<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04415957</url>
  </required_header>
  <id_info>
    <org_study_id>ETPADCOPD</org_study_id>
    <nct_id>NCT04415957</nct_id>
  </id_info>
  <brief_title>Elastic Tape Relieves Symptoms and Improves Health-related Quality of Life in COPD (Chronic Obstructive Pulmonary Disease)</brief_title>
  <acronym>COPD</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  The goal of this randomized controlled trial is to investigate the effects of elastic&#xD;
           tape in individuals with mild to very severe COPD.&#xD;
&#xD;
        -  The main questions it aims to answer are:&#xD;
&#xD;
      Does the ET influence on daily life physical activity (DLPA), dyspnea, health status,&#xD;
      health-related quality of life (HRQoL), and anxiety and depression symptoms in individuals&#xD;
      with COPD?&#xD;
&#xD;
      Does the ET modify the perceived barriers to DLPA in individuals with COPD?&#xD;
&#xD;
        -  The protocol lasted 21 days, including seven days of initial assessments and 14 days of&#xD;
           intervention. Before baseline assessments, participants were randomly allocated into&#xD;
           intervention (Elastic Tape Group, ETG, n=25) or control groups (CG, n=25). The ETG&#xD;
           received ETs on the chest wall and abdomen for two consecutive weeks while the CG&#xD;
           received instructions about the importance of becoming physical activity. The&#xD;
           assessments were performed before and after 14 days of intervention.&#xD;
&#xD;
        -  The ET placement was previously described by Pinto et al. (2020).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The elastic tape (ET) is a novel intervention that has been shown to improve&#xD;
      exercise capacity acutely in laboratory tests; however, its effect on a patient's daily life&#xD;
      remains poorly known.&#xD;
&#xD;
      Research Question: Does the ET influence on daily life physical activity (DLPA), dyspnea,&#xD;
      health status, and health-related quality of life (HRQoL) in individuals with COPD?&#xD;
&#xD;
      Study Design and Methods: Fifty non-obese males with moderate to very severe COPD were&#xD;
      randomly allocated to intervention (ETG) or control groups (CG). Eligible individuals were&#xD;
      invited to participate after a regular medical visit and randomized into two groups. The&#xD;
      protocol lasted 21 days, including seven days of initial assessments and 14 days of&#xD;
      intervention. The ETG received the ET positioned in the chest wall and abdomen for 14 days&#xD;
      while CG received the usual care. Dyspnea symptoms (Transition dyspnea index, TDI; and&#xD;
      modified Medical Research Council, mMRC) were evaluated at baseline (day 0 of protocol, visit&#xD;
      1), day 7 of protocol (visit 2) and day 14 of protocol (visit 3). DLPA (accelerometry),&#xD;
      health status (COPD assessment test, CAT), and HRQoL (CRQ) were evaluated before and after&#xD;
      the intervention. All outcomes were reassessed after seven days (day 14 of protocol, visit&#xD;
      3). CG received instructions about the importance of becoming physical activity. In addition,&#xD;
      CG also had 3 visits and performed the same assessments as the ETG. At the end of protocol,&#xD;
      the participants of CG were invited to place the ETs.&#xD;
&#xD;
      Sample size and data analysis: The sample size was calculated from a pilot study. The primary&#xD;
      outcome used was the number of step-counts (2,800±3,500, mean (MD) ± standard deviation&#xD;
      (SD)). A sample size of 25 participants per group was obtained to detect between-group&#xD;
      differences (α=0.05, 1-β=0.8). Group and time interactions were assessed using a two-way&#xD;
      repeated-measures analysis of variance (ANOVA) followed by a post hoc test of Holm-Sidak.&#xD;
      Non-parametric data were tested by the corresponding non-parametric tests. Data were analyzed&#xD;
      according to the intention-to-treat principle, and missing values were imputed by the&#xD;
      expected maximization (EM) technique, using IBM SPSS Statistics for Windows (version 22).&#xD;
      Altogether, two participants who lost follow-up had their data imputed, and one patient that&#xD;
      exacerbated during the study was reassessed after discharge.&#xD;
&#xD;
      Results: No between-group differences were observed at baseline. ET reduced the dyspnea&#xD;
      symptoms in all TDI domains (functional, task, and effort) and on the mMRC after 14 days&#xD;
      compared with CG, reaching a minimal clinically important difference (≥1.0, MCID). In&#xD;
      addition, patients in the ETG improved their CAT score compared to the CG, reaching MCID&#xD;
      (≤2). The ETG also improved by reaching MCID in most CRQ domains (total, fatigue, emotional,&#xD;
      and mastery) on day 14. No differences were observed in DLPA.&#xD;
&#xD;
      Conclusion: ET reduces dyspnea and improves the health status and quality of life in&#xD;
      non-obese males with moderate to very severe COPD at mid-term. This novel and low-cost&#xD;
      intervention can improve COPD symptoms in patients with COPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in daily life physical activity (DLPA)</measure>
    <time_frame>Change from baseline physical activity levels after 14 days of intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in dyspnea</measure>
    <time_frame>Change from baseline dyspnea at 7th and 14th days of intervention</time_frame>
    <description>Two different dyspnea scales were used modified Medical Research Council (mMRC) and Baseline and Transitional dyspnea index (BDI/TDI).&#xD;
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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health status</measure>
    <time_frame>Change in health status after 14 days of intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health-related quality of life (HRQoL)</measure>
    <time_frame>Change in HRQoL after 14 days of intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety and depression symptoms</measure>
    <time_frame>Change from baseline anxiety and depression symptoms after 14 days of intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in barriers to daily life physical activity (DLPA)</measure>
