Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001267347
Ethics application status
Approved
Date submitted
28/08/2017
Date registered
1/09/2017
Date last updated
1/12/2020
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
PEX Trial: Efficacy of a pre- and post-operative exercise medicine intervention on sexual function and urinary incontinence in men with prostate cancer
Scientific title
Efficacy of a pre- and post-operative exercise medicine intervention on sexual function and urinary incontinence in men with prostate cancer: A randomised controlled trial
Secondary ID [1] 292718 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 304484 0
Condition category
Condition code
Cancer 303819 303819 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The physical exercise intervention program is initiated 1-2 months before surgery and, following a 1-month recovery period, re-commences for 3 months after surgery. Exercise sessions will be conducted in small groups of up to 10 participants under the supervision of an accredited exercise physiologist. The exercise intervention will involve resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling) undertaken 3 times per week at various exercise clinics/gyms throughout Melbourne. Specifically, the aerobic exercise component will include 20 to 30 minutes of moderate to vigorous intensity cardiovascular exercise (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. Participants will be encouraged to undertake additional home-based aerobic exercise with the goal of achieving a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. The resistance exercise component will involve 6-8 exercises that target the major upper and lower body muscle groups. Intensity will be manipulated from 6-12 repetition maximum (RM; i.e. the maximal weight that can be lifted 6 to 12 times which is equivalent to ~60-85% of 1RM) using 1-4 sets per exercise. Exercise prescription will be progressive and modified according to individual response. Exercise sessions will take approximately 60 minutes and will be supervised by an experienced EP. Compliance and attendance (including the reason for any missed sessions) will be tracked throughout the program by the EP. In addition participants will receive best-practice pelvic floor physiotherapy treatment before and after surgery. The pelvic floor program includes the following components: 1) one-on-one session with a specialist continence physiotherapist prior to surgery which incorporating an examination pelvic floor muscles via real-time ultrasound or digital rectal examination, education of the anatomy and function of pelvic floor muscles and instruction on how to correctly contract the pelvic floor muscles; 2) educational booklet; 3) individualized home-based pelvic floor muscle training program consisting of a combination of strength holds, coordination holds, endurance holds, and functional pelvic floor exercises (such as a pelvic floor contraction with sit to stand or coughing); 4) one-on-one session with a specialist continence physiotherapist one month after surgery to review their home based program.
Intervention code [1] 298965 0
Lifestyle
Comparator / control treatment
Participants in the Usual Care group will maintain standard usual care throughout this research trial. Usual care involves standard medical care. Participants will receive the same best-practice pelvic floor physiotherapy treatment before and after surgery as the exercise group.
Control group
Active

Outcomes
Primary outcome [1] 303187 0
Sexual Function – assessed by composite of International Index of Erectile Function, Expanded Prostate Cancer Composite-Sexual Function and EORTC Quality of Life Questionnaire-Prostate Sexual Domain (in order to comprehensively assess all domains of sexual functioning)
Timepoint [1] 303187 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Primary outcome [2] 303188 0
Urinary incontinence – assessed by composite of the 24 hr pad test, Expanded Prostate Cancer Composite-Urinary and International Consultation on Incontinence Questionnaire – Short Form (in order to comprehensively assess all domains of urinary incontinence)
Timepoint [2] 303188 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [1] 338177 0
Quality of life - assessed by the Medical Outcomes Short Form (SF-36)
Timepoint [1] 338177 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [2] 338178 0
Prostate cancer specific quality of life - assessed by the EORTC QLQ-C30 and QLQ-PR25 questionnaires
Timepoint [2] 338178 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [3] 338179 0
Utilisation of sexual aids and continence aids - assessed by a previously developed scale. The use of all aids will be documented and impact of these aids rated.
Timepoint [3] 338179 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [4] 338180 0
Cancer-specific psychological distress - assessed by brief symptom inventory-18 (BSI-18)
Timepoint [4] 338180 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [5] 338181 0
Gender specific symptoms of psychological distress - assessed by the Male Depression Risk Scale (MDRS-22)
Timepoint [5] 338181 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [6] 338182 0
Masculine Self-Esteem - assessed by the Masculinity in Chronic Disease Inventory
Timepoint [6] 338182 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [7] 338183 0
Physical activity levels - assessed by the Godin Leisure-Time Exercise Questionnaire (Godin)
Timepoint [7] 338183 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [8] 338184 0
Aerobic capacity - assessed using the 6-minute walk test
Timepoint [8] 338184 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [9] 338185 0
Functional mobility - assessed using a timed up and go test
Timepoint [9] 338185 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)
Secondary outcome [10] 338186 0
Body Composition (regional and whole body lean mass and fat mass) - derived from whole body dual-energy X-ray absorptiometry (DXA) scans
Timepoint [10] 338186 0
Baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months)

