Completed

Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer

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What is being tested

Baseline Strength Test

+ Exercise

Other
Who is being recruted

Urogenital Diseases+8

+ Urinary Bladder Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 60 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorUniversity of Michigan
Last updated: August 8, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01840137
Principal SponsorUniversity of Michigan
Last updated: August 8, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

53 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesUrinary Bladder DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesUrinary Bladder Neoplasms

Criteria

6 inclusion criteria required to participate
Attending surgeon clearance to undergo a supervised exercise training program
Karnofsky performance status >= 70 with the ability to walk unassisted
Patients age >= 60, diagnosed with bladder cancer with planned cystectomy and urinary diversion, +/- neoadjuvant chemotherapy
Patients must have biopsy-proven bladder cancer
Show More Criteria
2 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Michigan

Ann Arbor, United StatesOpen University of Michigan in Google Maps
CompletedOne Study Center