None listed
Conditions
Brief summary
This study aims to compare the effectiveness of a telehealth-delivered exercise program against a supervised clinic-based program at improving physical and mental health outcomes for prostate cancer patients. Who is it for? You may be eligible for this trial if you are an overweight/obese male aged 18 years or over, undergoing treatment or previously treated for prostate cancer involving androgen deprivation therapy. Study details Participants will be randomly assigned to a telehealth-delivered program or the supervised clinic-based program involving resistance and aerobic exercise for 6 months and then will be followed up for an additional 6 months. Additional consultations with a dietitian to address nutritional and dietary changes will also be involved. Information from this study will help develop a low cost and feasible program to improve the health outcomes of prostate cancer patients.
Interventions
The interventions will consist of a similar resistance and aerobic exercise program performed over 3 sessions per week for 6 months delivered face-to-face (CENUT) in an exercise clinic or via telehealth (TENUT) by Accredited Exercise Physiologists (AEP). Both TENUT and CENUT groups will undertake resistance training comprising 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 for 6 exercises targeting the major upper and lower body muscle groups performed using different equipment such as exercise machines, dumbbells, Gymsticks™ and elastic bands. Participants will exercise in a group setting of 6-8 people. The aerobic exercise component will involve 15 to 20 minutes of moderate to vigorous intensity cardiovascular exercise using a variety of modes such as walking, jogging or cycling and will be self-directed and undertaken daily. The total duration of the exercise session will be 60 minutes. In addition, participants will also be instructed to perform the general recommendations of 30 min of moderate/vigorous physical activity in the remaining 4 days of the week (a total of 120 minutes per week of moderate physical activity) to achieve at least 300 min of moderate to vigorous physical activity per week. These exercises are up to the participant's choice. For the telehealth intervention we will implement the latest digital platforms and related technological advancements in wearable sensors, online monitoring, cloud-based platforms, and video chat. Participants will receive their exercise program via their smart device or computer, communicate with the AEP and fellow participants by video chat, and be monitored in real-time through the Internet. For the nutrition intervention, all participants will receive a total of 5 face-to-face or online consultations between 30-60 mins over the first 6 months of intervention (baseline, 2, 12, 18, 24 weeks) with an Accredited Practising Dietitian aiming to: 1) achieve an energy deficit of 2100-4200 kJ/day (500-1000 kcal/day); 2) reducing discretionary items including alcoholic drinks and foods containing refined sugars; and 3) maintain protein intake, as well as the consumption of a 40 g whey protein supplement 3 times per week immediately after the resistance exercise sessions. Safety and monitoring will be assessed by recording the incidence and severity of any adverse events. The TENUT group will have their consultations online while the CENUT group will have face-to-face sessions. At the end of the first 6-month period, participants from CENUT will receive a booklet created for the study based on previous exercise oncology guidelines (Hayes et al. 2019, Schmitz et al. 2010) with detailed information about a home exercise prescription, while the telehealth program will be maintained without supervision for participants from TENUT. Instructions on performing the home-based exercises and diet will be provided by the AEP and APD.
Sponsors
Study design
Eligibility
Inclusion criteria
One-hundred and four overweight/obese men (52 participants per arm) undergoing treatment or previously treated for prostate cancer involving androgen deprivation therapy (ADT) will be identified and recruited through attending physicians (general practitioner / radiation oncologist / urologist), specialist nurses, advertisements in local newspapers and presentations at cancer support groups and related events in Western Australia. Inclusion criteria are: 1) body fat percentage great than or equal to 25%, and 2) ability to walk 400-m.
Exclusion criteria
Exclusion criteria are: 1) acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit exercise performance or put participants at risk from exercising, and 2) inability to read and understand English.