Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429813
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-14
Brief Title:
Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT Prostate 006
Sponsor:
Paul Viscuse
Organization:
University of Virginia
Study Overview
Official Title:
A Feasibility Study to Examine the Impact of Remotely Monitored Exercise Interventions on CardiorespiratoryMuscular Fitness and Fatigue in Patients With Metastatic Castrate-sensitive Prostate Cancer mCSPC Undergoing Treatment With Androgen-deprivation Therapy ADT Intensification
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 TherapyARSI 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
Detailed Description:
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 andor 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 sessions the remaining 12 weeks of exercise will occur at home
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 sessions the remaining 12 weeks of exercise will occur at home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None