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Chronic Obstructive Pulmonary DiseaseCOPDNCT04415957

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

A study testing Elastic Tape in people with Chronic Obstructive Pulmonary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Elastic Tape
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
1 Feb 2019to 1 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • Undergoing pulmonary rehabilitation(PR);
  • Participating in other research studies;
  • Unability to understand our questionnaire.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Clinical Hospital of São Paulo University medical school (HCFMUSP)

    São Paulo, 05360-160

Other trials in Brazil

About this study

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

  • 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?

Read more

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).
Read the 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.

Being tested
Elastic Tape
Keywords
COPD, dyspnea, respiratory mechanics, exercise capacity, physical activity, elastic tape
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Dyspnea, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elastic TapeOther

    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.

Study groups in NCT04415957
Study groupRoleWhat they receive
Elastic Tape Group (ETG)ExperimentalThe 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.
Receives: Other: Elastic Tape
Control Group (CG)No interventionCG 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline physical activity levels after 14 days of intervention

Secondary outcomes (5)

  1. 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.

    Measured: Change from baseline dyspnea at 7th and 14th days of intervention

  2. 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.

    Measured: Change in health status after 14 days of intervention

  3. 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.

    Measured: Change in HRQoL after 14 days of intervention

  4. 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.

    Measured: Change from baseline anxiety and depression symptoms after 14 days of intervention

  5. 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.

    Measured: Change in barriers to DLPA after 14 days of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start1 Feb 2019
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04415957
Sponsor's protocol ID
ETPADCOPD
Acronym
COPD
Status last verified
Sep 2022
First submitted
17 Feb 2020
Last updated
16 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32702276

  • 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.

    PubMed 20334633

  • 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.

    PubMed 18091006

  • 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.

    PubMed 27841688

  • Mahler DA, O'Donnell DE. Recent advances in dyspnea. Chest. 2015 Jan;147(1):232-241. doi: 10.1378/chest.14-0800.

    PubMed 25560861

  • 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.

    PubMed 21398686

  • 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.

    PubMed 27624705

  • 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.

    PubMed 11713359

  • 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.

    PubMed 19750325

  • 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.

    PubMed 28640172

  • 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.

    PubMed 25410838

Questions about this trial

What is this clinical trial studying?

A study testing Elastic Tape in people with Chronic Obstructive Pulmonary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in daily life physical activity (DLPA) (time frame: Change from baseline physical activity levels after 14 days of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04415957, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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