NCT07302230

Home-Based Physical Activity Program With Digital App Versus Health Education Group for Improving Physical Activity Among Patients With Non-muscle Invasive Bladder Cancer, The EMPOWER Trial

The EMPOWER Trial: Evaluating a Home-Based Physical Activity Program (PAP) With the ExerciseRx™ Digital Platform vs. Health Education Group (HEG) in People With Non-Muscle Invasive Bladder Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial compares how well a home-based personalized physical activity program (PAP) that is delivered by a digital application (app) (the ExerciseRx app) works compared to health education in improving physical activity for patients with bladder cancer that has not reached the muscle wall of the bladder (non-muscle invasive). For people who are not physically active, previous studies have shown that increasing step counts can reduce incidence of death, reduce frailty, and reduce healthcare costs. The ExerciseRx app tracks adherence to home exercise, adapts step count goals based on the patient's progress, and provides encouraging feedback and motivation from the healthcare team. Additional features include activity summaries, progress towards current goal, nudges, helpful facts about the benefits of activity, and ideas for how to incorporate daily movement. A home-based PAP using the ExerciseRx app may work better in increasing physical activity among patients with non-muscle invasive bladder cancer compared to a health education only group.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (Health Education Group, HEG): Patients receive recommendations from their physicians and an educational pamphlet describing physical activity goals in line with National Comprehensive Cancer Network (NCCN) Survivorship for Healthy Living Guidelines. They receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen. GROUP II (PAP INTERVENTION): Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive personalized daily step count goals that gradually increase over the study period. Patients also receive a FitBit® to wear continuously throughout the study, are given access to features of the ExerciseRx app (step count goals, home exercise videos), and receive an educational pamphlet as in Group I. After completion of the study intervention, patients are followed up at 4 weeks.

Conditions

• Localized Non-Muscle Invasive Bladder Urothelial Carcinoma
• Stage 0a Bladder Cancer AJCC v8
• Stage 0is Bladder Cancer AJCC v8
• Stage I Bladder Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Internet-Based Intervention	Given access to the ExerciseRx app
OTHER	Best Practice	Given instruction to continue physical activity as usual
OTHER	Internet-Based Intervention	Given access to the ExerciseRx app locked to the baseline home screen
OTHER	Exercise Intervention	Complete home exercise sessions
OTHER	Health Telemonitoring	Given a FitBit® to wear continuously
OTHER	Educational Intervention	Given NCCN Survivorship for Healthy Living Guidelines pamphlet
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Interview	Ancillary studies
OTHER	Electronic Health Record Review	Ancillary studies

Timeline

• Start date: 2026-03-11
• Primary completion: 2027-02-26
• Completion: 2027-05-31
• First posted: 2025-12-24
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States