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BRIEF TITLE: Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer


  • Org Study ID: HUM00051581
  • Secondary ID:
  • NCT ID: NCT01840137
  • NCT Alias:
  • Sponsor: University of Michigan - Other
  • Source: University of Michigan

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: June 2012 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - 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.

Primary Outcome 1 - Time Frame: 3 Years

Condition:

  • Bladder Cancer

Eligibility

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.
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Gender: All

Minimum Age: 60 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Official Information

Name: Jeffrey S. Montgomery, MD

Role: Principal Investigator

Affiliation: University of Michigan

Overall Contact

Name: Steven Thelen-Perry

Phone: 734-647-3096

Email: perryste@med.umich.edu

Location

Facility Status Contact
University of Michigan
Ann Arbor, Michigan 48109
United States
Recruiting Steven Thelen-Perry
734-647-3096
perryste@umich.edu