Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer

NCT ID: NCT01840137

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2019-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prehabilitation

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.

Group Type: EXPERIMENTAL

Baseline Strength Test

Intervention Type: OTHER

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

Exercise

Intervention Type: OTHER

Treadmill and muscle exercises.

Interventions

Baseline Strength Test

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

Intervention Type: OTHER

Exercise

Treadmill and muscle exercises.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Montgomery

Associate Professor, Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey S. Montgomery, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00051581

Identifier Type: -

Identifier Source: org_study_id