Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, California, United States.
Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, California, United States.
Contemp Clin Trials. 2018 Nov;74:25-31. doi: 10.1016/j.cct.2018.09.003. Epub 2018 Sep 8.
The American Diabetes Association (ADA) currently recommends 150 min of moderate-intensity aerobic exercise per week and resistance exercise at least twice per week in individuals with type 2 diabetes (T2DM) to improve overall health [1]. However, approximately 38% of patients with T2DM do not exercise at recommended levels and 31% do not exercise at all [2]. The efficacy of structured exercise interventions has been proven effective in reducing glycosylated hemoglobin A1c (HbA1c) levels in patients, but practical approaches are needed to translate these findings into the clinical setting [3-7].
The Initiate and Maintain Physical Activity in Clinics (IMPACT) Study aims to compare structured group exercise within the clinic to usual care in T2DM patients. The main purpose of the study is to determine the optimal and feasible level and weekly frequency of structured contact in a clinical setting needed to initiate and maintain physical activity recommendations long-term.
IMPACT is a longitudinal, randomized-controlled study designed to track study participants over 30 months. Once study participants have met eligibility and enrollment criteria, they are randomized and enrolled into one of three arms: 1× per week exercise, 3× per week exercise, or the usual care control group. After randomization, participants begin Phase 1: Initiate lasting 6 months. Over the course of Phase 1, participants in the exercise groups will attend instructor led group training at a Stanford approved physical fitness facility. At the end of 6 months, participants enter Phase 2: Maintain lasting 24 months. Over the course of Phase 2, participants in all three arms will attend periodic follow-up visits for clinical measurements and survey administration for their final two years of participation. These findings will enable the clinical implementation of a structured exercise regimen designed to specifically address the aerobic and resistance training recommendations for patients with T2DM.
美国糖尿病协会（ADA）目前建议 2 型糖尿病（T2DM）患者每周进行 150 分钟中等强度的有氧运动和至少两次阻力运动，以改善整体健康状况[1]。然而，大约 38%的 T2DM 患者没有达到推荐的运动水平，31%的患者根本不运动[2]。结构运动干预的疗效已被证明可有效降低患者的糖化血红蛋白 A1c（HbA1c）水平，但需要切实可行的方法将这些发现转化为临床环境[3-7]。
在诊所开展并维持体力活动（IMPACT）研究旨在比较诊所内的结构性团体运动与 T2DM 患者的常规护理。该研究的主要目的是确定在临床环境中启动和维持体力活动推荐所需的最佳和可行的结构化接触水平和每周频率。
IMPACT 是一项纵向、随机对照研究，旨在对研究参与者进行 30 个月的跟踪研究。一旦研究参与者符合入选和入组标准，他们将被随机分为三组之一：每周运动 1 次、每周运动 3 次或常规护理对照组。随机分组后，参与者开始第 1 阶段：启动持续 6 个月。在第 1 阶段期间，运动组的参与者将在斯坦福认可的健身设施参加由指导员带领的团体培训。6 个月结束后，参与者进入第 2 阶段：维持持续 24 个月。在第 2 阶段期间，所有三组参与者都将参加定期随访，进行临床测量和调查管理，以完成他们最后两年的参与。这些发现将使临床实施一种结构化的运动方案成为可能，该方案旨在专门解决 T2DM 患者的有氧运动和抗阻训练建议。
