primary outcome [2] 297523 0
2) soleus contribution to forward acceleration of mass measured by computerised gait analysis.
Timepoint [2] 297523 0
12 months post intervention commencement.
Primary outcome [3] 297560 0
3) Peak joint torque in hip flexion measured by computerised gait analysis.
Timepoint [3] 297560 0
12 months post intervention commencement.
Secondary outcome [1] 321244 0
1) Individual muscle forces (iliopsoas and quadriceps), by computerised gait analysis
Timepoint [1] 321244 0
12 months post intervention commencement.
Secondary outcome [2] 321296 0
2) composite secondary outcome ofStep width, walking speed and stride length by gait analysis
Timepoint [2] 321296 0
12 months post intervention commencement.
Secondary outcome [3] 321297 0
3) composite secondary outcome of Lean body mass and fat mass, by DEXA
Timepoint [3] 321297 0
12 months post intervention commencement.
Secondary outcome [4] 321298 0
4) Physical activity by accelerometers
Timepoint [4] 321298 0
12 months post intervention commencement.
Secondary outcome [5] 321301 0
Quality of Life
Prostate cancer-specific quality of life will be assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) instrument.
Timepoint [5] 321301 0
12 months post intervention commencement.

Eligibility
Key inclusion criteria
ADT naive men with localised non-metastatic prostate cancer (T1-3NxM0), age 50-80 years about to commence treatment with GnRH agonists to suppress androgen production, in whom treatment with ADT is intended for at least 12 months, who live independently in the community, and are ambulant, fully active, and unrestricted in their physical activities.
Minimum age
50 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) Impaired performance status (ECOG < 1), neuromuscular disease, or requiring a walking aid.
2) Evidence of androgen deficiency or baseline serum total T <10nmol/L.
3) Active cardiac, respiratory or joint disease affecting exercise tolerance or muscle function.
4) Corticosteroid or recreational drug use, alcohol dependence or any disease likely to lead to serious illness or death within the study period.
5) Participated in a regular strength training program (2 or more times per week for more than 6 weeks) in the last 12 months.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not 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
5/02/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292997 0
Self funded/Unfunded
Name [1] 292997 0
Currently being applied for
Country [1] 292997 0
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 291770 0
None
Name [1] 291770 0
Address [1] 291770 0
Country [1] 291770 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 294503 0
Austin Health HREC
Ethics committee address [1] 294503 0
Studley Road
Heidelberg, VIC 8081
Ethics committee country [1] 294503 0
Australia
Date submitted for ethics approval [1] 294503 0
02/05/2016
Approval date [1] 294503 0
Ethics approval number [1] 294503 0

Summary
Brief summary
This study aims to investigate the effects of a targeted exercise program on muscle function in men with non-metastatic prostate cancer receiving androgen deprivation therapy (ADT). Who is it for? You may be eligible to join this study if you are a male aged 50-80 years with non-localised non-metastatic prostate cancer, and are about to commence androgen deprivation therapy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive routine recommendations for healthy lifestyle. Participants in the other group will undertake an exercise program which will be home-based and administered by an exercise physiologist The exercise physiologist will design a program tailored to each participant to strengthen lower limb muscles.. After 12 months all participants will undertake physical testing to evaluate any effects of the exercise program. They will also be asked to complete a questionnaire evaluating quality of life. It is hoped that the exercise program will help to prevent muscle loss, which is a major adverse effect of ADT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63950 0
A/Prof Mathis Grossmann
Address 63950 0
The University of Melbourne, Department of Medicine, Austin Health
Head of Andrology, Austin Health
Level 7 Room 3 Lance Townsend Building
145 Studley Road, Heidelberg, VIC 3084, Australia
Country 63950 0
Australia
Phone 63950 0
+61394965000
Fax 63950 0
Email 63950 0
[email protected]
Contact person for public queries
Name 63951 0
A/Prof Mathis Grossmann
Address 63951 0
The University of Melbourne, Department of Medicine, Austin Health
Head of Andrology, Austin Health
Level 7 Room 3 Lance Townsend Building
145 Studley Road, Heidelberg, VIC 3084, Australia
Country 63951 0
Australia
Phone 63951 0
+61394965000
Fax 63951 0
Email 63951 0
[email protected]
Contact person for scientific queries
Name 63952 0
A/Prof Mathis Grossmann
Address 63952 0
The University of Melbourne, Department of Medicine, Austin Health
Head of Andrology, Austin Health
Level 7 Room 3 Lance Townsend Building
145 Studley Road, Heidelberg, VIC 3084, Australia
Country 63952 0
Australia
Phone 63952 0
+61394965000
Fax 63952 0
Email 63952 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

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