Question

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?

Methods

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.

Results

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.

Conclusions

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.

Registration

The study was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000460303).

中文翻译：

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多少才够？对中风患者进行运动训练剂量递增研究的可行性

问题

对中风患者进行运动剂量探索研究是否可行且安全？是否有可能确定在心肺健康方面看到具有临床意义的改善所需的最小运动量？

方法

剂量递增研究。20 名能够独立行走的中风患者（每组 n = 5）参加了以家庭为基础、远程医疗监督的有氧运动课程，每周 3 天，强度适中，持续 8 周。频率（3 天/周）、强度（心率峰值的 55-85%）和程序长度（8 周）的剂量参数保持不变。从第 1 次（10 分钟/次）到第 4 次（25 分钟/次），每次锻炼的持续时间增加 5 分钟。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% 的队列增加峰值耗氧量 ≥ 2mL/kg/min，则剂量是有效的。

结果

目标运动剂量得到很好的遵守，干预是安全的（进行了 480 次运动；一次跌倒导致轻微撕裂伤）并且可以忍受（没有参与者达到剂量限制阈值）。没有一种运动剂量符合我们的疗效标准。

结论

可以对中风患者进行剂量递增试验。小队列规模可能限制了确定有效的最小运动量的能力。通过远程医疗提供这些规定剂量的监督锻炼是安全的。

登记

该研究已在澳大利亚新西兰临床试验注册中心 (ACTRN12617000460303) 注册。