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

• 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
• 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

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最近的发现，我们证实了前列腺癌（PC） 接受雄激素剥夺治疗（ADT）的幸存者更容易跌倒， 比没有接受这种治疗的PC幸存者或没有癌症的男性更虚弱， 幸存者发生跌倒相关骨折、其他危及生命的伤害、残疾和死亡的风险更高。目前， 目前还没有专门针对ADT治疗的PC幸存者的循证跌倒预防策略。的 所提出的研究的目的是确定和比较两种非常不同类型的锻炼的功效， 太极与力量训练，以防止福尔斯特别与ADT前列腺癌。我们将研究 其他虚弱和身体功能终点，也会在ADT治疗后恶化，并导致风险 福尔斯和未来残疾的风险。我们提出了一个3组，单盲，平行设计，随机对照试验， 接受ADT治疗的PC幸存者（N=360），比较1）太极拳2）力量训练与3）安慰剂对照 一组坐姿伸展运动。男性将参加为期6个月的监督研究计划，每周3次， 将在正式训练结束后再随访6个月。本研究的具体目的是确定 并比较太极和力量训练两者的功效以1）减少福尔斯和2）减轻虚弱（萎缩， 虚弱、迟缓、疲惫和不活动）和PC功能障碍（活动、平衡、自我报告功能） ADT的幸存者，3）确定结构化培训后每种干预措施的益处是否持续 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 这项研究在方法上是创新的，因为它采用了两种特征鲜明的预防跌倒运动方案 (e.g.,太极和力量训练），以一个新的人口刚刚确定在高风险的福尔斯和谁 福尔斯的原因和有效的对策仍然不清楚。这项研究是第一次尝试直接 比较两种已知的锻炼方式，每一种都具有不同的训练特性，以减少福尔斯、虚弱和 PC幸存者的功能障碍。拟议的项目响应了癌症的紧急研究议程 生存，要求制定适当的有针对性的，有效的，可持续的锻炼计划， 癌症幸存者以及NCI和IOM的优先事项，以扩大癌症护理，防止老年幸存者残疾。 这项研究与公共卫生有关，因为美国200万例PCS中有45%是处方药 ADT。接受ADT治疗的男性可以存活16年或更长时间，延长了他们易受福尔斯、虚弱 以及衰老和癌症治疗带来的功能障碍，但目前还没有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、低成本的方法来解决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。如果实现了目标，就有一个有效的解决方案来防止福尔斯和 减少与ADT相关的虚弱将容易用于临床和康复实践。重要的是， 这项研究将解决NCI癌症登月计划的目标，以减少癌症的衰弱副作用。