Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Baseline Strength Test (Other)
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.
干预措施: Exercise (Other)
结局指标
主要结局
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.
时间窗: 3 Years
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.
次要结局
- 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)
- Rates of accrual for a prehabilitation program in elderly cystectomy patients.(3 Years)
研究者
Jeffrey Montgomery
Associate Professor, Urology
University of Michigan