Effect of the elastic tape on COPD patients submitted to pulmonary rehabilitation

• Grant number: 22/09628-1
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Effective date (Start): September 01, 2022
• Effective date (End): August 31, 2025
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Celso Ricardo Fernandes de Carvalho
• Grantee: Juliana de Melo Batista dos Santos
• 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

Thoracoabdominal asynchrony reduces ventilatory efficiency during exercise. However, a recent study developed by the group reports that the use of Elastic Tape (ET) decreases thoracoabdominal asynchrony. Therefore, this study hypothesizes that the use of ET during pulmonary rehabilitation improves performance during exercise, consequently bringing better physical conditioning and thus increasing exercise capacity, quality of life, and increased physical activity level. Objectives: I) to evaluate the effect of the ET in increasing the physical capacity of participants with severe and very severe COPD undergoing pulmonary rehabilitation; II) to evaluate the effects of the ET on the levels of anxiety and depression as well as on the quality of life of participants with severe and very severe COPD undergoing pulmonary rehabilitation; III) to evaluate the diaphragmatic mobility of participants with severe and very severe COPD comparing with the use of ET and without the use of ET. Methods: This is a randomized, controlled clinical trial. Participants with COPD will be screened and recruited at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo (HCFMUSP). The sample will be composed of 50 adult patients with a diagnosis of moderate to very severe COPD according to the GOLD 2020, clinical stability (i.e. no exacerbations for at least 30 days), male, non-obese (BMI d29 .9 kg/m2), without musculoskeletal limitation, not included in another research protocol and not included in a pulmonary rehabilitation program in the last 6 months. Participants will be evaluated on 2 non-consecutive days (7 days apart). At visit 1, clinical and anthropometric data will be obtained, questionnaires will be answered to assess clinical control (CAT), health-related quality of life (CRQ), will perform a complete pulmonary function test (PFP), and will receive the triaxial accelerometer (Actigraph, model GT3X) to assess Physical Activity Level (PAL) and will be instructed to return after 7 days. After that, at Visit 2, participants will undergo a maximal effort test, the Incremental Shuttle Walking Test (ISWT), and a diaphragmatic ultrasound (USG) will be performed with ET and without ET. After the evaluations, the participants will be randomized. After inclusion, participants will start a Pulmonary Rehabilitation (PR) program for 8 weeks, twice a week, participants in the ET group will have the tape placed at the beginning of each session and removed at the end of it. There will be 30 minutes of aerobic resistance exercises on a treadmill and 30 minutes of muscle strengthening exercises for upper and lower limbs. At the end of the 8 weeks of PR, participants will again undergo the same tests performed in Visits 1 and 2. The Kolmogorov-Smirnov test will assess data normality and the Levene test will assess homoscedasticity. Data will be presented as mean and standard deviation for data with normal distribution and as median and interquartile range [25-75%] for non-normal distribution. For inter- and intra-group comparisons, a two-way Analysis of Variance (ANOVA) with repeated measures and Bonferroni's post hoc test or Kruskal-Wallis test followed by Dunn's posthoc test will be performed. with the normality of the data. Statistical procedures will be performed on an intention-to-treat basis. The significance level will be adjusted to 5% (p<0.05) for all tests and the GraphPad Prisma version 5.0 program will be used for statistical analysis. (AU)