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生活方式干预和慢性阻塞性肺疾病(COPD)中的超重问题:INSIGHT COPD 随机临床试验。

Lifestyle Intervention and Excess Weight in Chronic Obstructive Pulmonary Disease (COPD): INSIGHT COPD Randomized Clinical Trial.

机构信息

Health Services Research and Development, Veterans Affairs Puget Sound Healthcare System, Seattle Division, Seattle, Washington.

Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, Washington.

出版信息

Ann Am Thorac Soc. 2023 Dec;20(12):1743-1751. doi: 10.1513/AnnalsATS.202305-458OC.

DOI:10.1513/AnnalsATS.202305-458OC
PMID:37769182
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10704228/
Abstract

Being overweight or obese is common among patients with chronic obstructive pulmonary disease (COPD), but whether interventions targeted at weight loss improve functional impairments is unknown. INSIGHT (Intervention Study in Overweight Patients with COPD) tested whether a pragmatic low-intensity lifestyle intervention would lead to better physical functional status among overweight or obese participants with COPD. The trial was a 12-month, multicenter, patient-level pragmatic clinical trial. Participants were recruited from April 2017 to August 2019 from 38 sites across the United States and randomized to receive usual care or usual care plus lifestyle intervention. The intervention was a self-directed video program delivering the Diabetes Prevention Program's Group Lifestyle Balance curriculum. The primary outcome was 6-minute-walk test distance at 12 months. Priority secondary outcomes were postwalk modified Borg dyspnea at 12 months and weight at 12 months. Participants ( = 684; mean age, 67.0 ± 8.0 yr [standard deviation]; 41.2% female) on average were obese (body mass index, 33.0 ± 4.6 kg/m) with moderate COPD (forced expiratory volume in 1 second % predicted, 58.1 ± 15.7%). At 12 months, participants randomized to the intervention arm walked farther (adjusted difference, 42.3 ft [95% confidence interval (CI), 7.9-76.7 ft];  = 0.02), had less dyspnea at the end of the 6-minute-walk test (adjusted difference, -0.36 [95% CI, -0.63 to -0.09];  = 0.008), and had greater weight loss (adjusted difference, -1.34 kg [95% CI, -2.33 to -0.34 kg];  = 0.008) than control participants. The intervention did not improve the odds of achieving clinically meaningful thresholds of walk distance (98.4 ft) or dyspnea (1 unit) but did achieve meaningful thresholds of weight loss (3% and 5%). Among participants with COPD who were overweight or obese, a self-guided low-intensity video-based lifestyle intervention led to modest weight loss but did not lead to clinically important improvements in physical functional status and dyspnea. Clinical trial registered with www.clinicaltrials.gov (NCT02634268).

摘要

超重或肥胖在慢性阻塞性肺疾病(COPD)患者中很常见,但针对减肥的干预措施是否能改善功能障碍尚不清楚。INSIGHT(超重 COPD 患者干预研究)测试了一种实用的低强度生活方式干预是否会改善超重或肥胖 COPD 患者的身体功能状态。该试验是一项为期 12 个月、多中心、患者水平的实用临床研究。参与者于 2017 年 4 月至 2019 年 8 月期间从美国 38 个地点招募,并随机分为接受常规护理或常规护理加生活方式干预组。干预措施是一个自我指导的视频项目,提供糖尿病预防计划的团体生活平衡课程。主要结局是 12 个月时的 6 分钟步行测试距离。重点次要结局是 12 个月时的步行后改良 Borg 呼吸困难和 12 个月时的体重。共有 684 名参与者(平均年龄 67.0±8.0 岁[标准差];41.2%为女性),平均肥胖(体重指数 33.0±4.6kg/m),患有中度 COPD(第 1 秒用力呼气量占预计值的百分比,58.1±15.7%)。12 个月时,干预组参与者步行距离更远(调整差异,42.3 英尺[95%置信区间(CI),7.9-76.7 英尺];=0.02),6 分钟步行测试结束时呼吸困难程度更低(调整差异,-0.36[95%CI,-0.63 至 -0.09];=0.008),体重减轻更多(调整差异,-1.34 公斤[95%CI,-2.33 至 -0.34 公斤];=0.008)比对照组参与者。该干预措施并未提高达到步行距离(98.4 英尺)或呼吸困难(1 个单位)的临床有意义阈值的几率,但确实达到了有意义的体重减轻阈值(3%和 5%)。在超重或肥胖的 COPD 患者中,自我引导的低强度基于视频的生活方式干预导致适度的体重减轻,但并未导致身体功能状态和呼吸困难的临床重要改善。临床试验在 www.clinicaltrials.gov 注册(NCT02634268)。

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