This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)/ARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.
The purpose of this study is to find out how many patients who are being treated for mCSPC complete one of two home-based exercise programs. The researchers want to find out how much exercise participants complete and how satisfied they are with the program. Another purpose of this study is to learn if doing the exercise changes fitness levels and/or muscle strength, and what relationship those changes might have on feeling tired during cancer treatment. Participants will be randomly assigned (like the flip of a coin) to one of two home-based exercise programs: * Arm A: A high intensity interval (HIIT) stationary bike program * Arm B: A walking program Participants in the cycling group (Arm A) will receive a stationary exercise bike for home exercise. All participants in the study (Arms A and B) will receive an activity monitor (watch) and a heart rate-monitoring chest strap that sends information back to the study team. Participants will receive 1-2 exercise training sessions, held in a UVA research lab, to allow them to experience the level of the exercise they will be asked to complete. Each participant will make a personal plan with the study team to gradually workup to the exercise goal assigned to each group. The research team will answer any questions and help set up the activity monitors. After these session(s), the remaining 12 weeks of exercise will occur at home.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
24
30 minutes of walking or light jogging a day at a moderate intensity for 30 minutes a day, 5 days a week for 12 weeks
Four, 4 minute high intensity intervals of exercise, separated by 3 minutes of lower intensity exercise + a 10 minute warm up and 5 minute cool down for 40 minutes a day, 3 days a week for 12 weeks
University of Virginia
Charlottesville, Virginia, United States
RECRUITINGNumber of participants who complete the post-intervention follow-up assessment
Percentage of participants who complete the post-intervention follow-up assessment
Time frame: 14 weeks from the start of the intervention
Treatment engagement with intervention
Frequency, intensity and duration of exercise as measured by the activity monitors.
Time frame: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Acceptability of exercise
The Physical Activity Enjoyment Scale (PACES) is an 18 question, 7 point scale that includes questions regarding enjoyment of physical activity in the study.
Time frame: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Patient-reported outcomes on exercise
Exit interviews include open and closed ended questions about the participant's experience in the study.
Time frame: From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
Rate of recruitment per month
Number of individuals screened and randomized
Time frame: Each month for 12 months (estimated duration of accrual of participants)
Physical fitness (Cardiorespiratory)
As measured by VO2 peak
Time frame: Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)
Muscular strength (quadriceps)
Isometric and isokinetic torque in multiple positions (e.g. 60-120 degrees)
Time frame: Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later
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