Sit Less, Interact and Move More (SLIMM) 2 Study

少坐、多互动、多活动 (SLIMM) 2 研究

• 批准号: 10404119
• 负责人: SRINIVASAN BEDDHU
• 金额: $ 66.65万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-15 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10404119
• 关键词: Accelerometer; Adherence; Agonist; American; Attenuated; Basal metabolic rate; Behavior Therapy; Body Weight decreased; Body fat; Cardiovascular Diseases; Chronic Disease; Chronic Kidney Failure; Complex; Consensus; Data; Diabetes Mellitus; Energy Metabolism; Failure; Fatigue; Fatty acid glycerol esters; Funding; GLP-I receptor; Goals; Impairment; Inflammation; Institution; Insulin Resistance; Intervention; Lead; Lower Extremity; Measures; Metabolic; Muscle function; National Institute of Diabetes and Digestive and Kidney Diseases; Obesity; Oral; Overweight; Oxidative Stress; Participant; Patient Outcomes Assessments; Performance; Persons; Physical Function; Physical activity; Pilot Projects; Placebos; Positioning Attribute; Posture; Quality of life; Randomized Controlled Trials; Renal function; Research Personnel; Risk Factors; Sleep; Testing; Walking; Well in self; base; electric impedance; experience; feasibility testing; health related quality of life; improved; inflammatory marker; innovation; intervention effect; microRNA biomarkers; mortality; multidisciplinary; muscle form; novel; obese patients; physical inactivity; placebo group; primary endpoint; primary outcome; protein biomarkers; psychologic; secondary endpoint; secondary outcome; sedentary; sedentary activity; sedentary lifestyle; standard of care; strength training; successful intervention; vigorous intensity

Sedentary behavior is engaging in activities in the seated or lying position that barely raise the energy expenditure above the resting metabolic rate and is a risk factor for obesity, diabetes, cardiovascular disease and mortality. However, it is unlikely that moderate/ vigorous intensity physical activities could be an effective replacement for sedentary activities for persons with CKD as most otherwise healthy Americans do not even reach the current goals for these activities. Therefore, in a NIDDK funded pilot and feasibility RCT (R21DK106574, PI: Beddhu), we tested, the feasibility of a `Sit Less, Interact, Move More (SLIMM)' intervention to replace sedentary activities with casual stepping activities in 106 participants with CKD. In the SLIMM group, the maximum decrease in sedentary duration (-43.0, 95% CI --69.0 to -17.0 min/day) and increase in stepping duration (15.5, 95% CI 6.9 to 24.1 min/day) and the number of steps/day (1265, 95% CI 518 to 2012) were seen at week 20 but attenuated at week 24. In post-hoc, descriptive analyses, higher baseline physical function as evidenced by 6-min walk distance and lower baseline body fat% measured by bio-impedance appeared to be associated with achieving SLIMM intervention goals in the SLIMM group. Based on our observations in the SLIMM pilot study, we propose a complex interplay between sedentary behavior, impaired physical function and obesity that leads to a vicious cycle that perpetuates sedentary behavior in CKD. Therefore, a successful intervention for sedentary behavior will need to incorporate co- interventions targeting obesity and impaired physical function. Specifically, we propose the addition of guided resistance training to increase physical function and semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist that has been shown to decrease adiposity and inflammation and improve health related quality of life. Herein we seek to implement SLIMM intervention alone for the first three months followed by a 9 month RCT of three equal groups of SLIMM + standard of care RT + placebo, SLIMM + guided RT + placebo and SLIMM + guided RT + oral semaglutide in 156 overweight or obese patients with moderate to advanced CKD. The designated primary endpoint is decrease in sedentary duration and the key secondary endpoint is six- minute walk distance. We will also explore the effects of the interventions on body-fat%, patient reported outcomes, lower extremity performance battery and markers of inflammation. There is a large pool of potential participants in the two institutions. The study is adequately powered to detect meaningful decrease in sedentary duration and other endpoints. This multi-disciplinary team of experienced investigators have a proven track record of successfully conducting RCTs. This proposal is feasible, innovative, and likely to yield results that will be informative. If the interventions decrease sedentary behavior in CKD, this trial will pave the way for larger RCTs of sedentary behavior interventions on hard endpoints.

久坐行为是指以坐姿或卧姿从事几乎无法提高能量的活动 支出高于静息代谢率，是肥胖、糖尿病、心血管疾病的危险因素 和死亡率。然而，中等/剧烈强度的身体活动不太可能是有效的 替代慢性肾病患者的久坐活动，因为大多数健康的美国人甚至不这样做 达到这些活动的当前目标。因此，在 NIDDK 资助的试点和可行性随机对照试验中 （R21DK106574，PI：Beddhu），我们测试了“少坐、互动、多动（SLIMM）”的可行性 对 106 名 CKD 参与者进行干预，以休闲踏步活动代替久坐活动。在 SLIMM 组，久坐时间的最大减少量（-43.0，95% CI --69.0 至 -17.0 分钟/天）和 步行持续时间（15.5，95% CI 6.9 至 24.1 分钟/天）和步数/天（1265，95% CI 518 至 2012）在第 20 周出现，但在第 24 周减弱。在事后描述性分析中，较高 通过 6 分钟步行距离证明的基线身体机能以及通过以下方法测量的较低基线身体脂肪百分比 在 SLIMM 组中，生物阻抗似乎与实现 SLIMM 干预目标相关。 根据我们在 SLIMM 试点研究中的观察，我们提出久坐不动之间存在复杂的相互作用 行为、身体机能受损和肥胖，导致久坐的恶性循环 CKD 中的行为。因此，对久坐行为的成功干预需要结合以下因素： 针对肥胖和身体机能受损的干预措施。具体来说，我们建议添加引导 抗阻训练可增强身体机能和索马鲁肽（一种胰高血糖素样肽-1 (GLP-1) 受体） 激动剂已被证明可以减少肥胖和炎症并改善与健康相关的生活质量。 在此，我们寻求在前三个月单独实施 SLIMM 干预，随后是 9 个月 SLIMM + 标准护理 RT + 安慰剂、SLIMM + 引导 RT + 安慰剂三组的随机对照试验 SLIMM + 引导 RT + 口服索马鲁肽治疗 156 名超重或肥胖的中度至晚期 CKD 患者。 指定的主要终点是久坐时间的减少，关键的次要终点是六- 分钟步行距离。患者报告称，我们还将探讨干预措施对体脂百分比的影响 结果、下肢性能电池和炎症标志物。 这两个机构都有大量的潜在参与者。该研究有足够的动力 检测久坐时间和其他终点的有意义的减少。这个多学科团队 经验丰富的研究人员拥有成功开展随机对照试验的良好记录。这个提议是 可行、创新，并且可能产生信息丰富的结果。如果干预措施减少 CKD 的久坐行为，这项试验将为针对久坐行为干预的更大的随机对照试验铺平道路 硬端点。