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将在其一生中出现两种较低的尿路症状，大多数 将归因于良性前列腺增生（LUTS/BPH）。患有LUTS/BPH的老年人的风险增加 建立新的流动性限制，跌倒，断裂，残疾和死亡。不幸的是，当前的luts/bph 以前列腺为中心机制的药物可能会进一步增加其中一些晚期临床的风险 结果，效率适中，依从性差。与脆弱的机制是新颖的LUTS/BPH 可以通过运动干预可以预防或修改的干预目标。我们的团队有 以前创建了一个基于良好的个性化，远程监控和基于家庭的锻炼计划 已知的行为改变原则和可扩展干预措施的优先级，需要最少的设备 患有前列腺癌的老年男性。但是，需要进行试点研究以确定可行性和最佳试验 在具有LUTS/BPH的身体不活跃的老年男性中测试这种运动干预的设计。 因此，我们提出了68名身体不活跃的老年人中的单中心飞行员随机对照试验 与12周的多组分运动干预与健康教育控制的LUTS/BPH。这 运动干预包括有关有氧和抵抗的个性化书面和图形说明 练习，由每周通过电话或视频通话以及心率监视器的每周一对一教练支持 生物反馈和提供有限设备的提供。进行以下目标必须在进行之前解决 充分动力的效率试验：目标1：评估一个可行性，可接受性，忠诚度和安全性 远程运动干预和健康教育控制与LUTS/BPH的身体不活跃的老年人 （n = 68总计）34/ARM）; AIM 2：评估LUTS，泌尿科和泌尿外科变化的大小，可变性和耐用性 进行12周的运动干预或健康教育控制后的身体功能和行为措施； 目标3：评估检测新型脆弱机械变化的可行性 度量（总肌肉质量，线粒体功能，尿液α1-微球蛋白）。这个项目是创新的 因为它利用多个器官的偏远运动干预具有多余的和全身效果 与现有的以前列腺为中心的药物和外科手术疗法相比，系统与副作用相比 对于避免老年人至关重要。我们的项目将完成所需的广泛可行性工作 未来的效率试验和与脆弱的机械生物标志物测量。 这项试点研究是迈向延长，全功率效率试验的重要一步，次要焦点 关于治疗LUTS/BPH的运动干预措施的较大机制。这个未来的效率试验有 转化具有LUTS/BPH的身体不活跃的老年男性的潜力 同样，我们对运动如何影响与脆弱的LUTS/BPH机制的理解相同。