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Home-Based Exercise for Bladder Cancer

N/A

Recruiting

Led By Sarah Psutka

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Diagnosis of American Urological Association (AUA) nonmetastatic muscle-invasive bladder cancer (MIBC) (e.g. American Joint Committee on Cancer [AJCC] pT2-4 N0-1 M0)

Must not have

Patients with baseline/preexisting renal dysfunction (e.g. creatinine clearance < 50 ml/min)

Eastern Cooperative Oncology Group (ECOG) > 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how exercise before surgery may help improve physical function and outcomes in people with bladder cancer.

Who is the study for?

This trial is for adults over 18 with non-metastatic muscle-invasive bladder cancer who are English-speaking, scheduled for chemotherapy and surgery, can use a smart device, and consent to participate. Excluded are those with immune deficiencies, severe hearing loss or neuropathy, allergies to platinum drugs, pregnancy, certain heart conditions or psychiatric illnesses that affect compliance.

What is being tested?

The trial tests a home-based exercise program delivered via an app (ExerciseRx) to improve physical function before radical cystectomy in bladder cancer patients. It includes core strength exercises and step count goals using wearables and tracks progress through interviews and questionnaires.

What are the potential side effects?

Since the intervention involves pre-surgery exercises rather than medication, side effects may include typical exercise-related issues such as muscle soreness or strain but should be minimal if performed correctly under guidance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My bladder cancer is invasive but has not spread to distant parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced with a creatinine clearance below 50 ml/min.

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I am mostly bedridden due to my health condition.

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I have a weakened immune system due to a condition or treatment.

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My CD4 count is below 200 due to HIV/AIDS.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I cannot have certain bladder treatments due to health reasons.

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I have significant hearing loss or constant ringing in my ears.

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I have moderate to severe nerve pain or numbness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in physical function

Trial recruitment

Trial retention

Secondary study objectives

(P)REHAB-associated adverse events

Average daily sedentary time

Average daily step count

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A ([P]REHAB intervention)Experimental Treatment6 Interventions

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, 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 II: Arm B (standard of care)Active Control5 Interventions

Patients receive SOC educational materials and wear a FitBit and use the FitBit app prior to SOC surgery and for 90 days following surgery (total \~4-7 months).

0 / 10Eligibility criteria met