The Sit Less, Interact and Move More (SLIMM-2) Trial: Protocol for a randomized control trial of a sedentary behavior intervention, resistance training and semaglutide on sedentary behavior in persons with chronic kidney disease

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-01 DOI:10.1016/j.cct.2024.107766

Jesse C. Christensen , Shuchi Anand , Glenn M. Chertow , Kate Lyden , Amara Sarwal , Terrence Bjordahl , Robert Boucher , Azeem Mohammed , Evan G. Oro , Farahnaz Akramimoghaddam , Niharika Katkam , Augustine Takyi , George Bissada , Akhil Ramanujam Chakravartula , Edison Lee , Ann Zheng , Guo Wei , Tom Greene , Srinivasan Beddhu

{"title":"The Sit Less, Interact and Move More (SLIMM-2) Trial: Protocol for a randomized control trial of a sedentary behavior intervention, resistance training and semaglutide on sedentary behavior in persons with chronic kidney disease","authors":"Jesse C. Christensen , Shuchi Anand , Glenn M. Chertow , Kate Lyden , Amara Sarwal , Terrence Bjordahl , Robert Boucher , Azeem Mohammed , Evan G. Oro , Farahnaz Akramimoghaddam , Niharika Katkam , Augustine Takyi , George Bissada , Akhil Ramanujam Chakravartula , Edison Lee , Ann Zheng , Guo Wei , Tom Greene , Srinivasan Beddhu","doi":"10.1016/j.cct.2024.107766","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Sedentary behavior is highly prevalent and associated with morbidity and mortality in chronic kidney disease (CKD). A Sit Less, Interact and Move More (SLIMM) sedentary activity coaching intervention can reduce sedentary duration among persons with CKD, but preliminary data suggest that effects may not persist. Prior studies have suggested that moderate/vigorous intensity physical activities are not sustainable in persons with CKD. Therefore, we aimed to determine whether guided resistance training ± oral semaglutide co-intervention improves adherence and/or persistence of the SLIMM intervention.</div></div><div><h3>Method/design</h3><div>The SLIMM-2 is a two-center study designed with a 3-month sedentary activity coaching (SLIMM) followed by a 9-month randomized controlled trial with three arms: SLIMM + standard of care resistance training + oral placebo, SLIMM + guided resistance training + oral placebo, or SLIMM + guided resistance training + oral semaglutide. The study is recruiting persons with CKD (eGFR 20 to ≤60 ml/min/1.73 m<sup>2</sup>). ActivPAL, a wearable tri-axial accelerometer, is used to assess outcomes including sedentary duration (primary outcome), stepping duration and the average number of steps per day. Additional outcomes include 6-min walk distance and body fat percentage. Persons randomized to standard of care resistance training will be encouraged to maintain individualized physical activity goals; those randomized to guided resistance training will attend guided sessions per month and be prescribed daily independent exercises.</div></div><div><h3>Results</h3><div>Enrollment, interventions, and follow-up are ongoing.</div></div><div><h3>Conclusions</h3><div>Results from the SLIMM-2 study are expected to inform clinical practice, with the potential to enhance physical health and functioning among persons with CKD.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107766"},"PeriodicalIF":2.0000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424003495","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Sedentary behavior is highly prevalent and associated with morbidity and mortality in chronic kidney disease (CKD). A Sit Less, Interact and Move More (SLIMM) sedentary activity coaching intervention can reduce sedentary duration among persons with CKD, but preliminary data suggest that effects may not persist. Prior studies have suggested that moderate/vigorous intensity physical activities are not sustainable in persons with CKD. Therefore, we aimed to determine whether guided resistance training ± oral semaglutide co-intervention improves adherence and/or persistence of the SLIMM intervention.

Method/design

The SLIMM-2 is a two-center study designed with a 3-month sedentary activity coaching (SLIMM) followed by a 9-month randomized controlled trial with three arms: SLIMM + standard of care resistance training + oral placebo, SLIMM + guided resistance training + oral placebo, or SLIMM + guided resistance training + oral semaglutide. The study is recruiting persons with CKD (eGFR 20 to ≤60 ml/min/1.73 m²). ActivPAL, a wearable tri-axial accelerometer, is used to assess outcomes including sedentary duration (primary outcome), stepping duration and the average number of steps per day. Additional outcomes include 6-min walk distance and body fat percentage. Persons randomized to standard of care resistance training will be encouraged to maintain individualized physical activity goals; those randomized to guided resistance training will attend guided sessions per month and be prescribed daily independent exercises.

Results

Enrollment, interventions, and follow-up are ongoing.

Conclusions

Results from the SLIMM-2 study are expected to inform clinical practice, with the potential to enhance physical health and functioning among persons with CKD.

查看原文本刊更多论文

少坐、多互动、多运动（slim -2）试验：慢性肾病患者久坐行为干预、阻力训练和西马鲁肽的随机对照试验方案。

背景：久坐行为在慢性肾脏疾病（CKD）中非常普遍，并与发病率和死亡率相关。少坐，多互动，多动（SLIMM）久坐活动指导干预可以减少CKD患者久坐时间，但初步数据表明效果可能不会持续。先前的研究表明，中度/剧烈强度的体育活动在慢性肾病患者中是不可持续的。因此，我们的目的是确定指导性抗阻训练±口服西马鲁肽联合干预是否能改善SLIMM干预的依从性和/或持久性。方法/设计：SLIMM-2是一项双中心研究，设计为3个月的久坐活动指导（SLIMM），随后是9个月的三组随机对照试验：SLIMM +标准护理抗阻训练+口服安慰剂，SLIMM +引导抗阻训练+口服安慰剂，或SLIMM +引导抗阻训练+口服西马鲁肽。该研究招募CKD患者（eGFR 20至≤60 ml/min/1.73 m2）。ActivPAL是一种可穿戴的三轴加速度计，用于评估结果，包括久坐时间（主要结果）、步行时间和每天的平均步数。其他结果包括6分钟步行距离和体脂率。随机分配到标准护理抗阻训练的人将被鼓励保持个性化的身体活动目标；那些随机分配到指导阻力训练组的人将每月参加指导课程，并规定每天进行独立练习。结果：入组、干预和随访正在进行中。结论：slim -2研究的结果有望为临床实践提供信息，具有增强CKD患者身体健康和功能的潜力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.