Elastic Tape Relieves Symptoms and Improves Health-related Quality of Life in COPD (Chronic Obstructive Pulmonary Disease)

Background: The elastic tape (ET) is a novel intervention that has been shown to improve exercise capacity acutely in laboratory tests; however, its effect on a patient's daily life remains poorly known. Research Question: Does the ET influence on daily life physical activity (DLPA), dyspnea, health status, and health-related quality of life (HRQoL) in individuals with COPD? Study Design and Methods: Fifty non-obese males with moderate to very severe COPD were randomly allocated to intervention (ETG) or control groups (CG). Eligible individuals were invited to participate after a regular medical visit and randomized into two groups. The protocol lasted 21 days, including seven days of initial assessments and 14 days of intervention. The ETG received the ET positioned in the chest wall and abdomen for 14 days while CG received the usual care. Dyspnea symptoms (Transition dyspnea index, TDI; and modified Medical Research Council, mMRC) were evaluated at baseline (day 0 of protocol, visit 1), day 7 of protocol (visit 2) and day 14 of protocol (visit 3). DLPA (accelerometry), health status (COPD assessment test, CAT), and HRQoL (CRQ) were evaluated before and after the intervention. All outcomes were reassessed after seven days (day 14 of protocol, visit 3). CG received instructions about the importance of becoming physical activity. In addition, CG also had 3 visits and performed the same assessments as the ETG. At the end of protocol, the participants of CG were invited to place the ETs. Sample size and data analysis: The sample size was calculated from a pilot study. The primary outcome used was the number of step-counts (2,800±3,500, mean (MD) ± standard deviation (SD)). A sample size of 25 participants per group was obtained to detect between-group differences (α=0.05, 1-β=0.8). Group and time interactions were assessed using a two-way repeated-measures analysis of variance (ANOVA) followed by a post hoc test of Holm-Sidak. Non-parametric data were tested by the corresponding non-parametric tests. Data were analyzed according to the intention-to-treat principle, and missing values were imputed by the expected maximization (EM) technique, using IBM SPSS Statistics for Windows (version 22). Altogether, two participants who lost follow-up had their data imputed, and one patient that exacerbated during the study was reassessed after discharge. Results: No between-group differences were observed at baseline. ET reduced the dyspnea symptoms in all TDI domains (functional, task, and effort) and on the mMRC after 14 days compared with CG, reaching a minimal clinically important difference (≥1.0, MCID). In addition, patients in the ETG improved their CAT score compared to the CG, reaching MCID (≤2). The ETG also improved by reaching MCID in most CRQ domains (total, fatigue, emotional, and mastery) on day 14. No differences were observed in DLPA. Conclusion: ET reduces dyspnea and improves the health status and quality of life in non-obese males with moderate to very severe COPD at mid-term. This novel and low-cost intervention can improve COPD symptoms in patients with COPD.