Preventing a Decline in Physical Function in Older Androgen-Deprived Men with Structured Exercise Training

通过结构化运动训练预防雄激素缺乏的老年男性身体机能下降

基本信息

批准号：
10090555
负责人：
Shehzad Basaria
金额：
$ 23.03万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-02-01 至 2023-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10090555
关键词：
Activities of Daily Living Adverse effects Age Aggressive course Agonist American Androgen Suppression Androgens Attention Attenuated Body Composition Body Weight Castration Clinical Control Groups Cross-Sectional Studies Dual-Energy X-Ray Absorptiometry Enrollment Ensure Equilibrium Etiology Exercise Exercise Therapy Exhibits Fatigue Fatty acid glycerol esters Functional disorder Goals Gonadotropin Hormone Releasing Hormone Health Hormones Intervention Intervention Trial Laboratories Lead Lower Extremity Maintenance Malignant Neoplasms Malignant neoplasm of prostate Measures Medical Castration Metastatic Prostate Cancer Methods Muscle Muscular Atrophy Orchiectomy Organ Outcome Patients Performance Phenotype Physical Function Physical Performance Prevention Prostate Prostate Cancer therapy Prostatectomy Public Health Quality of life Questionnaires Randomized Randomized Controlled Trials Regimen Reporting Role SF-36 Scanning Serum Standardization Structure Testosterone Thinness Time Tissues Training United States Upper Extremity Visit androgen deprivation therapy androgen sensitive attentional control comparative efficacy design efficacy evaluation exercise intervention exercise physiologist exercise regimen exercise training experience fall risk falls flexibility frailty health related quality of life high risk improved instrument lean body mass men muscle form muscle strength older men patient population preservation prevent primary outcome prospective randomized trial recruit reduced muscle strength resilience resistance exercise therapy design

项目摘要

PROJECT SUMMARY/ABSTRACT The overall goal of this proposal is to determine the efficacy of resistance exercise training in preventing the decline in physical function in men with prostate cancer (PCa) undergoing androgen deprivation therapy (ADT). As testosterone has a central role in the stimulation of prostate tissue, ADT is the cornerstone of treatment in men with high grade and metastatic PCa. ADT results in castrate levels of serum testosterone and this profound androgen deficiency leads to a reduction in lean mass and an increase in fat mass. These perturbations in body composition follow an aggressive course in these men as loss of lean mass is evident within 6-8 weeks of starting ADT. These unfavorable changes in body composition result in decreased muscle strength, which in turn, results in a decline in physical function. These adverse effects have serious consequences as men on ADT have a higher risk of frailty and falls compared with men with PCa who do not undergo ADT and are only treated with prostatectomy. Despite declines in these functional tasks that are patient-important and critical to maintenance of independence, not a single randomized trial has been performed in these men to evaluate the efficacy of a structured exercise regimen in preventing decline in physical function. A handful of previous studies had only enrolled men who were already receiving ADT and had already encountered significant muscle atrophy; therefore, as expected, no meaningful improvements in physical function were seen. Furthermore, previous studies did not provide equal attention to control groups. We propose a randomized, controlled, parallel group trial to determine the efficacy of 6-months of structured resistance exercise training in preventing the decline in physical function (assessed by loaded stair climbing power) in men age 60 years and older who are about to begin ADT for PCa. We will also provide equal attention to the control group using structured, patient-important, but outcome innocuous interventions (flexibility and balance exercises). We will also evaluate the efficacy of exercise training on muscle mass (DEXA scan), muscle strength (1RM method), QOL (SF-36 questionnaire) and fatigue (FACIT-F questionnaire). The findings of this trial will lay the groundwork for definitive intervention trials to prevent hard outcomes of frailty and falls in men undergoing ADT. As frailty imposes a significant public health burden and is associated with diminished functional capacity and resilience, the proposed trial is likely to have a substantial clinical impact in the overall health and independence of this patient population.

项目概要/摘要该提案的总体目标是确定阻力运动训练在预防接受雄激素剥夺疗法（ADT）的前列腺癌（PCa）男性身体机能下降。由于睾酮在刺激前列腺组织方面发挥着核心作用，因此 ADT 是治疗的基石。患有高级别和转移性前列腺癌的男性。 ADT 导致血清睾酮的去势水平，这严重的雄激素缺乏会导致瘦体重减少和脂肪量增加。这些这些男性的身体成分紊乱伴随着攻击性过程，因为瘦体重明显减少开始 ADT 后 6-8 周内。这些身体成分的不利变化会导致肌肉减少力量，进而导致身体机能下降。这些不良影响严重后果是，与未接受 ADT 治疗的前列腺癌患者相比，接受 ADT 治疗的男性出现虚弱和跌倒的风险更高接受 ADT 并且仅接受前列腺切除术治疗。尽管这些功能性任务有所下降患者对维持独立性至关重要且至关重要，但尚未有任何一项随机试验对这些男性进行了评估，以评估结构化锻炼方案在预防功能衰退方面的功效。身体机能。之前的一些研究只招募了已经接受 ADT 的男性，已经出现明显的肌肉萎缩；因此，正如预期的那样，没有任何有意义的改进身体机能都看到了。此外，之前的研究并没有对对照组给予同等的关注。我们提出了一项随机、对照、平行组试验来确定 6 个月结构化治疗的有效性防止身体机能下降的抗阻运动训练（通过负重楼梯评估）攀爬能力）适用于即将开始 ADT 治疗 PCa 的 60 岁及以上男性。我们还将提供使用结构化的、对患者重要但结果无害的干预措施对对照组给予同等关注（灵活性和平衡练习）。我们还将评估运动训练对肌肉质量的功效（DEXA 扫描）、肌力（1RM 方法）、QOL（SF-36 问卷）和疲劳（FACIT-F 问卷）。该试验的结果将为明确的干预试验奠定基础，以预防硬性病的发生。接受 ADT 的男性虚弱和跌倒的结果。由于虚弱给公共健康带来了巨大的负担与功能能力和恢复能力下降有关，拟议的试验可能会产生大量的影响对该患者群体的整体健康和独立性的临床影响。