Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized c
- PDF / 820,147 Bytes
- 9 Pages / 595.276 x 790.866 pts Page_size
- 29 Downloads / 167 Views
STUDY PROTOCOL
Open Access
Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized clinical trial Esther Fernandes Tinoco Volpe1,2, Vanessa R. Resqueti1,2, Ana Aline Marcelino da Silva1,2, Lucien Peroni Gualdi1,3 and Guilherme A. F. Fregonezi1,2*
Abstract Background: Chronic venous insufficiency (CVI) causes pathophysiological changes in the lower-limb muscles, particularly the calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decrease quality of life (QOL). Although several studies have shown the benefits of exercise (strengthening the calf muscles to improve calf-muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf-muscle endurance as well as QOL in patients with CVI. Methods/design: This is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with a CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or a control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf-muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. The first statistical comparison will be performed after 8 weeks’ intervention. Discussion: Patients with CVI may have an impaired calf-muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program should provide much needed information on the management of CVI to promote health and independence. (Continued on next page)
* Correspondence: [email protected] 1 PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte CEP: 59078-900, Brazil 2 Laboratório de Inovação Tecnológica em Reabilitação, Departamento de Fisioterapia, Universidade Federal do Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author
Data Loading...
