Mackie Paul, Crowfoot Gary, Janssen Heidi, Dunstan David W, Bernhardt Julie, Walker F Rohan, Patterson Amanda, Callister Robin, Spratt Neil J, Holliday Elizabeth, English Coralie
School of Health Sciences, University of Newcastle, NSW, Australia.
Priority Research Centre for Stroke and Brain Injury, University of Newcastle and Hunter Medical Research Institute, NSW, Australia.
Contemp Clin Trials Commun. 2018 Dec 2;13:100310. doi: 10.1016/j.conctc.2018.100310. eCollection 2019 Mar.
Excessive sitting is detrimentally associated with cardiovascular disease and all-cause mortality. Frequent breaks in prolonged sitting can improve cardiometabolic responses in non-stroke populations. However, this has not been established in stroke survivors. This study will determine the most effective dose of activity breaks that (i) produce clinically meaningful improvements in mean systolic blood pressure (primary outcome), postprandial glucose, and insulin responses (secondary outcomes), and (ii) is safe and feasible. We hypothesis that systolic blood pressure, postprandial insulin, and glucose responses will improve with increasing doses of activity and be most effective at the maximum safe and feasible dose of activity. Thirty participants in the most effective dose will provide 80% power to detect a within-person, between-condition, difference of 3.5 mmHg in systolic blood pressure assuming a SD of 15 mmHg, within-person correlation of 0.9, and α = 0.05. Stroke survivors will complete 3 experimental conditions in a within-participant, dose escalation design including (i) uninterrupted sitting (8 h), (ii) Dose 1: uninterrupted sitting with bouts of light-intensity exercises while standing (initial dose involves two 5-min breaks), and (iii) Dose 2: two additional 5-min breaks above Dose 1. Ambulatory blood pressure will be collected every 30 min during experimental conditions and hourly for 24-h post-experimental conditions. Blood samples will be collected every 30 min during 2-h postprandial periods. This study will identify the most effective dose of light-intensity exercises while standing to improve cardiometabolic responses in stroke survivors.
久坐与心血管疾病及全因死亡率存在有害关联。在久坐期间频繁休息可改善非中风人群的心脏代谢反应。然而,这在中风幸存者中尚未得到证实。本研究将确定活动休息的最有效剂量,该剂量要满足以下两点:一是能使平均收缩压(主要结局)、餐后血糖和胰岛素反应(次要结局)产生具有临床意义的改善;二是安全可行。我们假设随着活动剂量增加,收缩压、餐后胰岛素和血糖反应会得到改善,且在最大安全可行剂量时效果最为显著。若假定标准差为15 mmHg、个体内相关性为0.9且α = 0.05,那么参与最有效剂量研究的30名参与者将有80%的把握检测到个体内、不同条件下收缩压3.5 mmHg的差异。中风幸存者将在个体内剂量递增设计中完成3种实验条件,包括:(i)不间断久坐(8小时);(ii)剂量1:不间断久坐并伴有站立时的轻度运动(初始剂量包括两次5分钟的休息);(iii)剂量2:在剂量1的基础上再增加两次5分钟的休息。在实验条件期间,每30分钟收集一次动态血压,实验条件结束后24小时内每小时收集一次。在餐后2小时内,每30分钟采集一次血样。本研究将确定站立时轻度运动的最有效剂量,以改善中风幸存者的心脏代谢反应。