Clinical trial NCT04415957: Elastic Tape Relieves Symptoms and Improves Health-related Quality of Life in COPD (Chronic Obstructive Pulmonary Disease)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
dyspnea
respiratory mechanics
exercise capacity
physical activity
elastic tape
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2020-06-04
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in daily life physical activity (DLPA)
timeFrame: Change from baseline physical activity levels after 14 days of intervention
Secondary outcomes:
measure: Change in dyspnea
timeFrame: Change from baseline dyspnea at 7th and 14th days of intervention
measure: Change in health status
timeFrame: Change in health status after 14 days of intervention
measure: Change in health-related quality of life (HRQoL)
timeFrame: Change in HRQoL after 14 days of intervention
measure: Change in anxiety and depression symptoms
timeFrame: Change from baseline anxiety and depression symptoms after 14 days of intervention
measure: Change in barriers to daily life physical activity (DLPA)
timeFrame: Change in barriers to DLPA after 14 days of intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Clinical Hospital of São Paulo University medical school (HCFMUSP)
Study officials:
affiliation: University of São Paulo General Hospital
name: Celso RF Carvalho, PhD
role: STUDY_DIRECTOR
References:
citation: Pinto TF, Fagundes Xavier R, Lunardi AC, Marques da Silva CCB, Moriya HT, Lima Vitorasso R, Torsani V, Amato MBP, Stelmach R, Salge JM, Carvalho-Pinto RM, Carvalho CRF. Effects of elastic tape on thoracoabdominal mechanics, dyspnea, exercise capacity, and physical activity level in nonobese male subjects with COPD. J Appl Physiol (1985). 2020 Sep 1;129(3):492-499. doi: 10.1152/japplphysiol.00690.2019. Epub 2020 Jul 23.
citation: Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.
citation: Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008 Jan;40(1):181-8. doi: 10.1249/mss.0b013e31815a51b3.
citation: von Leupoldt A, Reijnders T, Schuler M, Wittmann M, Jelusic D, Schultz K. Validity of a Self-administered Questionnaire Version of the Transition Dyspnea Index in Patients with COPD. COPD. 2017 Feb;14(1):66-71. doi: 10.1080/15412555.2016.1246522. Epub 2016 Nov 14.
citation: Mahler DA, O'Donnell DE. Recent advances in dyspnea. Chest. 2015 Jan;147(1):232-241. doi: 10.1378/chest.14-0800.
citation: Dodd JW, Hogg L, Nolan J, Jefford H, Grant A, Lord VM, Falzon C, Garrod R, Lee C, Polkey MI, Jones PW, Man WD, Hopkinson NS. The COPD assessment test (CAT): response to pulmonary rehabilitation. A multicentre, prospective study. Thorax. 2011 May;66(5):425-9. doi: 10.1136/thx.2010.156372. Epub 2011 Mar 12.
citation: Smid DE, Franssen FM, Houben-Wilke S, Vanfleteren LE, Janssen DJ, Wouters EF, Spruit MA. Responsiveness and MCID Estimates for CAT, CCQ, and HADS in Patients With COPD Undergoing Pulmonary Rehabilitation: A Prospective Analysis. J Am Med Dir Assoc. 2017 Jan;18(1):53-58. doi: 10.1016/j.jamda.2016.08.002. Epub 2016 Sep 10.
citation: Williams JE, Singh SJ, Sewell L, Guyatt GH, Morgan MD. Development of a self-reported Chronic Respiratory Questionnaire (CRQ-SR). Thorax. 2001 Dec;56(12):954-9. doi: 10.1136/thorax.56.12.954.
citation: Moreira GL, Pitta F, Ramos D, Nascimento CS, Barzon D, Kovelis D, Colange AL, Brunetto AF, Ramos EM. Portuguese-language version of the Chronic Respiratory Questionnaire: a validity and reproducibility study. J Bras Pneumol. 2009 Aug;35(8):737-44. doi: 10.1590/s1806-37132009000800004.
citation: Cullen K, Talbot D, Gillmor J, McGrath C, O'Donnell R, Baily-Scanlan M, Broderick J. Effect of Baseline Anxiety and Depression Symptoms on Selected Outcomes Following Pulmonary Rehabilitation. J Cardiopulm Rehabil Prev. 2017 Jul;37(4):279-282. doi: 10.1097/HCR.0000000000000258.
citation: Amorim PB, Stelmach R, Carvalho CR, Fernandes FL, Carvalho-Pinto RM, Cukier A. Barriers associated with reduced physical activity in COPD patients. J Bras Pneumol. 2014 Oct;40(5):504-12. doi: 10.1590/s1806-37132014000500006.