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

Last updated: March 18, 2025
Sponsor: University of Washington
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Carcinoma

Carcinoma

Treatment

Wearable Activity Tracker

Interview

Best Practice

Clinical Study ID

NCT06040762
RG1123479
FHIRB0020171
RG1123479
NCI-2023-05596
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older

  • English-speaking

  • Planned treatment with radical cystectomy or radical nephroureterectomy/ureterectomywith or without preceding systemic therapy as indicated by the patient's surgeonwith enough time to complete a minimum of 4 weeks of exercises before surgery ifenrolled in the (P)REHAB arm

  • Willing and able to participate in trial activities

Exclusion

Exclusion Criteria:

  • Cognitive/mental impairment that will preclude ability to participate in routineexercise activities. Significant cognitive or memory impairment or baseline dementiathat would preclude a patient's ability to follow instructions or reproduceexercises

  • Immobility, inability/unwillingness to perform personalized exercise program.Inability to perform exercises safely from seated or standing position at home orrecent falls or high fall risk. Neurologic or orthopedic condition(s) that restrictsparticipation in unsupervised home exercises, such as prior stroke with neurologicimpairment, weight-bearing precautions, or unwillingness to participate in exercises

  • Participants who have nonmuscle-invasive urothelial cancer of the bladder/uppertract anticipating undergoing organ-preserving treatments, or radiographic evidenceof metastatic disease involving other organs including brain metastases.

  • Patients with predominant histology other than urothelial carcinoma of the bladderor upper tracts (e.g. metastasis from another cancer) who would not otherwise beconsidered candidates for standard definitive or consolidative surgeries (radicalcystectomy, ureterectomy, radical nephroureterectomy) with/without treatment withpreoperative/neoadjuvant systemic therapy.

  • Uncontrolled or concurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith 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 devicewith the minimum criteria for using ExerciseRx

  • Not receiving surgery at UWMC

  • Participation in a clinical trial that does not permit enrollment in the Get Movingtrial

Study Design

Total Participants: 128
Treatment Group(s): 7
Primary Treatment: Wearable Activity Tracker
Phase:
Study Start date:
December 19, 2023
Estimated Completion Date:
October 30, 2026

Study 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: 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, prior to standard of care (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 wear a FitBit and use the FitBit app prior to SOC surgery.

After completion of study intervention, patients are followed up at 90 days following SOC surgery.

Connect with a study center

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington 98109
    United States

    Active - Recruiting

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