Clinical trial NCT01840137: Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer
Official title: Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 53
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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.
timeFrame: 3 Years
Secondary outcomes:
measure: Determine the efficacy of prehabilitation on improving functional capacity and strength from baseline levels.
timeFrame: 3 Years
measure: Composite of measures assessing the effects of prehabilitation on peri-operative cystectomy complications, resource utilization, patient reported outcomes, and functional status.
timeFrame: 3 years
measure: Evaluate safety for a prehabilitation program in elderly cystectomy patients.
timeFrame: 3 Years
measure: Rates of attrition for a prehabilitation program in elderly cystectomy patients.
timeFrame: 3 Years
measure: Rates of adherence for a prehabilitation program in elderly cystectomy patients.
timeFrame: 3 Years
measure: Rates of accrual for a prehabilitation program in elderly cystectomy patients.
timeFrame: 3 Years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey S. Montgomery, MD
role: PRINCIPAL_INVESTIGATOR
References: