Slow Chest Compression on Dynamic Hyperinflation, Dyspnea and Peripheral Muscle Deoxygenation in Patients With COPD

NCT02746536 | Completed

• 1 other identifier: SCC2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Commonly, patients with chronic obstructive pulmonary disease (COPD) present dyspnea, dynamic hyperinflation (DH) and important peripheral muscle deoxygenation when performing their activities of daily living (ADLs). The slow chest compression (SCC) technique is a physiotherapy strategy that could maybe reduce DH, dyspnea and peripheral muscle deoxygenation in patients with COPD. The aim of the study is to analyse the effects of SCC in DH, dyspnea and peripheral muscle deoxygenation induced by exercise tests. The secondary objective was to identify responders and non-responders to the technique. Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation program in Florianopolis, Brazil Subjects: Patients with COPD (GOLD 2-4). Interventions: Patients will randomly receive or not the SCC after six-minute step test (6MST-SCC and 6MST-NonSCC). Main measures: At baseline and 1 minute after the tests, the inspiratory capacity (IC) will be assessed by the slow vital capacity (SVC) maneuver. At baseline, immediately after, and 1 minute after the tests, the dyspnea score will be assessed. The physiological responses and the peripheral muscle deoxygenation will be assessed during the tests and 1 minute after them.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Inspiratory capacity; Exercise

Outcome Measures

Primary Outcomes (3)

• Patients with COPD will perform the inspiratory capacity (IC) by the slow vital capacity (SVC) maneuver in order to measure dynamic hyperinflation (DH).

  Dynamic hyperinflation will be considered an increase of 150 ml or 10% on EELV after 6MST and 6MWT. End-expiratory lung volume (EELV) will be measured by the difference between total lung capacity and IC.

  Change from baseline and exactly 1 minute after the 6MST and 6MWT

• Patients with COPD will answer dyspnea score by modified Borg scale

  Change from baseline, after the completion of each 6MST and 6MWT and exactly 1 minute after the SCC or non-SCC.

• Patients with COPD will be monitored regarding peripheral muscle oxygenation by the near-infrared spectroscopy

  Change from baseline, after the completion of each 6MST and 6MWT and exactly 1 minute after the SCC or non-SCC.

Study Arms (2)

Slow chest compression

EXPERIMENTAL

Patients will receive the slow chest compression for one minute, immediately after 6MST.

Other: Slow chest compression

No slow chest compression

PLACEBO COMPARATOR

Immediately after 6MST, the patient will not receive the SCC and will remain seated at rest for one minute, without any intervention.

Other: No slow chest compression

Interventions

Slow chest compression OTHER

During the SCC, the patient will remain in the sitting position; a bimanual slow compression on his/her upper chest will be performed always by the same evaluator, who will stand behind the patient. This compression will be done only in the expiratory phase, during one minute, in all respiratory cycles, respecting the chest mobility of each patient. A standardized verbal command will be given: "Exhale all the air".

Slow chest compression

No slow chest compression OTHER

The patient will remain seated at rest for one minute after the 6MST. A standardized verbal command will be given: "Exhale all the air".

No slow chest compression

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages B, C and D)
• Absence of change in respiratory symptoms in the past four weeks
• No hospital admission in the past 12 weeks
• Age between 40 and 80 years-old

You may not qualify if:

• Any other disease or health condition that could compromise the test´s execution
• Participation in pulmonary rehabilitation program completed in the last six months
• Current smoking or its cessation in less than six months
• Any change in symptoms during the study protocol

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Núcleo de Assistência, Ensino e Pesquisa em Reabilitação Pulmonar

Florianópolis, Santa Catarina, Brazil

Location

Related Publications (8)

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 BACKGROUND

• Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.

  PMID: 17982531 BACKGROUND

• O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.

  PMID: 11549531 BACKGROUND

• Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.

  PMID: 16135736 BACKGROUND

• Neder JA, Andreoni S, Castelo-Filho A, Nery LE. Reference values for lung function tests. I. Static volumes. Braz J Med Biol Res. 1999 Jun;32(6):703-17. doi: 10.1590/s0100-879x1999000600006.

  PMID: 10412549 BACKGROUND

• da Costa JN, Arcuri JF, Goncalves IL, Davi SF, Pessoa BV, Jamami M, Di Lorenzo VA. Reproducibility of cadence-free 6-minute step test in subjects with COPD. Respir Care. 2014 Apr;59(4):538-42. doi: 10.4187/respcare.02743. Epub 2013 Sep 17.

  PMID: 24046461 BACKGROUND

• Pessoa BV, Arcuri JF, Labadessa IG, Costa JN, Sentanin AC, Di Lorenzo VA. Validity of the six-minute step test of free cadence in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2014 May-Jun;18(3):228-36. doi: 10.1590/bjpt-rbf.2014.0041.

  PMID: 25003275 BACKGROUND

• Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30.

  PMID: 25359356 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Anamaria F Mayer, PhD

  University of the State of Santa Catarina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 21, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: immediately following publication and ending 5 years following article publication
• Access Criteria: With Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose to achieve aims in the approved proposal; proposals should be directed to anamaria.mayer@udesc.br to gain access.

Locations

BR (1)