An exploratory study to determine if exercise can impact the gut microbiota composition of men receiving androgen deprivation therapy for prostate cancer.

ABSTRACT: Interventions: Men with prostate cancer receiving androgen deprivation therapy will attend three clinic-based supervised exercise sessions each week, for 12 weeks (3 months), consisting of moderate-to-high intensity resistance and aerobic exercise (interval and continuous). Each session will take approximately 60 minutes, including warm-up and cool-down, and will be supervised by accredited exercise physiologists (AEP; Exercise and Sport Science Australia, Brisbane, Australia), face-to-face (in groups of up to 8 people per session). The exercise program is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance and retention, thus will be tailored, progressive, periodised and autoregulated in collaboration with the patient (i.e. adjusted based on the patient’s presentation at each session). Resistance exercise will be prescribed using repetition maximums (RM), where patients will be required to perform 6-8 different resistance exercises using major muscle groups, at 6-12 RM (the maximal weight that can be lifted 6 to 12 times each set, equivalent to ~60-85% of 1RM) for 3-4 sets per exercise to achieve moderate-to-high intensity and volume. Aerobic exercise will include 20 to 30 minutes of moderate-to-vigorous intensity activity (equating to ~60-85% of estimated maximum heart rate; or a rating of perceived exertion (RPE) between 6-9 using the BORG-10 scale) involving a variety of modes including walking, jogging, cycling or rowing, using treadmills and/or stationary ergometers respectively. Aerobic intensity will be monitored using heart rate monitors (Polar M400, H10 Sensor, Polar Electro, NSW, Australia) and an RPE chart for assessment. Patients will also be encouraged to perform additional aerobic exercise Primary outcome(s): Microbiome Behaviour/DNA/Composition Gut Health and Function will be assessed through the provision of a 24-hour collection of stool sample(s); subsequently examined/analysed for microbiome behaviour/DNA/composition. The 24-hour collection of fecal samples will also be collected for comprehensive metabolomics analysis.[Week 0 (baseline) and Week 13 (post-intervention).];Fecal Calprotectin An analysis of fecal calprotectin analysis will be provided analysis also provided as an indicator of Gut Health and Function.[Week 0 (baseline) and Week 13 (post-intervention)] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Oral And Gastrointestinal-other Diseases Of The Mouth, Teeth, Oesophagus, Digestive System Including Liver And Colon,Bowel Function,Physical Medicine / Rehabilitation-other Physical Medicine / Rehabilitation,Prostate Cancer,Cancer-prostate

PROVIDER: 2466687 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR