Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial

• Published in: BMJ open Vol. 14; no. 3; p. e080071
• Main Authors: Nascimento, Isabella de Oliveira, Geisel, Patrícia Paulino, de Faria, Valéria Cristina, Ferreira, Ana Paula, Passos, Bruno Rezende, Prado, Déborah, Parreira, Veronica Franco, Gomes Pereira, Danielle
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 29.03.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Cardiovascular disease; Chronic Disease; Clinical trials; Exercise; Exercise Therapy - methods; Heart failure; Humans; Ischemia; Low income groups; Muscles; Peripheral Arterial Disease - therapy; Physical fitness; Physical therapy; Physical Therapy Modalities; Public health; Quality of Life; Randomized Controlled Trials as Topic; Rehabilitation; Rehabilitation Medicine; Single-Blind Method; VASCULAR MEDICINE; Walking; Brazil; Physical Therapy Modalities; VASCULAR MEDICINE; Chronic Disease; REHABILITATION MEDICINE
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2023-080071

IntroductionPeripheral 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.Methods and analysisThis 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 and disseminationEthics 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 physiotherapyTrial registrationhttps://ensaiosclinicos.gov.br/rg/RBR-97vy9n7 on 14 April 2022.