NCT06040762

A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial

The "Get Moving Trial": A Phase I/II RCT of Home-Based (P)Rehabilitation With ExerciseRx in Bladder Cancer and Upper Tract Urothelial Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 with urothelial carcinoma undergoing definitive or consolidative surgery of the bladder (radical cystectomy) or upper tract (nephroureterectomy, ureterectomy) with or without preceding neoadjuvant/systemic therapy. 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 urothelial cancer.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 arms and are followed from enrollment through surgery, and for 90 days following surgery (total estimated time on study: \~4-7 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 approximately 4-6 weeks prior to surgery 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.

Conditions

• Bladder Cancer
• Urothelial Carcinoma
• Upper Tract Urothelial Carcinoma
• Renal Pelvis and Ureter Urothelial Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive SOC educational materials
OTHER	Exercise Intervention	Receive (P)REHAB exercise program
OTHER	App-Based Intervention	Use ExerciseRx app
OTHER	App-Based Intervention	Use FitBit app
OTHER	Interview	Ancillary studies
OTHER	Wearable Activity Tracker	Wear FitBit
OTHER	Physical Performance Testing	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-12-19
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2023-09-18
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States