Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Baseline Strength Test Type: Other
Name: Exercise Type: Other
Overall Status
Recruiting
Summary
The development of clinically relevant and scalable exercise interventions in older cystectomy patients may have an impact upon:

- Patients: Exercise interventions may improve patient outcomes, including quality of life and avoidance of skilled nursing facilities.

- Clinicians: Proving the safety and feasibility of targeted interventions in older surgical patients may facilitate the development of clinically relevant preoperative interventions suitable for wider study and implementation.

- Payers: Improved surgical outcomes among high risk surgical patients will be associated with significant cost savings.

- Researchers: Targeted and well controlled studies focusing on improving surgical outcomes through exercise may provide insight into relationships between patient factors, surgical stressors and outcomes. Ultimately, such work may lead to novel clinical approaches to optimize patients for surgery.

The investigators will study the effects of preoperative exercise training on cystectomy patients, specifically targeting increasing functional capacity and muscular strength. Prior to conducting a more extensive, multi-center, randomized-controlled trial, the feasibility, safety, and initial efficacy of preoperative exercise in cystectomy patients must be determined. To address this issue, the investigators will complete a trial of rehabilitation in cystectomy patients at the University of Michigan.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Both
Criteria: 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.
Location
University of Michigan
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Steven Thelen-Perry - 734-647-3096 - perryste@umich.edu
Start Date
June 2012
Sponsors
University of Michigan
Source
University of Michigan
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page