    <time_frame>Change in barriers to DLPA after 14 days of intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Elastic Tape Group (ETG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (CG)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Elastic Tape</intervention_name>
    <description>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.</description>
    <arm_group_label>Elastic Tape Group (ETG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild to severe COPD diagnosis (according to the GOLD 2022 classification);&#xD;
&#xD;
          -  Males;&#xD;
&#xD;
          -  Non-obese (BMI≤29.9kg/m2);&#xD;
&#xD;
          -  Former smokers;&#xD;
&#xD;
          -  Clinically stable (i.e.,without exacerbations for at least 30 days);&#xD;
&#xD;
          -  In medical follow-up at a University tertiary hospital specialized for COPD assistance&#xD;
&#xD;
          -  Consent to participate voluntarily in the study and signed the Patients' consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Asthma-COPD overlap;&#xD;
&#xD;
          -  Continuous use of oxygen therapy;&#xD;
&#xD;
          -  Postoperative thoracic surgery;&#xD;
&#xD;
          -  Open wounds or skin diseases on the chest or abdomen;&#xD;
&#xD;
          -  Allergic skin reactions to the use of adhesive bandages, plasters, or other adhesive&#xD;
             materials;&#xD;
&#xD;
          -  Cardiovascular or musculoskeletal disease that compromise any assessments;&#xD;
&#xD;
          -  Undergoing pulmonary rehabilitation(PR);&#xD;
&#xD;
          -  Participating in other research studies;&#xD;
&#xD;
          -  Unability to understand our questionnaire.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celso RF Carvalho, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of São Paulo General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Hospital of São Paulo University medical school (HCFMUSP)</name>
      <address>
        <city>São Paulo</city>
        <zip>05360-160</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <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>
    <PMID>32702276</PMID>
  </reference>
  <reference>
    <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>
    <PMID>20334633</PMID>
  </reference>
  <reference>
    <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>
    <PMID>18091006</PMID>
  </reference>
  <reference>
    <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>
    <PMID>27841688</PMID>
  </reference>
  <reference>
    <citation>Mahler DA, O'Donnell DE. Recent advances in dyspnea. Chest. 2015 Jan;147(1):232-241. doi: 10.1378/chest.14-0800.</citation>
    <PMID>25560861</PMID>
  </reference>
  <reference>
    <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>
    <PMID>21398686</PMID>
  </reference>
  <reference>
    <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>
    <PMID>27624705</PMID>
  </reference>
  <reference>
    <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>
    <PMID>11713359</PMID>
  </reference>
  <reference>
    <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>
    <PMID>19750325</PMID>
  </reference>
  <reference>
    <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>
    <PMID>28640172</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25410838</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>February 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>dyspnea</keyword>
  <keyword>respiratory mechanics</keyword>
  <keyword>exercise capacity</keyword>
  <keyword>physical activity</keyword>
  <keyword>elastic tape</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415957
org study id: ETPADCOPD
nct id: NCT04415957
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
-  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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
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.
measure: Change in daily life physical activity (DLPA)
time frame: Change from baseline physical activity levels after 14 days of intervention
description: 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.
measure: Change in dyspnea
time frame: Change from baseline dyspnea at 7th and 14th days of intervention
description: 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.
measure: Change in health status
time frame: Change in health status after 14 days of intervention
description: 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.
measure: Change in health-related quality of life (HRQoL)
time frame: Change in HRQoL after 14 days of intervention
description: 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.
measure: Change in anxiety and depression symptoms
time frame: Change from baseline anxiety and depression symptoms after 14 days of intervention
description: 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.
measure: Change in barriers to daily life physical activity (DLPA)
time frame: Change in barriers to DLPA after 14 days of intervention
description: 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.
arm group label: Elastic Tape Group (ETG)
arm group type: Experimental
description: 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.
arm group label: Control Group (CG)
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: Elastic Tape
description: 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.
arm group label: Elastic Tape Group (ETG)
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Celso RF Carvalho, PhD
role: Study Director
affiliation: University of São Paulo General Hospital
facility: 
country: Brazil
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.
PMID: 32702276
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.
PMID: 20334633
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.
PMID: 18091006
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.
PMID: 27841688
citation: Mahler DA, O'Donnell DE. Recent advances in dyspnea. Chest. 2015 Jan;147(1):232-241. doi: 10.1378/chest.14-0800.
PMID: 25560861
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.
PMID: 21398686
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.
PMID: 27624705
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.
PMID: 11713359
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.
PMID: 19750325
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.
PMID: 28640172
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.
PMID: 25410838
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No