Family Medicine Riu Nord-Riu Sud, Institut Català de la Salut, Santa Coloma de Gramenet, Spain
USR Metropolitana Nord, IDIAP Jordi Gol, Barcelona, Spain.
BMJ Open. 2022 Apr 27;12(4):e054352. doi: 10.1136/bmjopen-2021-054352.
Peripheral arterial disease (PAD) is a marker of cardiovascular morbidity, causing disability, loss of mobility and poor quality of life, manifesting clinically in the form of intermittent claudication (IC). Physical exercise increases the distance walked and improves quality of life. The aim of our study will be increased walking distance prolonging the time of onset of pain in patients with symptomatic PAD (IC).
This study will be performed in Mataró Hospital's vascular surgery service and School of Health Sciences, TecnoCampus. This population comes from 15 primary healthcare centres ofNorth Barcelona, Spain (450 000 inhabitants).This study will be a four-group parallel, longitudinal, randomised controlled trial, blind to analysis.The main primary outcome of this study will be the improvement in pain-free walking distance. Others primary objectives are and improvement in functional status, quality of life and Ankle-Brachial Index (ABI). Secondary outcomes will be the analysis of cardiorespiratory fitness, evaluation of muscle fitness, determine the maintenance of primary objectives at 6 and 12 months.We will be included 124 patients (31 per group). The changes of the outcome (Barthel, SF-12, VascQOL-6, ABI) of the three intervention groups vs the control group at 3, 6 and 12 months will be compared, both continuously (linear regression) and categorically (logistic regression). A person who has not performed at least 75% of the training will be considered to have not completed the intervention.
The study will be conducted according to the Declaration of Helsinki . It was approved by the Ethics Committee of the Research Institute Primary Health IDIAP Jordi Gol (20/035 P),Barcelona 6 October 2020. Informed consent will be obtained from all patients before the start of the study. We will disseminate results through academic papers and conference presentations.
NCT04578990.
外周动脉疾病（PAD）是心血管发病率的标志物，导致残疾、丧失活动能力和生活质量下降，临床上表现为间歇性跛行（IC）。体育锻炼可以增加步行距离，提高生活质量。我们研究的目的是增加有症状的 PAD（IC）患者的无痛步行距离，延长疼痛发作时间。
这项研究将在 Mataró 医院的血管外科服务和健康科学学院 TecnoCampus 进行。该人群来自西班牙巴塞罗那北部的 15 个初级保健中心（450000 居民）。这将是一项四组平行、纵向、随机对照试验，分析结果为盲法。本研究的主要主要结局将是改善无痛步行距离。其他主要目标是改善功能状态、生活质量和踝肱指数（ABI）。次要结局将是分析心肺功能适应性，评估肌肉适应性，确定 6 个月和 12 个月时主要目标的维持情况。我们将纳入 124 名患者（每组 31 名）。将比较三组干预组与对照组在 3、6 和 12 个月时的结果（Barthel、SF-12、VascQOL-6、ABI）的变化，包括连续（线性回归）和分类（逻辑回归）。如果一个人没有完成至少 75%的训练，将被认为没有完成干预。
该研究将按照《赫尔辛基宣言》进行。它于 2020 年 10 月 6 日在巴塞罗那由初级卫生研究所 IDIAP Jordi Gol 研究伦理委员会（20/035P）批准。在开始研究之前，将获得所有患者的知情同意。我们将通过学术论文和会议报告传播研究结果。
NCT04578990。
