Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer

NCT01840137 | Completed DMC

• 1 other identifier: HUM00051581
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  The study will compare the readmission rate of 70 recruited prehabilitation patients to the historic readmission rates from our institution and the published literature. Readmission will be defined as an admission to any acute care hospital after initial discharge from the immediate post-operative stay within 90 days of surgery. Visits to emergency rooms or urgent, unscheduled outpatient evaluations will be tracked, but will not count as a readmission. We will also track instances in which patients experience multiple re-admissions within 90 days of surgery, but for the purposes of this study, multiple re-admissions for an individual patient will only count as a single readmission event.

  3 Years

Secondary Outcomes (6)

• Determine the efficacy of prehabilitation on improving functional capacity and strength from baseline levels.

  3 Years

• Composite of measures assessing the effects of prehabilitation on peri-operative cystectomy complications, resource utilization, patient reported outcomes, and functional status.

  3 years

• Evaluate safety for a prehabilitation program in elderly cystectomy patients.

  3 Years

• Rates of attrition for a prehabilitation program in elderly cystectomy patients.

  3 Years

• Rates of adherence for a prehabilitation program in elderly cystectomy patients.

  3 Years

Study Arms (1)

Prehabilitation

EXPERIMENTAL

The progressive, pre-operative exercise training program includes 3 supervised exercise sessions per week for 4 weeks. The first week of training will include an acclimation period accomplished via a ramping protocol. Subjects will warm-up on a treadmill for 5-minutes. Subjects will then complete 1 set of 15 repetitions exercising 8 major muscle groups during week one; during week #2 they will complete 2 sets with a goal of at least 12 repetitions; if subjects reach 15 repetitions on the second set, the resistance will be increased by 10% at the next training session to ensure progression. After completion of the resistance training portion of each session, subjects will walk on a treadmill for 30 minutes at a low/moderate intensity followed by a 5 minutes cool-down period.

Other: Baseline Strength Test; Other: Exercise

Interventions

Baseline Strength Test OTHER

A symptom limited submaximal cardiopulmonary exercise test to estimate the subject's exercise capacity.

Prehabilitation

Exercise OTHER

Treadmill and muscle exercises.

Prehabilitation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jeffrey S. Montgomery, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Urology

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 25, 2013
• Study Start: June 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2019
• Last Updated: August 8, 2019

Record last verified: 2019-08

Locations

US (1)