Bladder CancerNCT06040762
A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial
A study testing Best Practice, Exercise Intervention and App-Based Intervention in people with Bladder Cancer and Urothelial Carcinoma, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma, Upper Tract Urothelial Carcinoma
- What is being tested?
- Best Practice, Exercise Intervention and App-Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Get Moving Research Coordinator, 206-210-4040, GetMoving@uw.edu
Sarah Psutka
About this study
Official title: 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.
Read the 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 Google Health 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 Google Health 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
- Being tested
- Best Practice, Exercise Intervention, App-Based Intervention, Interview, Wearable Activity Tracker
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive SOC educational materials
Exercise InterventionOther
Receive (P)REHAB exercise program
App-Based InterventionOther
Use ExerciseRx app
App-Based InterventionOther
Use Google Health app
InterviewOther
Ancillary studies
Wearable Activity TrackerOther
Wear FitBit
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A ([P]REHAB intervention) | Experimental | 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 Google Health app and wear a FitBit throughout the study. Receives: Other: Exercise Intervention; Other: App-Based Intervention; Other: Interview; Other: Wearable Activity Tracker; Other: Physical Performance Testing; Other: Questionnaire Administration |
| Arm B (standard of care) | Active comparator | Patients receive SOC educational materials and, starting at least 4 weeks prior to date of surgery, patients wear a FitBit and use the Google Health app while receiving SOC chemotherapy, if applicable, prior to SOC surgery. Receives: Other: Best Practice; Other: App-Based Intervention; Other: Wearable Activity Tracker; Other: Physical Performance Testing; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial recruitment
Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
Secondary outcomes (23)
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.
Measured: 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
Measured: Through study completion, on average 7 months
Frailty
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start19 Dec 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bladder Cancer Advocacy Network
- Responsible party
- Sponsor
- Investigators
- Sarah Psutka, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040762
- Sponsor's protocol ID
- RG1123479
- Other IDs
- NCI-2023-05596, RG1123479, FHIRB0020171
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40441948
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Get Moving Trial": A Phase I/II RCT of Home-Based (P)Rehabilitation With ExerciseRx in Bladder Cancer and Upper Tract Urothelial Cancer
- ClinicalTrials.gov ID
- NCT06040762
- Acronym / sponsor ID
- RG1123479
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Upper Tract Urothelial Carcinoma, Renal Pelvis and Ureter Urothelial Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Bladder Cancer Advocacy Network
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Google Health 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 Google Health 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A ([P]REHAB intervention) | Experimental | Other: Exercise Intervention, Other: App-Based Intervention, Other: Interview, Other: Wearable Activity Tracker, Other: Physical Performance Testing, Other: Questionnaire AdministrationStarting 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 Google Health app and wear a FitBit throughout the study. |
| Arm B (standard of care) | Active comparator | Other: Best Practice, Other: App-Based Intervention, Other: Wearable Activity Tracker, Other: Physical Performance Testing, Other: Questionnaire AdministrationPatients receive SOC educational materials and, starting at least 4 weeks prior to date of surgery, patients wear a FitBit and use the Google Health app while receiving SOC chemotherapy, if applicable, prior to SOC surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive SOC educational materials | Other | Arm B (standard of care) |
| Exercise InterventionReceive (P)REHAB exercise program | Other | Arm A ([P]REHAB intervention) |
| App-Based InterventionUse ExerciseRx app | Other | Arm A ([P]REHAB intervention) |
| App-Based InterventionUse Google Health app | Other | Arm A ([P]REHAB intervention), Arm B (standard of care) |
| InterviewAncillary studies | Other | Arm A ([P]REHAB intervention) |
| Wearable Activity TrackerWear FitBit | Other | Arm A ([P]REHAB intervention), Arm B (standard of care) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingAncillary studies | Other | Arm A ([P]REHAB intervention), Arm B (standard of care) |
| Questionnaire AdministrationAncillary studies | Other | Arm A ([P]REHAB intervention), Arm B (standard of care) |
Primary outcome
Trial recruitment
Time frame: At enrollment
Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.
Trial retention
Time frame: Through study completion, on average 4-7 months
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).
Change in physical function
Time frame: From enrollment (T1) to 1-4 months post enrollment (before surgery) (T2)
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.
Change in physical function
Time frame: From 1-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
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.
Change in physical function
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
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.
23 secondary outcomes
Protocol adherence
Time frame: Through study completion, on average 7 months
Patient experience with use of ExerciseRx app, including app engagement ([P]REHAB arm only) (feasibility)
Time frame: Through study completion, on average 7 months
Frailty
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Frailty
Time frame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Frailty
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3
Body composition - fat free mass
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Body composition - fat free mass
Time frame: 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
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
Body composition - fat mass
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Body composition - fat mass
Time frame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Body composition - fat mass
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
Patient-reported health-related quality of life
Time frame: 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
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Patient-reported health-related quality of life - bladder cancer specific
Time frame: 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
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
NAC-associated adverse events
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
(P)REHAB-associated adverse events
Time frame: 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
Time frame: Within 90 days of surgery
Surgical outcomes - length of stay
Time frame: Through study completion, on average 7 months
Surgical outcomes - post discharge disposition
Time frame: Through study completion, on average 7 months
Average daily step count
Time frame: Through study completion, on average 7 months
Provider perceived usability
Time frame: Up to 1 year
Provider perceived utility
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 40441948Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Psutka principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Exercise Intervention and App-Based Intervention in people with Bladder Cancer and Urothelial Carcinoma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Get Moving Research Coordinator (206-210-4040, GetMoving@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial recruitment (time frame: At enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.