School of Sport and Health Sciences, University of Central Lancashire, Preston PR1 2HE, UK.
School of Sport and Health Sciences, University of Central Lancashire, Preston, UK.
Ther Adv Cardiovasc Dis. 2022 Jan-Dec;16:17539447221108817. doi: 10.1177/17539447221108817.
Peripheral artery disease affects over 236 million people globally and the classic symptom is intermittent claudication (IC) which is associated with reduction in physical activity. The evidence that supervised exercise programmes (SEPs) improve pain-free and maximal walking distance is irrefutable. However, adherence rates are low with exercise-related pain cited as a contributing factor. National and international guidelines recommend exercising at a moderate to maximal level of claudication pain to improve walking ability; however, exercising pain-free or at mild claudication pain has been shown to achieve this outcome. There is limited evidence that compares the relative effects of exercise prescribed at different levels of claudication pain.
The objective of this study is to directly compare the effects of exercise prescribed at three different levels of claudication pain on walking performance.
This study will be a single-centre randomised controlled trial.
Based on an power calculation, 51 patients with IC will be allocated to 24 weeks of twice-weekly pain-free (PF), moderate pain (MOD-P) or maximal pain (MAX-P) exercise. The PF group will cease exercise at the onset of claudication (1 on the 0-4 IC rating scale), the MOD-P group will stop once moderate pain is reached (2 on the rating scale) and the MAX-P group will stop once maximal pain is reached (4 on the rating scale).
Outcome measures will be assessed at baseline, 12 and 24 weeks adopting an analysis of covariance (ANCOVA) to compare MWD across three time points. The primary outcome for the trial will be change in maximal treadmill walking distance at 12 and 24 weeks.
Trial registration number: NCT04370327.
全球有超过 2.36 亿人患有外周动脉疾病，其典型症状是间歇性跛行（IC），这与体力活动减少有关。有确凿证据表明，监督下的运动方案（SEPs）可改善无疼痛和最大步行距离。然而，运动相关疼痛被认为是导致依从性低的一个因素。国家和国际指南建议在跛行疼痛的中度至最大程度下进行运动，以提高步行能力；然而，无疼痛或轻度跛行疼痛下进行运动已被证明可以达到这一结果。比较不同跛行疼痛水平下规定的运动的相对效果的证据有限。
本研究的目的是直接比较在三种不同跛行疼痛水平下规定的运动对步行表现的影响。
这将是一项单中心随机对照试验。
根据功效计算，51 名 IC 患者将被分配到 24 周的每周两次无疼痛（PF）、中度疼痛（MOD-P）或最大疼痛（MAX-P）运动。PF 组将在出现跛行时停止运动（IC 评级量表上的 1），MOD-P 组将在达到中度疼痛时停止（评级量表上的 2），MAX-P 组将在达到最大疼痛时停止（评级量表上的 4）。
将在基线、12 和 24 周时采用协方差分析（ANCOVA）评估结果测量值，以比较三个时间点的最大跑步机步行距离。试验的主要结局是 12 和 24 周时最大跑步机步行距离的变化。
试验注册号：NCT04370327。
