Effects of inclined treadmill training on functional and cardiovascular parameters of stroke patients: Study protocol for a randomized controlled trial

Abstract

Background: Treadmill training has been widely used for gait recovery after stroke. Gait re-establishment is one of the main objectives of rehabilitation programs after stroke, aiming to acquire more functional patterns and increase walking speed, along with improvement in cardiovascular function. The aim of this study is to evaluate the effects of a treadmill gait training protocol on functional and cardiovascular variables in patients with chronic stroke. Methods: A single-blind randomized clinical trial will be conducted. The sample will consist of 36 patients, who will be allocated in three groups: control group (n = 12), experimental group 1 (n = 12), and experimental group 2 (n = 12). The intervention will occur for 6 consecutive weeks, three times a week, 30 min each session, in all groups. The control group will perform a treadmill gait training without inclination, experimental group 1 will perform a treadmill gait training with anterior inclination of 5%, and experimental group 2 will perform a treadmill gait training with anterior inclination of 10%. All participants will be assessed for sample characterization measures, gait speed, functional capacity, systemic arterial blood pressure, heart rate, peripheral oxygen saturation, exercise capacity, neuromuscular torque, and quality of life. Evaluations of outcome measures will occur at the end of the interventions (post-training) and after 1 month and 1 year after the end of the interventions (short- and long-term follow-up). Statistical analysis will be performed descriptively and inferentially. Alpha equals 5% will be considered for inferential analysis. Mixed analysis of variance with repeated measures will be used to compare outcome measures between groups and between baseline, post-training, and follow-up. Normality test (Shapiro-Wilk) and subsequently t test (or Mann-Whitney) will be used to compare groups during the same training session. Discussion: It is believed that treadmill training, especially treadmill training with anterior inclination, may result in improved exercise capacity in patients with stroke, reduced blood pressure and heart rate values, and an improvement in functional parameters with increased gait speed, functional capacity, quadriceps muscle torque, and quality of life. Trial registration: Registration in Brazilian Registry of Clinical Trials (ReBEC) identifier RBR-5ffbxz, date of registration October 25 2017.