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The development of clinically relevant and scalable exercise interventions in older cystectomy patients may have an impact upon:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline Strength Test | Other | A symptom limited submaximal cardiopulmonary exercise test to estimate the subject's exercise capacity. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the efficacy of prehabilitation on improving functional capacity and strength from baseline levels. | A submaximal exercise test and 6 minute walk test will be used to assess the maximal rate of oxygen utilization and functional capacity at baseline and at the conclusion of the intervention period. Muscular strength will be evaluated using volume loading. | 3 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey S. Montgomery, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise | Other | Treadmill and muscle exercises. |
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| Composite of measures assessing the effects of prehabilitation on peri-operative cystectomy complications, resource utilization, patient reported outcomes, and functional status. | Early (within 30 days of surgery) and late (between 31 and 90 days of surgery) complications, length of hospital stay, resource utilization (emergency room visits, need for sub-acute rehabilitation or nursing home stays, and the costs associated with this additional care) and post-operative outcomes, such as functional capacity and quality of life, will be evaluated and compared to historic data available in the published literature. | 3 years |
| Evaluate safety for a prehabilitation program in elderly cystectomy patients. | The endpoint for safety is the prevalence of adverse events during study-related assessments and exercise training sessions. | 3 Years |
| Rates of attrition for a prehabilitation program in elderly cystectomy patients. | Study attrition will be the rate at which patients drop out of the study. | 3 Years |
| Rates of adherence for a prehabilitation program in elderly cystectomy patients. | Study adherence will be the percentage of prescribed exercise sessions each participant completes during the treatment period. | 3 Years |
| Rates of accrual for a prehabilitation program in elderly cystectomy patients. | Track the study recruitment rate and, once patients have been screened by the study team and approached to participate, note the reasons that patients who choose not to participate give for their refusal (personal preference, medical comorbidities/deconditioning, perceived program intensity, time commitment for the study protocol, travel distance or lack of consistent means of travel). | 3 Years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |