Elastic Tape Reduces Dyspnea and Improves Health Status, and Health-related Quality of Life in Non-obese COPD Males: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in daily life physical activity (DLPA)
研究概览
简要总结
- 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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The randomization sequence was computer-generated and implemented by an investigator not involved in recruitment, assessment, or treatment. Concealment allocation was assured by placing the randomization in opaque envelopes sequentially numbered. An envelope for every participant was opened in sequential order after baseline assessments. The participants and physical therapists who performed the intervention could not be blinded due to the nature of the intervention. However, all the outcomes and statistical assessors were blinded to group allocation and previous test results.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Mild to severe COPD diagnosis (according to the GOLD 2022 classification);
- •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.
排除标准
- •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.
结局指标
主要结局
Change in daily life physical activity (DLPA)
时间窗: Change from baseline physical activity levels after 14 days of intervention
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.
次要结局
- Change in health-related quality of life (HRQoL)(Change in HRQoL after 14 days of intervention)
- Change in anxiety and depression symptoms(Change from baseline anxiety and depression symptoms after 14 days of intervention)
- Change in barriers to daily life physical activity (DLPA)(Change in barriers to DLPA after 14 days of intervention)
- Change in dyspnea(Change from baseline dyspnea at 7th and 14th days of intervention)
- Change in health status(Change in health status after 14 days of intervention)