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

NCT04415957 | Completed DMC

• 1 other identifier: ETPADCOPD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; dyspnea; respiratory mechanics; exercise capacity; physical activity; elastic tape

Outcome Measures

Primary Outcomes (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.

  Change from baseline physical activity levels after 14 days of intervention

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

Elastic Tape Group (ETG)

EXPERIMENTAL

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.

Other: Elastic Tape

Control Group (CG)

NO INTERVENTION

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.

Interventions

Elastic Tape OTHER

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.

Elastic Tape Group (ETG)

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Sao Paulo: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, 05360-160, Brazil

Location

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

  PMID: 25560861 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavior

Study Officials

• Celso RF Carvalho, PhD

  University of São Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: June 4, 2020
• Study Start: February 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)