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

NCT ID: NCT06040762

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-19
• Study Completion Date: 2026-10-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arm A ([P]REHAB intervention)

Starting at least 4 weeks prior to date of surgery, patients use the ExerciseRx 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 SOC chemotherapy, if applicable, prior to SOC surgery and for 90 days following surgery (total \~4-7 months). Patients also download the FitBit app and wear a FitBit throughout the study.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

Receive (P)REHAB exercise program

App-Based Intervention

Intervention Type: OTHER

Use ExerciseRx app

App-Based Intervention

Intervention Type: OTHER

Use FitBit app

Interview

Intervention Type: OTHER

Ancillary studies

Wearable Activity Tracker

Intervention Type: OTHER

Wear FitBit

Physical Performance Testing

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm B (standard of care)

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.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive SOC educational materials

App-Based Intervention

Intervention Type: OTHER

Use FitBit app

Wearable Activity Tracker

Intervention Type: OTHER

Wear FitBit

Physical Performance Testing

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Receive SOC educational materials

Intervention Type: OTHER

Exercise Intervention

Receive (P)REHAB exercise program

Intervention Type: OTHER

App-Based Intervention

Use ExerciseRx app

Intervention Type: OTHER

App-Based Intervention

Use FitBit app

Intervention Type: OTHER

Interview

Ancillary studies

Intervention Type: OTHER

Wearable Activity Tracker

Wear FitBit

Intervention Type: OTHER

Physical Performance Testing

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy; Physical Fitness Testing; Physical Function Testing

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• English-speaking
• Planned treatment with radical cystectomy or radical nephroureterectomy/ureterectomy with or without preceding systemic therapy as indicated by the patient's surgeon with enough time to complete a minimum of 4 weeks of exercises before surgery if enrolled in the (P)REHAB arm
• Willing and able to participate in trial activities

Exclusion Criteria

• Cognitive/mental impairment that will preclude ability to participate in routine exercise activities. Significant cognitive or memory impairment or baseline dementia that would preclude a patient's ability to follow instructions or reproduce exercises
• Immobility, inability/unwillingness to perform personalized exercise program. Inability to perform exercises safely from seated or standing position at home or recent falls or high fall risk. Neurologic or orthopedic condition(s) that restricts participation in unsupervised home exercises, such as prior stroke with neurologic impairment, weight-bearing precautions, or unwillingness to participate in exercises
• Participants who have nonmuscle-invasive urothelial cancer of the bladder/upper tract anticipating undergoing organ-preserving treatments, or radiographic evidence of metastatic disease involving other organs including brain metastases.
• Patients with predominant histology other than urothelial carcinoma of the bladder or upper tracts (e.g. metastasis from another cancer) who would not otherwise be considered candidates for standard definitive or consolidative surgeries (radical cystectomy, ureterectomy, radical nephroureterectomy) with/without treatment with preoperative/neoadjuvant systemic therapy.
• Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study
• Inability to understand or read English
• Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using ExerciseRx
• Not receiving surgery at UWMC
• Participation in a clinical trial that does not permit enrollment in the Get Moving trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bladder Cancer Advocacy Network

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Psutka

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Get Moving Research Coordinator

Role: CONTACT

GetMoving@uw.edu

206-210-4040

Facility Contacts

Get Moving Research Coordinator

Role: primary

GetMoving@uw.edu

206-210-4040

References

Zhu A, Sher J, Li R, Ioseliani O, Cantor L, Brewer EG, Landis K, Bridges D, Munson SA, Hunter H, Lin C, Psutka SP. What motivates bladder cancer patients to be active? A qualitative study assessing attitudes towards physical activity and digital health technologies. Urol Oncol. 2025 Sep;43(9):522.e1-522.e8. doi: 10.1016/j.urolonc.2025.05.002. Epub 2025 May 28.

Reference Type: DERIVED

PMID: 40441948 (View on PubMed)

Other Identifiers

NCI-2023-05596

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG1123479

Identifier Type: OTHER

Identifier Source: secondary_id

FHIRB0020171

Identifier Type: OTHER

Identifier Source: secondary_id

RG1123479

Identifier Type: -

Identifier Source: org_study_id