Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer



Status:Active, not recruiting
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:60 - Any
Updated:1/23/2019
Start Date:June 2012
End Date:December 2019

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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.


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.
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Jeffrey S. Montgomer, MD
Phone: 734-647-3096
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
from
Ann Arbor, MI
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