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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment (t1) to 3-4 months post enrollment (after nac and before rc) (t2)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
My bladder cancer is invasive but has not spread to distant parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment (t1) to 3-4 months post enrollment (after nac and before rc) (t2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment (t1) to 3-4 months post enrollment (after nac and before rc) (t2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in physical function
Secondary outcome measures
(P)REHAB-associated adverse events
Average daily sedentary time
Average daily step count
+13 moreTrial 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, during receipt of SOC NAC prior to SOC RC and for 90 days following surgery (total ~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 during receipt of SOC NAC prior to SOC RC and for 90 days following surgery (total ~7 months).
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,632 Total Patients Enrolled
Bladder Cancer Advocacy NetworkUNKNOWN
Sarah PsutkaPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still space available for participants in this clinical trial?
"Per the details found on clinicaltrials.gov, this trial is no longer accepting patients as of September 18th 2023. However, there are numerous other trials that still require participants at present and 319 remain open for recruitment."
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