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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要三分之一的美国男性在一生中会出现令人烦恼的下尿路症状，并且大多数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。不幸的是，目前的 LUTS/BPH 正在发生新的行动限制、跌倒、骨折、残疾和死亡。针对前列腺中心机制的药物可能会进一步增加其中一些不良临床的风险与衰弱相关的机制是新的 LUTS/BPH。我们的团队有可以通过运动干预来预防或改变的干预目标。之前创建了一个基于良好基础的个性化、远程监控和家庭锻炼计划已知的行为改变原则和可扩展干预措施的优先顺序，需要最少的设备然而，需要进行一项试点研究来确定可行性和最佳试验。设计用于在患有 LUTS/BPH 的缺乏运动的老年男性中测试这种运动干预。因此，我们建议在 68 名身体不活跃的老年男性中进行一项单中心试点随机对照试验 12 周多成分运动干预与健康教育控制的 LUTS/BPH。运动干预包括有关有氧运动和阻力的个性化书面和图片说明锻炼，每周通过电话或视频通话进行一对一辅导，并配备心率监测器生物反馈和提供有限的设备在进行之前必须解决以下目标。充分有力的功效试验：目标 1：评估试验的可行性、可接受性、保真度和安全性对患有 LUTS/BPH 的缺乏运动的老年男性进行远程运动干预和健康教育控制（总共 N=68）34 人/组）；目标 2：评估 LUTS、泌尿系统和 12周运动干预或健康教育控制后的身体功能和体动记录仪测量；目标 3：评估检测运动诱发的新型衰弱相关机制变化的可行性测量（总肌肉质量、线粒体功能、尿液 α1-微球蛋白）该项目具有创新性。因为它利用远程运动干预，对多个器官产生多效性和系统性影响系统，与现有的以前列腺为中心的药物和手术疗法相比，其副作用我们的项目将完成所需的广泛可行性工作。未来的功效试验和与虚弱相关的机械生物标志物测量。这项试点研究是迈向扩展、全面功效试验的重要一步，次要重点是这项未来的疗效试验研究了运动干预治疗 LUTS/BPH 的虚弱相关机制。有可能改变对患有 LUTS/BPH 的缺乏身体活动的老年男性的临床护理，同时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。