None listed
Conditions
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.
Interventions
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 througho
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.
Sponsors
Australian Catholic University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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).
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
Outcome results
None listed