None listed
Conditions
Brief summary
This study is assessing a combined physical and cognitive intervention to improve the quality of life of men affected by prostate cancer receiving androgen deprivation therapy (ADT). Who is it for? You may be eligible for this study if you are are an adult male who has been diagnosed with prostate cancer currently receiving primary ADT for metastatic and nonmetastatic hormone-sensitive prostate cancer. Additionally, you commenced ADT at least six months prior to enrolment and are expected to receive for another 6 months. Study details Participants will be randomly allocated to one of four arms. Arm 1 will involve concurrent physical training (performed on a stationary bike) and cognitive training, Arm 2 will involve physical training only and Arm 3 will involve cognitive training only. These 3 treatment arms will be delivered as 2 x 60-minute sessions per week over 8 weeks. Arm 4 will be a waitlist control group, where participants will be able to select one of the treatment arms to participate in upon conclusion of the study period. All participants will be asked to complete questionnaires assessing their physical and cognitive performance at the start and end of the trial. It is hoped that results from this study will help develop better treatment guidelines for brain fog and fatigue for men undergoing treatment for prostate cancer.
Interventions
The three training interventions will consist of 2 x 60-minute sessions per week for eight weeks, conducted on non-consecutive days. All training sessions will be supervised. Arm 1: Concurrent training For the concurrent physical and cognitive training intervention, participants will cycle on a recumbent cycle ergometer (CXP Target Training Cycle, Matrix Fitness, Australia) for 45 minutes (plus 15-min warm-up/cool-down) at a fixed intensity, relative to their cardiorespiratory fitness (peak oxygen consumption; VO2peak). During the initial week, participants will cycle at a power output corresponding to 65% VO2peak. For all subsequent weeks, the power output will be adjusted to achieve the same heart rate ±5 bpm . This approach will achieve a progressive adaptive overload (increase in the training stimulus as determined by power output) over the training period. While cycling, participants will complete a series of adaptive multi-domain cognitive tasks (including executive functions and working memory) using BrainHQ (Posit Science USA). The touchscreen and/or mouse utilised for responses (task-dependent) will be attached to the stationary bike utilising a customised desk attached immediately above the handlebar. The cognitive training tools from BrainHQ that have been selected: * Double Decision - Visual processing speed, selective attention * Target Tracker - Spatial attention * Mind Bender - Task switching, cognitive flexibility * Hawk Eye - Visual speed and attention * Juggle Factor - Visuospatial memory, tracking * Minds Eye - Visual memory, attention * Scene Crasher - Visual working memory * Eye for Detail - Visual processing speed, visual working memory Arm 2: Physical-only training For the physical-only training intervention, participants will undergo the same physical training as the concurrent intervention, except for completing the cognitive task. Participants will cycle on a recumbent cycle ergometer (CXP Target Training Cycle, Matrix Fitness, Australia) for 45 minutes (plus 15-min warm-up/cool-down) at a fixed intensity, relative to their cardiorespiratory fitness (peak oxygen consumption; VO2peak). During the initial week, participants will cycle at a power output corresponding to 65% VO2peak. For all subsequent weeks, the power output will be adjusted to achieve the same heart rate ±5 bpm . This approach will achieve a progressive adaptive overload (increase in the training stimulus as determined by power output) over the training period. Arm 3: Cognitive-only training For the cognitive-only group, participants will complete the same series of adaptive multi-domain cognitive tasks (including executive functions and working memory) using BrainHQ (Posit Science USA) as the concurrent training group. Participants will be seated at a desk to use the touchscreen and/or mouse utilised for responses (task-dependent). The cognitive training tools from BrainHQ that have been selected: * Double Decision - Visual processing speed, selective attention * Target Tracker - Spatial attention * Mind Bender - Task switching, cognitive flexibility * Hawk Eye - Visual speed and attention * Juggle Factor - Visuospatial memory, tracking * Minds Eye - Visual memory, attention * Scene Crasher - Visual working memory * Eye for Detail - Visual processing speed, visual working memory Those completing the cognitive tasks (cognitive only and concurrent group) will be engaging in tasks that involve the participant: -Responding to stimuli on the screen as quickly as possible -Tracking moving objects to assess divided attention -Challenging mental flexibility by processing changes in rules -Training their field of view visual precision which translates to how much information they can quickly capture -Keeping track of a sequence of moving objects and exercising intelligence by manipulating that sequence -Remembering what they see while ignoring distraction on the screen -Exercising visual memory by quickly taking in and remembering the details of a scene -Transitioning information from working memory (ability to hold what you see in mind) long enough to move it to long-term memory for better recall later. An Accredited Exercise Physiologist (AEP) will fully supervise physical activity assessments given the inherent potential for adverse events in the target population. Specifically, an AEP will monitor all assessments (including ECG surveillance during the aerobic fitness test), acting as an additional screening into the trial. An AEP/exercise scientist will supervise and oversee fidelity measures during the training interventions. Both roles are appropriately trained to monitor and handle adverse events (including first aid trained) with proximity to defibrillators (opposite our lab) and medical support (on-campus) if required. All participants will be recruited to this study under an ethical framework. In terms of adherence, upon arrival for any type of training session, participants will physically sign and date on and attendance tracking sheet that allows manual tracking of the sessions. This will also be captured digitally through and attendance spreadsheet.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants eligible to participate must meet the following inclusion criteria: male >18 years old, diagnosed with prostate cancer currently receiving primary ADT for both metastatic and non-metastatic hormone-sensitive prostate cancer. Further inclusion criteria includes having had at least one dose of ADT in the last six months prior to enrolment; self-assessed reading and writing English proficiency, able to provide written informed consent and who have expected life expectancy of more than 12 months. -self-assessed reading and writing English proficiency, able to provide written informed consent and who have expected life expectancy of more than 12 months.
Exclusion criteria
Based on known interactions with the primary outcome measures, participants will be excluded if they have received chemotherapy or radiation within the last 3 months; they are on steroids equivalent to more than 10 mg of prednisolone a day; opioid-based analgesics within the last 28 days; previous neurological injury; major depression; or are unable to provide written informed consent.