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.

项目总结/摘要 三分之一的美国男性在其一生中会出现令人烦恼的下尿路症状，大多数 将归因于良性前列腺增生（LUTS/BPH）。患有LUTS/BPH的老年男性风险增加 发展新的移动限制，福尔斯，骨折，残疾和死亡。不幸的是，目前的LUTS/BPH 针对前列腺中心机制的药物可能会进一步增加这些不良临床反应的风险。 结果，具有适度的功效，并且依从性差。虚弱相关机制是新的LUTS/BPH 可以通过运动干预预防或改变的干预目标。我们的团队已被 以前创建了一个个性化的，远程监控的，以家庭为基础的锻炼计划， 已知的行为改变原则和可扩展的干预措施的优先次序， 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 设计用于在患有LUTS/BPH的身体不活跃的老年男性中测试这种运动干预。 因此，我们提出了一个单中心的试点随机对照试验，在68个身体不活跃的老年男性 LUTS/BPH患者进行为期12周的多成分运动干预与健康教育对照。的 运动干预包括个性化的有氧和阻力的书面和图片说明 每周一次的电话或视频一对一指导，配合心率监测仪进行沿着锻炼 生物反馈和提供有限的设备。在开展以下活动之前，必须实现以下目标： 一个有充分把握度的疗效试验：目的1：评价一个有充分把握度的疗效试验的可行性、可接受性、保真度和安全性。 远程运动干预和健康教育控制对不爱运动的老年男性下尿路症状/前列腺增生的影响 （共N=68例）34例/组）;目的2：评估LUTS、泌尿系统和 12周运动干预或健康教育对照后的身体功能和腕动计测量; 目的3：评估检测运动引起的新的脆弱相关机制变化的可行性。 测量（总肌肉质量、线粒体功能、尿α1-微球蛋白）。这个项目是创新的 因为它利用了远程运动干预，对多个器官产生多效和全身效应， 系统，与现有的以前列腺为中心的药物和手术治疗相比， 是老年男性必须避免的我们的项目将完成广泛的可行性工作， 未来的疗效试验和虚弱相关的机械生物标志物测量。 这项初步研究是迈向扩展的、完全有效的疗效试验的重要一步， 运动干预治疗LUTS/BPH的脆弱相关机制。这项未来的疗效试验 有可能改变对患有LUTS/BPH的身体不活跃的老年男性的临床护理， 同时增加我们对运动如何影响与虚弱相关的LUTS/BPH机制的理解。