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

Study Overview
=================
Brief Summary
-----------------
The goal of this randomized controlled trial is to investigate the effects of elastic tape in individuals with mild to very severe COPD. The main questions it aims to answer are: Does the ET influence on daily life physical activity (DLPA), dyspnea, health status, health-related quality of life (HRQoL), and anxiety and depression symptoms in individuals with COPD? Does the ET modify the perceived barriers to DLPA in individuals with COPD? The protocol lasted 21 days, including seven days of initial assessments and 14 days of intervention. Before baseline assessments, participants were randomly allocated into intervention (Elastic Tape Group, ETG, n=25) or control groups (CG, n=25). The ETG received ETs on the chest wall and abdomen for two consecutive weeks while the CG received instructions about the importance of becoming physical activity. The assessments were performed before and after 14 days of intervention. The ET placement was previously described by Pinto et al. (2020).

Detailed Description
-----------------
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.

Official Title
-----------------
Elastic Tape Reduces Dyspnea and Improves Health Status, and Health-related Quality of Life in Non-obese COPD Males: a Randomized Controlled Trial

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Elastic Tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to severe COPD diagnosis (according to the GOLD 2022 classification); Males; Non-obese (BMI≤29.9kg/m2); Former smokers; Clinically stable (i.e.,without exacerbations for at least 30 days); In medical follow-up at a University tertiary hospital specialized for COPD assistance Consent to participate voluntarily in the study and signed the Patients' consent form. Exclusion Criteria: Asthma-COPD overlap; Continuous use of oxygen therapy; Postoperative thoracic surgery; Open wounds or skin diseases on the chest or abdomen; Allergic skin reactions to the use of adhesive bandages, plasters, or other adhesive materials; Cardiovascular or musculoskeletal disease that compromise any assessments; Undergoing pulmonary rehabilitation(PR); Participating in other research studies; Unability to understand our questionnaire.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elastic Tape Group (ETG)<br>The ET placement was previously described by Pinto et al. (2020). Briefly, the subject's trunk was passively extended for ET placement. The ET was placed considering the origins and insertions of the following muscles: rectus abdominis, internal oblique, and internal intercostal. ET has shown six days of durability on average, so the participants were asked to return to change the ET after seven days. | Other: Elastic Tape<br>* The subject's trunk was passively extended for ET placement. The ET was placed on the chest wall and abdomen, considering the origins and insertions of the following muscles: rectus abdominis, internal oblique, and internal intercostal. The intervention lasted 14 days, therefore, the participants remained with the tapes for two consecutive weeks. Due to the adhesive durability of ETs (6 weeks on average), the participants were asked to return to change the ET after seven days.<br>|
| No Intervention: Control Group (CG)<br>CG received instructions about the importance of becoming physical activity. Furthermore, the participants included in CG were invited to place the ETs at the end of the protocol. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily life physical activity (DLPA) | Participants were instructed to wear the device for the waking hours of seven consecutive days, removing it only during swimming activities. A valid DLPA day was considered when the device had at least eight hours of data collection. In addition, every individual had at least five days per week. DLPA and sedentary time intensity were classified by the total activity counts accumulated in 60-s epoch length with the normal signal processing filter and sampling frequency of 60Hz. The Troiano et al. (2008) algorithm cut points were applied to set DLPA. Data were presented as the average number of steps per day (steps/day), time spent in moderate to vigorous physical activities (MVPA, minutes/day), and sedentary time, expressed as the percentage of waking hours. | Change from baseline physical activity levels after 14 days of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dyspnea | Two different dyspnea scales were used modified Medical Research Council (mMRC) and Baseline and Transitional dyspnea index (BDI/TDI). The mMRC is a unidirectional 0-4-point scale whose questions closely match daily activities that provoke dyspnea. It has also been used in clinical practice to categorize COPD symptomatic burden and provide useful information about COPD-induced disability. The BDI/TDI questionnaire is a multidimensional assessment of dyspnea. The BDI/TDI has been widely validated in COPD and remains the most frequently used questionnaire in clinical research, particularly for therapeutic trials. BDI/TDI evaluates dyspnea in three domains: functional impairment, the magnitude of the task, and the magnitude of effort. The change of 1.0 point is considered a minimal clinically important difference (MCID). The higher the score in TDI, the greater the improvement in dyspnea. | Change from baseline dyspnea at 7th and 14th days of intervention | 
| Change in health status | Health status was assessed using the COPD Assessment Test (CAT). CAT aims to measure the impact of COPD on a patient's health status. The items include physical symptoms (cough, phlegm, chest tightness, breathlessness), activity limitation, energy besides confidence in leaving home, and sleep quality. CAT has a total maximum score of 40 points (maximum impairment). Scores from 0 to 10, 11 to 20, 21 to 30, and 31 to 40 represent mild, moderate, severe, or very severe clinical impact, respectively. A change of -2.54 points is considered a MCID. | Change in health status after 14 days of intervention | 
| Change in health-related quality of life (HRQoL) | HRQoL was assessed using the Chronic Respiratory Questionnaire (CRQ). The CRQ is a validated questionnaire developed to evaluate the effects of treatments on quality of life in clinical trials and has been validated in Brazilian-Portuguese. The CRQ comprises four domains: dyspnea, fatigue, emotional function, and mastery. An MCID has been determined as 0.5 for each mean domain score, and higher scores indicate improvement in HRQoL. | Change in HRQoL after 14 days of intervention | 
| Change in anxiety and depression symptoms | The anxiety and depression symptoms were assessed by the Hospital Anxiety and Depression scale (HADs), which consists of 14 items divided into two subscales (seven questions for anxiety and seven for depression). Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale. A score greater than 9 in each subscale suggests a probable clinical diagnosis of either anxiety and/or depression. | Change from baseline anxiety and depression symptoms after 14 days of intervention | 
| Change in barriers to daily life physical activity (DLPA) | The barriers to physical activity were evaluated by a questionnaire developed by Amorim et al.(2014) for patients with COPD. The questionnaire consists of 21 items rated from 0 to 3 (0= never; 3= always) divided into seven domains: lack of time, social influence, lack of energy, lack of will, fear of injury, lack of skill, and lack of structure. The score per domain ranges from 0 to 9, with a maximum of 63 points. Higher scores indicate a greater barrier, and scores greater than five are considered significant. | Change in barriers to DLPA after 14 days of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, dyspnea, respiratory mechanics, exercise capacity, physical activity, elastic tape