Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer
Completed · Not applicable
Conditions studied: Bladder Cancer
In brief
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.
Key facts
- Study ID
- NCT01840137
- Run by
- University of Michigan
- People needed
- 53
- Starts
- 2012-06-01
- Expected to finish
- 2019-04-01
- Last updated by the study team
- 2019-08-08
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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