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NCT04415957 | Completed | Chronic Obstructive Pulmonary Disease


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

University of Sao Paulo General Hospital

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).

Condition or disease

Chronic Obstructive Pulmonary Disease

Intervention/treatment

Elastic Tape

Phase

Not Applicable

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.

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking: Double
Masking Description: 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.
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022
Arm Intervention/treatment

Experimental: Elastic Tape Group (ETG)

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.

No Intervention: Control Group (CG)

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.

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
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.

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

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

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Locations


Not yet recruiting

Brazil,

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, Brazil, 05360-160

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