Rehabilitation Sciences Program, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
Marinha do Brasil, Belo Horizonte, Brazil.
BMJ Open. 2024 Mar 29;14(3):e080071. doi: 10.1136/bmjopen-2023-080071.
Peripheral arterial disease (PAD) is increasingly prevalent, and supervised physical exercise programmes are recommended as the first-line treatment. However, these programmes are underused. Alternative delivery models may be able to expand treatment coverage. The objective of this study was to compare a home-based exercise programme (HBEP) and a centre-based exercise (CBE) in terms of their effects on functional capacity, peripheral muscle oxygenation and quality of life in individuals with PAD.
This single-blind, parallel randomised clinical trial will consist of two groups: HBEP and CBE. A qualitative analysis will be carried out to investigate acceptability and satisfaction. The primary outcome will be functional capacity, assessed by the incremental shuttle walk test. Secondary outcomes will include functional capacity, assessed by a treadmill walking test; peripheral muscle oxygenation and quality of life; and self-reported functional impairment, risk factors, morbidity, level of physical activity, adherence, acceptability and satisfaction. The intervention protocols will consist of 12 weeks of intermittent walking until claudication symptoms, three times a week. Participants randomly assigned to the CBE group will participate in supervised face-to-face sessions. The HBEP group will perform exercises at home with remote supervision, monitored by a pedometer and heart rate monitor, and subjective perception of effort during each session will be recorded by participants in a training diary; follow-up will be conducted by telephone calls. Statistical analyses will follow the intention-to-treat principle. Participants allocated to the HBEP group will be interviewed about their experience of remote treatment using a qualitative approach.
Ethics approval was obtained from the Ethics Committee of the Universidade Federal de Minas Gerais. The results will be disseminated in a peer-reviewed journal and presented at international congresses. This research has the potential to improve the care of people with PAD because if home-based rehabilitation demonstrates effectiveness, it could be considered an alternative or support resource to the usual centre-based treatment models, expanding access, coverage and participation in vascular physiotherapy TRIAL REGISTRATION: https://ensaiosclinicos.gov.br/rg/RBR-97vy9n7 on 14 April 2022.
外周动脉疾病（PAD）的发病率越来越高，建议采用监督下的体育锻炼方案作为一线治疗方法。然而，这些方案的应用不足。替代的交付模式可能能够扩大治疗范围。本研究的目的是比较家庭为基础的运动方案（HBEP）和以中心为基础的运动（CBE）在功能能力、外周肌肉氧合和 PAD 患者生活质量方面的效果。
这是一项单盲、平行随机临床试验，将包括两组：HBEP 和 CBE。将进行定性分析以调查可接受性和满意度。主要结局将是功能能力，通过递增穿梭步行测试来评估。次要结局将包括功能能力，通过跑步机步行测试评估；外周肌肉氧合和生活质量；以及自我报告的功能障碍、风险因素、发病率、身体活动水平、依从性、可接受性和满意度。干预方案将包括 12 周间歇性行走，直到跛行症状，每周三次。随机分配到 CBE 组的参与者将参加面对面的监督课程。HBEP 组将在家中进行远程监督的运动，通过计步器和心率监测器进行监测，并由参与者在每次训练日记中记录主观感知的努力程度；通过电话进行随访。统计分析将遵循意向治疗原则。将对 HBEP 组的参与者进行采访，了解他们对远程治疗的体验，采用定性方法。
伦理批准已获得米纳斯吉拉斯联邦大学伦理委员会的批准。结果将在同行评议的期刊上发表，并在国际大会上展示。这项研究有可能改善 PAD 患者的护理，因为如果家庭为基础的康复证明有效，它可以被视为常规以中心为基础的治疗模式的替代或支持资源，扩大血管物理治疗的获得、覆盖范围和参与。试验注册：https://ensaiosclinicos.gov.br/rg/RBR-97vy9n7 于 2022 年 4 月 14 日。
