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Phase 1/Phase 2
60 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information


Inclusion Criteria:



- Patients must have biopsy-proven bladder cancer.

- Patients age ≥60, diagnosed with bladder cancer with planned cystectomy and urinary
diversion, +/- neoadjuvant chemotherapy.

- The patient must be able to communicate and understand/complete forms/instructions,
and be able to provide informed written consent prior to enrollment. Patients may
have the assistance of an interpreter or surrogate when completing forms/surveys as
needed.

- Karnofsky performance status ≥70 with the ability to walk unassisted.

- Sedentary baseline lifestyle, with an average of <180 minutes/week of
moderate-intensity aerobic activity.

- Attending surgeon clearance to undergo a supervised exercise training program.

Exclusion Criteria:

- Contraindication to exercise training, such as skeletal metastases, symptomatic
coronary artery disease, severe anemia, or any condition limiting their ability to
participate in an exercise training program.

- Patients who require surgery sooner than 28 days from enrollment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

Assess whether a pre-operative exercise training program (Prehabilitation) for elderly patients undergoing cystectomy for bladder cancer will lower their post-operative 90-day hospital readmission rate.

Outcome Description:

The study will compare the readmission rate of 70 recruited prehabilitation patients to the historic readmission rates from our institution and the published literature. Readmission will be defined as an admission to any acute care hospital after initial discharge from the immediate post-operative stay within 90 days of surgery. Visits to emergency rooms or urgent, unscheduled outpatient evaluations will be tracked, but will not count as a readmission. We will also track instances in which patients experience multiple re-admissions within 90 days of surgery, but for the purposes of this study, multiple re-admissions for an individual patient will only count as a single readmission event.

Outcome Time Frame:

3 Years

Safety Issue:

No

Principal Investigator

Jeffrey S. Montgomery, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

HUM00051581

NCT ID:

NCT01840137

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms

Name

Location
University of Michigan Ann Arbor, Michigan  48109-0624