Prehabilitation refers to the process of improving a patient's functional capabilities prior to a surgical procedure with the goal of decreasing post-surgical inactivity and physical decline. This clinical trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients before routine radical surgery for bladder or upper tract urothelial cancer. The exercise intervention includes at-home exercise sessions focused on the improvement of core strength and balance as well as personalized step count goals, delivered to patients remotely via a smart-device-based application (ExerciseRx). Encouraging physical activity before surgery may improve physical function and surgical outcomes in patients who are scheduled to undergo surgery for their bladder or upper tract urothelial cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06040762.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Get Moving Research Coordinator
Phone: 206-210-4040
FEASIBILITY OBJECTIVE:
I. To evaluate the feasibility and usability of the study intervention.
PRIMARY OBJECTIVE:
I. To compare the change in physical function associated with the study intervention between time points 1 and 2, between time points 2 and 3, and between time points 1 and 3.
SECONDARY OBJECTIVES:
I. Differences between timepoints 1 and 2, and 2 and 3, will also be assessed to better understand when the impact of the intervention is occurring.
II. To evaluate the impact of the study intervention on frailty, body composition, health-related quality of life, neoadjuvant chemotherapy (NAC)-associated adverse events, and surgical complications.
OUTLINE: Patients are randomized to 1 of 2 arms and are followed from enrollment through chemotherapy (if applicable) and/or surgery, and for 90 days following surgery (total estimated time on study: ~7 months).
ARM A: Starting at least 4 weeks prior to date of surgery, patients use the ExerciseRx application (app) to follow the (P)REHAB exercise program, which consists of four 20-30 minute home exercise sessions per week and personalized step count goal setting and tracking, while receiving standard of care (SOC) chemotherapy, if applicable, prior to SOC surgery, and for 90 days following surgery. Patients also wear a FitBit and use the FitBit app on study.
ARM B: Patients receive SOC educational materials and, starting at least 4 weeks prior to date of surgery, patients wear a FitBit and use the FitBit app while receiving SOC chemotherapy, if applicable, prior to SOC surgery.
After completion of study intervention, patients are followed up at 90 days following SOC surgery.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorSarah P Psutka