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干预减少久坐行为作为冠心病患者个体化二级预防策略的有效性:SIT LESS 随机临床试验的主要结局。

Effectiveness of an intervention to reduce sedentary behaviour as a personalised secondary prevention strategy for patients with coronary artery disease: main outcomes of the SIT LESS randomised clinical trial.

机构信息

Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.

Department of Cardiology, Bernhoven Hospital, Uden, The Netherlands.

出版信息

Int J Behav Nutr Phys Act. 2023 Feb 14;20(1):17. doi: 10.1186/s12966-023-01419-z.

Abstract

BACKGROUND

A high sedentary time is associated with increased mortality risk. Previous studies indicate that replacement of sedentary time with light- and moderate-to-vigorous physical activity attenuates the risk for adverse outcomes and improves cardiovascular risk factors. Patients with cardiovascular disease are more sedentary compared to the general population, while daily time spent sedentary remains high following contemporary cardiac rehabilitation programmes. This clinical trial investigated the effectiveness of a sedentary behaviour intervention as a personalised secondary prevention strategy (SIT LESS) on changes in sedentary time among patients with coronary artery disease participating in cardiac rehabilitation.

METHODS

Patients were randomised to usual care (n = 104) or SIT LESS (n = 108). Both groups received a comprehensive 12-week centre-based cardiac rehabilitation programme with face-to-face consultations and supervised exercise sessions, whereas SIT LESS participants additionally received a 12-week, nurse-delivered, hybrid behaviour change intervention in combination with a pocket-worn activity tracker connected to a smartphone application to continuously monitor sedentary time. Primary outcome was the change in device-based sedentary time between pre- to post-rehabilitation. Changes in sedentary time characteristics (prevalence of prolonged sedentary bouts and proportion of patients with sedentary time ≥ 9.5 h/day); time spent in light-intensity and moderate-to-vigorous physical activity; step count; quality of life; competencies for self-management; and cardiovascular risk score were assessed as secondary outcomes.

RESULTS

Patients (77% male) were 63 ± 10 years and primarily diagnosed with myocardial infarction (78%). Sedentary time decreased in SIT LESS (- 1.6 [- 2.1 to - 1.1] hours/day) and controls (- 1.2 [ ─1.7 to - 0.8]), but between group differences did not reach statistical significance (─0.4 [─1.0 to 0.3]) hours/day). The post-rehabilitation proportion of patients with a sedentary time above the upper limit of normal (≥ 9.5 h/day) was significantly lower in SIT LESS versus controls (48% versus 72%, baseline-adjusted odds-ratio 0.4 (0.2-0.8)). No differences were observed in the other predefined secondary outcomes.

CONCLUSIONS

Among patients with coronary artery disease participating in cardiac rehabilitation, SIT LESS did not induce significantly greater reductions in sedentary time compared to controls, but delivery was feasible and a reduced odds of a sedentary time ≥ 9.5 h/day was observed.

TRIAL REGISTRATION

Netherlands Trial Register: NL9263. Outcomes of the SIT LESS trial: changes in device-based sedentary time from pre-to post-cardiac rehabilitation (control group) and cardiac rehabilitation + SIT LESS (intervention group). SIT LESS reduced the odds of patients having a sedentary time >9.5 hours/day (upper limit of normal), although the absolute decrease in sedentary time did not significantly differ from controls. SIT LESS appears to be feasible, acceptable and potentially beneficial, but a larger cluster randomised trial is warranted to provide a more accurate estimate of its effects on sedentary time and clinical outcomes. CR: cardiac rehabilitation.

摘要

背景

久坐时间过长与死亡风险增加有关。先前的研究表明,将久坐时间替换为低强度到高强度的身体活动可以降低不良后果的风险,并改善心血管危险因素。与一般人群相比,心血管疾病患者的久坐时间更长,而在接受当代心脏康复计划后,他们每天的久坐时间仍然很高。本临床试验研究了作为个性化二级预防策略的久坐行为干预(SIT LESS)对接受心脏康复的冠心病患者久坐时间变化的有效性。

方法

患者被随机分配至常规护理组(n=104)或 SIT LESS 组(n=108)。两组均接受为期 12 周的综合中心为基础的心脏康复计划,包括面对面咨询和监督运动,而 SIT LESS 组参与者还接受了为期 12 周、由护士提供的混合行为改变干预措施,结合佩戴在口袋中的活动追踪器与智能手机应用程序相连,以连续监测久坐时间。主要结局是康复前后基于设备的久坐时间变化。评估久坐时间特征的变化(长时间久坐的发生率和久坐时间≥9.5 小时/天的患者比例);轻强度和中等到剧烈身体活动的时间;步数;生活质量;自我管理能力;和心血管风险评分作为次要结局。

结果

患者(77%为男性)年龄为 63±10 岁,主要诊断为心肌梗死(78%)。SIT LESS 组(─1.6 [─2.1 至─1.1]小时/天)和对照组(─1.2 [ ─1.7 至─0.8]小时/天)的久坐时间均减少,但组间差异无统计学意义(─0.4 [─1.0 至 0.3]小时/天)。SIT LESS 组与对照组相比,康复后久坐时间超过正常上限(≥9.5 小时/天)的患者比例显著降低(48%对 72%,基于基线的优势比 0.4(0.2-0.8))。其他预定的次要结局没有观察到差异。

结论

在接受心脏康复的冠心病患者中,与对照组相比,SIT LESS 并没有显著降低久坐时间,但该方法是可行的,并且观察到久坐时间≥9.5 小时/天的可能性降低。

临床试验注册号

荷兰试验注册中心:NL9263。SIT LESS 试验的结局:从心脏康复前到后基于设备的久坐时间变化(对照组)和心脏康复+SIT LESS(干预组)。SIT LESS 降低了患者久坐时间超过 9.5 小时/天(正常上限)的几率(尽管与对照组相比,久坐时间的绝对减少没有显著差异)。SIT LESS 似乎是可行的、可接受的,并且可能是有益的,但需要更大的群组随机试验来更准确地估计其对久坐时间和临床结局的影响。CR:心脏康复。

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