School of Health Sciences, College of Health, Medicine and Wellbeing, University of Newcastle, Newcastle, NSW, Australia; Heart and Stroke Program, Hunter Medical Research Institute, NSW, Australia.
College of Health, Medicine and Wellbeing, University of Newcastle, Newcastle, NSW, Australia; Heart and Stroke Program, Hunter Medical Research Institute, NSW, Australia; Hunter Stroke Service, Hunter New England Local Health District, Newcastle, NSW, Australia.
J Stroke Cerebrovasc Dis. 2023 Aug;32(8):107190. doi: 10.1016/j.jstrokecerebrovasdis.2023.107190. Epub 2023 May 20.
Is it feasible and safe to conduct an exercise dose-finding study in people with stroke? Is it possible to determine a minimal dose of exercise required to see clinically meaningful improvements in cardiorespiratory fitness?
Dose-escalation study. Twenty people with stroke (n=5 per cohort) who were able to walk independently participated in home-based, telehealth-supervised aerobic exercise sessions 3 d/week at moderate-vigorous intensity for 8 weeks. Dose parameters of frequency (3 d/week), intensity (55-85% of heart rate peak) and program length (8 weeks) were kept constant. The duration of exercise sessions was increased by 5 min per session from Dose 1 (10 min/session) to Dose 4 (25 min/session). Doses were escalated if safe and tolerable (< 33% of a cohort reaching a dose-limiting threshold). Doses were efficacious if ≥ 67% of a cohort increased peak oxygen consumption ≥ 2mL/kg/min.
Target exercise doses were well adhered to, and the intervention was safe (480 exercise sessions delivered; one fall resulting in minor laceration) and tolerable (no participants met the dose-limiting threshold). None of the exercise doses met our criterion for efficacy.
It is possible to conduct a dose-escalation trial for people with stroke. The small cohort sizes may have limited the ability to determine an efficacious minimum dose of exercise. Providing supervised exercise session at these prescribed doses via telehealth was safe.
The study was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000460303).
在脑卒中患者中进行运动剂量探索研究是否可行且安全?是否有可能确定最小运动剂量,以观察到心肺适能的临床显著改善?
递增剂量研究。20 名能够独立行走的脑卒中患者(n=5 人/队列)参与了基于家庭的、远程医疗监督的有氧运动,每周 3 天,中等至剧烈强度,持续 8 周。频率(每周 3 天)、强度(心率峰值的 55-85%)和方案长度(8 周)等剂量参数保持不变。每次运动的持续时间从剂量 1(10 分钟/次)增加 5 分钟,直至剂量 4(25 分钟/次)。如果安全且可耐受(<33%的队列达到剂量限制阈值),则增加剂量。如果≥67%的队列的峰值耗氧量增加≥2mL/kg/min,则认为剂量有效。
目标运动剂量得到了很好的遵守,干预是安全的(共进行了 480 次运动;一次跌倒导致轻微撕裂伤)且可耐受(没有参与者达到剂量限制阈值)。没有任何运动剂量符合我们的有效剂量标准。
在脑卒中患者中进行递增剂量试验是可行的。较小的队列规模可能限制了确定有效最小运动剂量的能力。通过远程医疗提供规定剂量的监督运动是安全的。
该研究在澳大利亚和新西兰临床试验注册中心(ACTRN12617000460303)进行了注册。