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Preventing Falls and Frailty in Prostate Cancer Survivors: GET FIT Prostate

预防前列腺癌幸存者跌倒和虚弱：GET FIT Prostate

基本信息

批准号：
9596188
负责人：
KERRI M WINTERS-STONE
金额：
$ 64.27万
依托单位：
OREGON HEALTH & SCIENCE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-23 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9596188
关键词：
Address Adverse effects Aging Androgens Cancer Survivor Cancer Survivorship Caring Cessation of life Clinical Clinical Treatment Communities Control Groups Drops Elderly Ensure Equilibrium Ethics Evidence based program Exercise Exposure to Fall prevention Fracture Functional disorder Future Goals Guidelines Health Health Benefit Incidence Injury Integration Host Factors Intervention Knowledge Lead Life Link Literature Malignant Neoplasms Malignant neoplasm of prostate Medical Care Costs Modality Morbidity - disease rate Muscular Atrophy Outcome Study Patient Self-Report Patient risk Patients Pattern Physical Function Placebo Control Placebos Population Prevalence Prevention program Prevention strategy Property Prostate Prostate Cancer therapy Provider Public Health Quality of life Randomized Controlled Trials Recommendation Rehabilitation therapy Reporting Research Risk Single-Blind Study Sleep Stretching Structure Supervision Survivors Tai Ji Testing Therapeutic Time Training Treatment Factor androgen deprivation therapy attentional control base cancer care cancer survival cancer therapy clinical practice comparative efficacy conventional therapy cost design disability efficacy trial evidence base exercise intervention exercise program exhaustion fall risk falls follow-up frailty head-to-head comparison high risk improved innovation insight men mode of exercise mortality muscle strength novel older men oncology patient oriented patient population placebo group prevent primary outcome programs secondary outcome strength training tumor

项目摘要

Based on recent findings from our team and others, we confirm initial reports that prostate cancer (PC) survivors treated with androgen deprivation therapy (ADT) are significantly more likely to fall and to become frail than PC survivors who do not receive this treatment or men without cancer, placing nearly half of all PC survivors at higher risk of fall-related fractures, other life-threatening injuries, disability and death. Currently, there are no evidence-based fall prevention strategies that specifically target PC survivors on ADT. The purpose of the proposed study is to determine and compare the efficacy of two very distinct types of exercise, tai chi versus strength training, to prevent falls specifically linked to ADT for prostate cancer. We will examine additional endpoints of frailty and physical function that are also worsened with ADT and contribute to the risk of falls and future disability. We propose a 3-group, single-blind, parallel design, randomized controlled trial in PC survivors treated with ADT (N=360) comparing 1) tai chi to 2) strength training against 3) a placebo control group of seated stretching exercise. Men will participate in supervised study programs 3x/wk for 6 months and will be followed for 6 more months after formal training stops. The specific aims of this study are to determine and compare the efficacy of both tai chi and strength training to 1) reduce falls and 2) lessen frailty (shrinking, weakness, slowness, exhaustion, and inactivity) and dysfunction (mobility, balance, self-report function) in PC survivors on ADT, 3) Determine whether or not the benefits of each intervention last after structured training stops and 4) Explore the patterns and predictors of men who respond best to each intervention. The proposed study is innovative in its approach because it applies two well-characterized fall prevention exercise programs (e.g., tai chi and strength training) to a new population just recently identified at high risk of falls and for whom the causes of falls and effective countermeasures remain unclear. This study is the very first attempt at a direct comparison of two known exercise modalities, each with distinct training properties, to reduce falls, frailty and dysfunction in PC survivors. The proposed project responds to an urgent research agenda in cancer survivorship that calls for developing appropriately targeted, effective, and sustainable exercise programs for cancer survivors and to NCI and IOM priorities to expand cancer care to prevent disability in older survivors. This study is relevant to public health because up to 45% of the 2 million PCS alive in the U.S. are prescribed ADT. Men on ADT can survive 16 years or longer, lengthening the time they grow susceptible to falls, frailty and dysfunction from aging and cancer treatment, yet there are no evidence-based therapeutic treatment options for these men. This study addresses this significant barrier in clinical practice by proposing a safe, low- cost, and scalable exercise-based approach. If the aims are achieved, an effective solution to prevent falls and reduce frailty associated with ADT will be readily available to clinical and rehabilitative practice. Importantly, this study would address a NCI Cancer MoonshotSM goal to reduce cancer's debilitating side effects.

根据我们团队和其他人的最新发现，我们确认了前列腺癌 (PC) 的初步报告接受雄激素剥夺疗法（ADT）治疗的幸存者明显更有可能跌倒并成为比未接受这种治疗的 PC 幸存者或未患癌症的男性更虚弱，近一半的 PC 幸存者发生跌倒相关骨折、其他危及生命的伤害、残疾和死亡的风险较高。现在，没有专门针对 ADT 中 PC 幸存者的基于证据的跌倒预防策略。这拟议研究的目的是确定并比较两种截然不同的运动类型的功效，太极拳与力量训练，以防止跌倒，特别与治疗前列腺癌的 ADT 相关。我们将检查虚弱和身体功能的其他终点也会因 ADT 而恶化并增加风险跌倒和未来残疾。我们提出了一项 3 组、单盲、平行设计、随机对照试验使用 ADT 治疗的 PC 幸存者 (N=360) 将 1) 太极拳与 2) 力量训练与 3) 安慰剂对照进行比较一组坐姿伸展运动。男性将参加每周 3 次的监督学习项目，为期 6 个月正式训练停止后将继续跟踪6个月。本研究的具体目的是确定并比较太极拳和力量训练的功效：1）减少跌倒，2）减轻虚弱（缩小， PC 中的虚弱、缓慢、疲惫和不活动）和功能障碍（活动性、平衡性、自我报告功能） ADT 幸存者，3) 确定每次干预的益处在结构化培训后是否持续 4) 探索对每种干预措施反应最好的男性的模式和预测因素。拟议的该研究的方法具有创新性，因为它应用了两种特征明确的预防跌倒锻炼计划（例如太极拳和力量训练）针对最近刚刚确定的跌倒高风险人群以及针对哪些人群跌倒原因和有效对策尚不清楚。这项研究是直接研究的首次尝试比较两种已知的运动方式，每种方式都有不同的训练特性，以减少跌倒、虚弱和 PC幸存者的功能障碍。拟议的项目响应了癌症领域的紧急研究议程生存要求制定适当有针对性的、有效的和可持续的锻炼计划癌症幸存者以及 NCI 和 IOM 优先考虑扩大癌症护理，以防止老年幸存者残疾。这项研究与公共卫生相关，因为美国 200 万 PCS 中高达 45% 的患者都服用了处方药 ADT。接受 ADT 的男性可以存活 16 年或更长时间，从而延长了他们容易跌倒、虚弱的时间以及衰老和癌症治疗带来的功能障碍，但尚无基于证据的治疗方法这些人的选择。这项研究通过提出一种安全、低剂量的方法解决了临床实践中的这一重大障碍。成本和可扩展的基于练习的方法。如果目标实现，就会有有效的解决方案来防止跌倒和减少与 ADT 相关的衰弱将很容易用于临床和康复实践。重要的是，这项研究将实现 NCI Cancer MoonshotSM 的目标，即减少癌症的衰弱副作用。