Prescription exercise for Older men with Urinary Disease (PROUD) pilot study

患有泌尿系统疾病的老年男性的处方练习（PROUD）试点研究

• 批准号: 10639885
• 负责人: Scott Ryan Bauer
• 金额: $ 34.25万
• 依托单位: NORTHERN CALIFORNIA INSTITUTE/RES/EDU
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10639885
• 关键词: Address; Adherence; Adrenergic alpha-Antagonists; Aerobic Exercise; Affect; Aging; American; Behavioral; Benign Prostatic Hypertrophy; Biofeedback; Biological Markers; Cardiovascular Diseases; Cessation of life; Clinical; Clinical Research; Clinical Trials; Diabetes Mellitus; Disease; Enrollment; Equipment; Erectile dysfunction; Exercise; Exercise Test; Feedback; Foundations; Fracture; Functional disorder; Future; Goals; Health; Health education; Home; Impairment; Instruction; International; Intervention; Interview; Laboratories; Malignant neoplasm of prostate; Measurement; Measures; Mission; Mitochondria; National Institute of Diabetes and Digestive and Kidney Diseases; Operative Surgical Procedures; Outcome; Participant; Performance; Persons; Pharmaceutical Preparations; Phenotype; Physical Function; Physical activity; Physiological; Pilot Projects; Prostate; Protocols documentation; Public Health; Publishing; Quality of life; Randomized, Controlled Trials; Research; Risk; Safety; Severities; Structure; Symptoms; Testing; Theory of Change; Urine; Urologic Diseases; Walking; Work; Writing; actigraphy; adherence rate; alpha-1-microglobulin; arm; body system; clinical care; disability; efficacy trial; exercise intervention; exercise prescription; exercise program; experience; falls; frailty; heart rate monitor; improved; innovation; lower urinary tract symptoms; male; men; mitochondrial dysfunction; muscle form; novel; older men; pharmacologic; physical inactivity; pilot trial; prevent; primary outcome; programs; remote monitoring; resistance exercise; response; retention rate; safety outcomes; sample collection; secondary outcome; side effect; telephone coaching; therapy design; treatment arm; trial design; urinary; urologic; video chat

PROJECT SUMMARY/ABSTRACT One in 3 American men will develop bothersome lower urinary tract symptoms in their lifetime, and the majority will be attributed to benign prostatic hyperplasia (LUTS/BPH). Older men with LUTS/BPH have increased risk of developing new mobility limitations, falls, fractures, disability, and death. Unfortunately, current LUTS/BPH medications targeting prostate-centric mechanisms likely further increase risk of some of these adverse clinical outcomes, have modest efficacy, and poor adherence. Frailty-related mechanisms are novel LUTS/BPH intervention targets that may be preventable or modifiable via an exercise intervention. Our team has previously created an individualized, remotely-monitored, and home-based exercise program based on well- known behavioral change principles and prioritization of scalable interventions requiring minimal equipment for older men with prostate cancer. However, a pilot study is required to determine the feasibility and optimal trial design for testing this exercise intervention in physically inactive older men with LUTS/BPH. We therefore propose a single-center pilot randomized controlled trial among 68 physically inactive older men with LUTS/BPH of a 12-week multicomponent exercise intervention versus health education control. The exercise intervention includes personalized written and pictorial instructions on aerobic and resistance exercises, supported by weekly one-on-one coaching by phone or video call, along with heart rate monitor biofeedback and the provision of limited equipment. The following aims must be addressed prior to conducting an adequately powered efficacy trial: Aim 1: Evaluate the feasibility, acceptability, fidelity, and safety of a remote exercise intervention and health education control among physically inactive older men with LUTS/BPH (N=68 total) 34/arm); Aim 2: Assess the magnitude, variability, and durability of changes in LUTS, urologic and physical function, and actigraphy measures after a 12-week exercise intervention or health education control; and Aim 3: Assess the feasibility of detecting exercise-induced change in novel frailty-related mechanistic measures (total muscle mass, mitochondrial function, urine α1-microglobulin). This project is innovative because it leverages a remote exercise intervention with pleotropic and systemic effects across multiple organ systems, in contrast to existing prostate-centric pharmacological and surgical therapies with side effects that are critical to avoid in older men. Our project will accomplish the extensive feasibility work that is required for both a future efficacy trial and the frailty-related mechanistic biomarker measurements. This pilot study is an important step towards an extended, fully-powered efficacy trial with a secondary focus on frailty-related mechanisms of an exercise intervention for treating LUTS/BPH. This future efficacy trial has the potential to transform both the clinical care for physically inactive older men with LUTS/BPH while simultaneously increasing our understanding of how exercise affects frailty-related LUTS/BPH mechanisms.

项目摘要/摘要 三分之一的美国男性会在一生中出现令人烦恼的下尿路症状，而且大多数人 将归因于良性前列腺增生症(LUTS/BPH)。患有LUTS/BPH的老年男性风险增加 出现新的活动受限、跌倒、骨折、残疾和死亡。不幸的是，目前的LUTS/BPH 针对以前列腺为中心的机制的药物可能会进一步增加某些不良临床风险 结果，疗效不佳，依从性差。与脆弱性相关的机制是新的LUTS/BPH 可通过运动干预预防或修改的干预目标。我们队有 之前创建了一个个性化的、远程监控的、基于家庭的锻炼计划 已知的行为改变原则和可扩展干预的优先顺序，需要最少的设备 患有前列腺癌的老年男性。然而，需要进行试点研究，以确定可行性和最佳试验 在患有LUTS/BPH的不活跃的老年男性中测试这种运动干预的设计。 因此，我们建议在68名不活跃的老年男性中进行一项单中心试点随机对照试验 对LUTS/BPH进行为期12周的多组分运动干预与健康教育对照。这个 运动干预包括关于有氧和阻力的个性化书面和图片指导 每周通过电话或视频电话进行一对一指导，并配有心率监测器 生物反馈和提供有限的设备。在实施之前，必须实现以下目标 一项动力充足的疗效试验：目标1：评估一种 运动不活跃老年男性下尿路综合征/前列腺增生症的远程运动干预及健康教育控制 (n=68)34/ARM)；目标2：评估LUTS、泌尿科和尿路系统的变化的幅度、可变性和持久性 在12周的运动干预或健康教育对照后，进行身体功能和动作测量； 目标3：评估在新的脆弱相关机制中检测运动诱导变化的可行性 检测指标(总肌量、线粒体功能、尿α-1-微球蛋白)。该项目具有创新性。 因为它利用远程运动干预，对多个器官产生多发性和全身性影响 系统，与现有的以前列腺为中心的药物和手术疗法相比，副作用是 是老年男性应该避免的关键因素。我们的项目将完成所需的广泛的可行性工作 未来的疗效试验和与脆弱相关的机械生物标记物测量。 这项先导性研究是朝着扩展的、全功率的疗效试验迈出的重要一步，并具有次要的重点。 运动干预治疗下尿路综合征/前列腺增生症的虚弱相关机制研究这项未来的疗效试验 改变对患有LUTS/BPH的非运动老年男性的临床护理的潜力 同时，增加了我们对运动如何影响虚弱相关的LUTS/BPH机制的理解。