Krehbiel Lisa M, Layne Andrew S, Sandesara Bhanuprasad, Manini Todd M, Anton Stephen D, Buford Thomas W
University of Florida, Gainesville, FL.
Contemp Clin Trials Commun. 2017 Jun;6:122-126. doi: 10.1016/j.conctc.2017.04.003. Epub 2017 Apr 20.
Persons aged over 65 years account for over the vast majority of healthcare expenditures and deaths attributable to cardiovascular disease (CVD). Accordingly, reducing CVD risk among older adults is an important public health priority. Structured physical activity (i.e. exercise) is a well-documented method of decreasing CVD risk, but recent large-scale trials suggest that exercise alone is insufficient to reduce CVD events in high-risk populations of older adults. Thus adjuvant strategies appear necessary to reduce CVD risk. Accumulating evidence indicates that prolonged sedentary behavior (e.g. sitting) has detrimental health effects that are independent of engagement in recommended levels of moderate-intensity exercise. Yet clinical trials in this area are lacking. We hypothesize that exercise, when combined with a novel technology based intervention specifically designed to reduce sedentary behavior will reduce CVD risk among sedentary older adults. The purpose of this study is to evaluate the feasibility and efficacy of combining a traditional, structured exercise intervention with an innovative intervention designed to decrease sedentary behavior and increase non-exercise physical activity (NEPA). This study will provide us with critical data necessary to design and implement a full-scale trial to test our central hypothesis. Participants aged ≥60 years with moderate to high risk of coronary heart disease (CHD) events are randomly assigned to either the exercise and technology intervention (EX+NEPA) or exercise alone (EX) groups. Study dependent outcomes include changes in 1) daily activity patterns, 2) blood pressure, 3) exercise capacity, 4) waist circumference, and 5) circulating indices of cardiovascular function. This study will provide critical information for designing a fully-powered clinical trial, which could have health implications for the ever increasing population of older adults.
65岁以上的人群占心血管疾病(CVD)相关医疗支出和死亡人数的绝大多数。因此,降低老年人的心血管疾病风险是一项重要的公共卫生优先事项。有充分记录表明,有组织的体育活动(即运动)是降低心血管疾病风险的一种方法,但最近的大规模试验表明,仅靠运动不足以降低高危老年人群的心血管疾病事件。因此,辅助策略似乎对于降低心血管疾病风险是必要的。越来越多的证据表明,长时间久坐行为(如坐着)对健康有不利影响,且这种影响独立于适度强度运动的推荐水平。然而,该领域缺乏临床试验。我们假设,将运动与专门设计用于减少久坐行为的基于新技术的干预措施相结合,将降低久坐老年人群的心血管疾病风险。本研究的目的是评估将传统的、有组织的运动干预与旨在减少久坐行为和增加非运动身体活动(NEPA)的创新干预措施相结合的可行性和有效性。本研究将为我们提供设计和实施全面试验以检验我们的核心假设所需的关键数据。年龄≥60岁、冠心病(CHD)事件风险为中度至高度的参与者被随机分配到运动与技术干预(EX+NEPA)组或仅运动(EX)组。研究的相关结果包括以下方面的变化:1)日常活动模式;2)血压;3)运动能力;4)腰围;5)心血管功能的循环指标。本研究将为设计一项充分有力的临床试验提供关键信息,这可能对不断增加的老年人群体的健康产生影响。