Eligibility
Key inclusion criteria
1) men diagnosed with localised prostate cancer who are scheduled for radical prostatectomy
2) radical prostatectomy to be performed by one of four selected surgeons (Tony Costello, Justin Peters, Phil Dundee or Homi Zaargar).
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) neoadjuvant prostate cancer treatment
2) any medical condition that would increase the risk of injury and/or inhibit exercise participation (as determined by the patient’s physician)
3) inability to participate in at least two weeks of exercise prior to the scheduled radical prostatectomy
4) unable to read and speak English

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. Written informed consent will be required prior to any testing or randomisation. Participants who dropout prior to completing baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by a randomisation table created by a computer sequence. Randomisation is at the level of the individual patient and will be stratified by 1) operating surgeon (Tony Costello vs Justin Peters vs Phil Dundee vs Homi Zaargar); 2) time to surgery (<1 month vs >=1 month); 3) age (<70 vs >=70 ); 4) percent body fat; 5) sexual activity levels (not at all/a little vs. quite a bit/very much) as determined by the response to QLQ-PR25 question 51; and 6) Exercise level (never/rarely vs. sometimes/often) as determined by the response to Godin question 2.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/10/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8850 0
Royal Melbourne Hospital - City campus - Parkville

Funding & Sponsors
Funding source category [1] 297360 0
University
Name [1] 297360 0
Australian Catholic University
Country [1] 297360 0
Australia
Funding source category [2] 297389 0
Charities/Societies/Foundations
Name [2] 297389 0
Australian Prostate Cancer Research
Country [2] 297389 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Australian Catholic University
215 Spring Street
Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 296336 0
Individual
Name [1] 296336 0
A/Prof Prue Cormie
Address [1] 296336 0
Australian Catholic University
215 Spring Street
Melbourne, VIC 3000
Country [1] 296336 0
Australia
Secondary sponsor category [2] 296373 0
Other Collaborative groups
Name [2] 296373 0
Australian Prostate Cancer Research
Address [2] 296373 0
Level 8, 14-20 Blackwood Street,
North Melbourne, VIC 3051
Country [2] 296373 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298460 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 298460 0
Level 2
South West
300 Grattan Street
Parkville
Victoria 3052
Ethics committee country [1] 298460 0
Australia
Date submitted for ethics approval [1] 298460 0
23/04/2018
Approval date [1] 298460 0
25/06/2018
Ethics approval number [1] 298460 0
Ethics committee name [2] 298462 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [2] 298462 0
Australian Catholic University
40 Edward Street
North Sydney
NSW 2060
Ethics committee country [2] 298462 0
Australia
Date submitted for ethics approval [2] 298462 0
29/06/2018
Approval date [2] 298462 0
06/07/2018
Ethics approval number [2] 298462 0

Summary
Brief summary
The aim of this study will be to examine the efficacy of a targeted pre- and post-operative exercise program on treatment related side effects after radical prostatectomy.

Who is it for?
You may be eligible to join this study if you are a male aged 18 years or above and are scheduled for radical prostatectomy by one of the four selected surgeons.

Study details
Participants in this study will be randomly allocated (by chance) to one of two groups: 1) Exercise; or 2) Usual Care. The exercise group will participate in a structured exercise program 1-2 months before surgery and for 3 months after their surgery. The intervention involves individualized exercise prescription supervised by exercise physiologists during 3 group-based sessions weekly in an exercise clinic. The usual care group will receive standard medical care. Both the Exercise and Usual care will receive best-practice pelvic floor physiotherapy treatment before and after surgery.
Assessments will be conducted at the following time points: baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months).

We hypothesize that a structured exercise intervention tailored to men with prostate cancer delivered prior to and continuing after surgery will improve patient's rehabilitation outcomes after surgery, in particular attenuate the severity of sexual dysfunction and urinary incontinence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77154 0
A/Prof Prue Cormie
Address 77154 0
Australian Catholic University
215 Spring Street
Melbourne, VIC 3000
Country 77154 0
Australia
Phone 77154 0
+61 (0)3 9230 8242
Fax 77154 0
Email 77154 0
[email protected]
Contact person for public queries
Name 77155 0
A/Prof Prue Cormie
Address 77155 0
Australian Catholic University
215 Spring Street
Melbourne, VIC 3000
Country 77155 0
Australia
Phone 77155 0
+61 (0)3 9230 8242
Fax 77155 0
Email 77155 0
[email protected]
Contact person for scientific queries
Name 77156 0
A/Prof Prue Cormie
Address 77156 0
Australian Catholic University
215 Spring Street
Melbourne, VIC 3000
Country 77156 0
Australia
Phone 77156 0
+61 (0)3 9230 8242
Fax 77156 0
Email 77156 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.