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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | HIIT Cycling Intervention |
|
| Arm B | Experimental | Walking Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Based Exercise Intervention - Walking | Behavioral | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who complete the post-intervention follow-up assessment | Percentage of participants who complete the post-intervention follow-up assessment | 14 weeks from the start of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment engagement with intervention | Frequency, intensity and duration of exercise as measured by the activity monitors. | From the beginning of the intervention to the Post-intervention visit (about 12 weeks) |
| Acceptability of exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Goff | Contact | 434-806-1357 | WRS9HW@uvahealth.org | |
| Christine Martin | Contact | CMP2P@uvahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Paul Viscuse, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| Home-Based Exercise Intervention - HIIT Cycling | Behavioral | 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 |
|
The Physical Activity Enjoyment Scale (PACES) is an 18 question, 7 point scale that includes questions regarding enjoyment of physical activity in the study.
| 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. | 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 | Each month for 12 months (estimated duration of accrual of participants) |
| Physical fitness (Cardiorespiratory) | As measured by VO2 peak | 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) | Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
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