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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Urothelial Carcinoma; Renal Pelvis and Ureter Urothelial Carcinoma; Upper Tract Urothelial Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Interview; Other: Physical Performance Testing; Other: Exercise Intervention; Other: App-Based Intervention; Other: App-Based Intervention; Other: Wearable Activity Tracker; Other: Best Practice

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Get Moving Research Coordinator; Phone Number: 206-210-4040; Email: GetMoving@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Principal Investigator: Sarah Psutka
      • Contact: Get Moving Research Coordinator; Phone Number: 206-210-4040; Email: GetMoving@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Physical Performance Testing; Ancillary studies; Other Names: Physical Fitness Testing; Physical Function Testing; Other: Exercise Intervention; Receive (P)REHAB exercise program; Other: App-Based Intervention; Use ExerciseRx app; Other: App-Based Intervention; Use FitBit app; Other: Wearable Activity Tracker; Wear FitBit
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Physical Performance Testing; Ancillary studies; Other Names: Physical Fitness Testing; Physical Function Testing; Other: App-Based Intervention; Use ExerciseRx app; Other: App-Based Intervention; Use FitBit app; Other: Wearable Activity Tracker; Wear FitBit; Other: Best Practice; Receive SOC educational materials; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial recruitment	Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.	At enrollment
Trial retention	Trial retention (proportion retained versus all enrolled, reason for not completing) will be described via qualitative report. Successful retention is defined as continued participation within the trial until 4-7 months post enrollment (90 days post surgery) (T3).	Through study completion, on average 4-7 months
Change in physical function	Physical function will be measured by the Short Performance Physical Battery (SPPB). Change in physical function will be measured and compared between the (P)REHAB and standard of care arms. SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with possible sarcopenia but no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. Persons with a score of 2 or lower who have sarcopenia, potential cachexia, and mobility disability are determined to be disabled.	From enrollment (T1) to 1-4 months post enrollment (before surgery) (T2)
Change in physical function	Physical function will be measured by the Short Performance Physical Battery (SPPB). Change in physical function will be measured and compared between the (P)REHAB and standard of care arms. SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with possible sarcopenia but no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. Persons with a score of 2 or lower who have sarcopenia, potential cachexia, and mobility disability are determined to be disabled.	From 1-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Change in physical function	Physical function will be measured by the Short Performance Physical Battery (SPPB). Change in physical function will be measured and compared between the (P)REHAB and standard of care arms. SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with possible sarcopenia but no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. Persons with a score of 2 or lower who have sarcopenia, potential cachexia, and mobility disability are determined to be disabled.	From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protocol adherence	Protocol adherence (proportion adhered versus all enrolled, specifics for how protocol was not followed and why) will be described via qualitative report. Protocol adherence for the (P)REHAB arm is defined as completion of >=70% of all exercise activities (goal 4x weekly, 20-30min/session) as measured using the ExerciseRx app.	Through study completion, on average 7 months
Patient experience with use of ExerciseRx app, including app engagement ([P]REHAB arm only) (feasibility)	Qualitative experience will be assessed by Zoom interviews (usability interview) with a subset of volunteer participants from the (P)REHAB arm and app engagement will be assessed by an affinity analysis of the MAUQ	Through study completion, on average 7 months
Surgical outcomes - post discharge disposition	Surgical outcomes include discharge disposition (e.g. discharge to home vs. short term nursing facility versus rehabilitation unit). For patients not discharged to home, will evaluate length of time in a skilled nursing facility or rehabilitation unit as necessary. Surgical outcomes will be reported via qualitative report	Through study completion, on average 7 months
Average daily step count	Number of steps per day as measured by the FitBit wearable will be reported.	Through study completion, on average 7 months
Average daily sedentary time	Average daily sedentary time as measured by the FitBit wearable will be reported.	Through study completion, on average 7 months
Frailty	Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.	From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Frailty	Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.	From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Frailty	Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.	From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3
Body composition - fat free mass	Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating the skeletal muscle index and fat mass index of deidentified computed tomography scans.	From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Body composition - fat free mass	Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating the skeletal muscle index and fat mass index of deidentified computed tomography scans.	From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Body composition - fat free mass	Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating the skeletal muscle index and fat mass index of deidentified computed tomography scans.	From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
Body composition - fat mass	Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating fat mass index of deidentified computed tomography scans.	From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Body composition - fat mass	Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating fat mass index of deidentified computed tomography scans.	From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Body composition - fat mass	Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating fat mass index of deidentified computed tomography scans.	From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
Patient-reported health-related quality of life	Patient reported health-related quality of life will be assessed by a change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)-C30. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.	At enrollment, 3-4 months from enrollment (before surgery), 4-7 months from enrollment (90 days post surgery)
Patient-reported health-related quality of life - bladder cancer specific	Bladder cancer-specific patient-reported health-related quality of life will be assessed by a change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-Bladder Cancer Muscle-Invasive 30). All subscale and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.	From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Patient-reported health-related quality of life - bladder cancer specific	Bladder cancer-specific patient-reported health-related quality of life will be assessed by a change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-Bladder Cancer Muscle-Invasive 30). All subscale and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.	From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Patient-reported health-related quality of life - bladder cancer specific	Bladder cancer-specific patient-reported health-related quality of life will be assessed by a change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-Bladder Cancer Muscle-Invasive 30). All subscale and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.	From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
NAC-associated adverse events	Will be recorded as both physician-reported adverse events utilizing Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 5.0 and using the patient-reported CTCAE and will be described via qualitative report	From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
(P)REHAB-associated adverse events	Will be assessed by comparing physician-reported CTCAE v. 5.0 adverse events (e.g. falls, pain score as measured using a visual analog scale 0-10, and fatigue), compared between the (P)REHAB and standard of care arms.	At enrollment (T1), 3-4 months from enrollment (before surgery) (T2), 4-7 months from enrollment (90 days post surgery) (T3)
Number of participants with post-surgical complications within 90 days graded using the Clavien grading scale	Graded using the Clavien grading scale and reported qualitatively. The Clavien-Dindo Classification is a grading system used throughout surgery for classifying adverse events (complications) that occur as a result of surgical procedures. The system consists of five (I, II, III, IV and V) or seven (I, II, IIIa, IIIb, IVa, IVb and V) grades of severity, with Grade I being low and Grade V being death.	Within 90 days of surgery
Surgical outcomes - length of stay	Surgical outcomes include length of stay following surgery. Surgical outcomes will be reported via qualitative report.	Through study completion, on average 7 months
Provider perceived usability	Assessed using the System Usability Scale (SUS) score 0-100 with 100 being high usability, User Burden Scale (UBS) score 20-100 with 100 being high burden, and/or Intervention Usability Scale (IUS) score 0-100 with 100 being high usability.	Up to 1 year
Provider perceived utility	Assessed using the System Usability Scale (SUS) score 0-100 with 100 being high usability, User Burden Scale (UBS) score 20-100 with 100 being high burden, and/or Intervention Usability Scale (IUS) score 0-100 with 100 being high usability.	Up to 1 year

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Bladder Cancer Advocacy Network
• Investigators: Principal Investigator: Sarah Psutka, Fred Hutch/University of Washington Cancer Consortium

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Guidelines as Topic; Quality Assurance, Health Care; Heart Function Tests; Respiratory Function Tests; Ergometry; Interviews as Topic; Standard of Care; Practice Guidelines as Topic; Exercise Test
• Other Study ID Numbers: RG1123479 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2023-05596 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); FHIRB0020171 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No