Effect of the elastic tape on exercise capacity and daily physical activity level in patients with COPD severe and very severe: crossover and randomized clinical trial

• Grant number: 23/00129-5
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: March 01, 2023
• End date: February 29, 2024
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Celso Ricardo Fernandes de Carvalho
• Grantee: Rodolfo Santos Deda
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated research grant: 18/17788-3 - Pulmonary rehabilitation: effect of new patient-centered methodologies and technologies in patients with chronic pulmonary diseases, AP.TEM

Abstract

Introduction: Chronic Obstructive Pulmonary Disease (COPD) is characterized by the presence of chronic and progressive obstruction of the expiratory flow, associated with an atypical inflammatory response of the airways and lung parenchyma to toxic particles and gases. One of its main symptoms is dyspnea, associated with minor physical exertion, such as performing activities of daily living, walking, and/or climbing stairs. In more severe situations, dyspnea can occur with minimal daily effort. In addition to dyspnea, severe and very severe COPD patients have thoracoabdominal asynchrony (TAA), which reduces ventilatory efficiency and exercise capacity. Based on this information, it was hypothesized that the use of a device that could reduce this asynchrony and symptoms of dyspnea would be beneficial for these patients. Therefore, we propose the placement of an elastic tape (ET) in the region of the upper chest, lower chest, and abdomen with the aim of assisting in respiratory mechanics and, allowing an increase in exercise capacity and the level of daily physical activity in patients with COPD. Objective: To evaluate the effect of the elastic tapes on exercise capacity and the level of daily physical activity in patients with severe and very severe COPD. Methods: This randomized crossover study will include 20 non-obese men with severe and very severe COPD. The ET will be placed on the chest wall and abdomen. After randomization, patients will be allocated into 2 groups with or without the ET in the first and second visits. On visit 1, patients allocated to the ET group will receive a triaxial accelerometer and the ET will be applied to be used for 7 consecutive days (between visits 1 and 2) in order to assess the level of physical activity. On visit 2 the ET will be changed and patients will perform a cardiopulmonary exercise test (CPET, 10W/min). Following CPET, ET will be removed and patients instructed to return after 7 and 14 days (visits 3 and 4, respectively). During visits 3 and 4, patients will repeat the same assessments without the ET. Patients randomized to the without tape group will do the reverse order, starting with assessments 1 and 2 without the tape and then performing assessments 3 and 4 with the tape. Statistical analysis: GraphPad Prism software, version 5.0 will be used. Data normality will be evaluated by the Shapiro-Wilk test. Comparisons of exercise capacity and physical activity level data will be evaluated using the Wilcoxon test or paired t-test, according to data normality. The significance level will be set at <0.05.