Slow Chest Compression on Dynamic Hyperinflation, Dyspnea and Peripheral Muscle Deoxygenation in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Study type: Interventional

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.
    

Detailed description: 
      The period from August 2015 to April 2016 was designated to clinical trial design and to its
      submission/approval by the Human Research Ethics Committee. The recruitment of subjects and
      the study evaluations following described will be only initiated after registration and
      publication on the ClinicalTrials.gov platform.

      Pulmonary function tests:

        -  Lung function will be tested using a total body plethysmography (Eric Jaeger, Germany),
           and the calibration will be checked before each evaluation. Spirometry will be performed
           in accordance with American Thoracic Society and European Respiratory Society (ATS/ERS)
           standards (Miller et al., 2005; Wanger et al., 2005). The predicted values will be
           calculated with the equations derived from Brazilian population (Pereira et al., 2007;
           Neder et al., 1999).

        -  SVC maneuver: IC will be measured with the patient in the sitting position, using a
           portable spirometer (NDD Medical Technologies®, Switzerland), before and 1 minute after
           the tests, by the SVC maneuver starting from a stable end-expiratory volume, in
           accordance with ATS/ERS standards (Miller et al.,2005). A minimum of three maneuvers
           (maximum of eight) will be performed and, in order to be considered reliable, two curves
           could not vary more than 5% or 150 ml. The higher value of two reproducible curves will
           be used for analysis (O'Donnell et al., 2001). This outcome will be collected by a third
           evaluator blinded for the SCC or non-SCC application.

      Six-minute step test (6MST): The patients will be instructed to walk up and down the step in
      order to perform the largest number of steps during six minutes. The walking speed will be
      selected by the patient (da Costa et al., 2014;. Pessoa et al., 2014). Two 6MSTs will be
      conducted by two evaluators: the main evaluator will be responsible for conducting the tests
      and the other will count the number of steps performed by the patient.

      Dyspnea: Before and after the completion of each 6MST and each 6MWT, patients will be asked
      about their perception of dyspnea, using the modified Borg scale. Immediately after
      completion the SCC (or not), patients will be asked again about the dyspnea score. This
      outcome will be collected by a third evaluator blinded for the SCC or non-SCC application.

      Peripheral muscle oxygenation: During the tests, before and after the completion of each
      6MST, it will be measured the peripheral muscle oxygenation by near-infrared spectroscopy
      (NIRS) (Artinis Medical Systems®, Netherlands). The device will be positioned over the vastus
      lateralis muscle of dominant leg.

      Slow chest compression: The patient will receive in a randomized order the application or not
      of SCC for one minute immediately after 6MST. 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. For all patients, during SCC, it will be given a standardized
      verbal command: "Exhale all the air". After the test in which the patient will not receive
      the SCC, he/she must remain seated, at rest, for one minute without any interventions,
      although it will be given the same standardized verbal command.
    

Intervention name(s): Slow chest compression; No slow chest compression
Intervention type(s): Other; Other
Intervention description(s): 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".; The patient will remain seated at rest for one minute after the 6MST. A standardized verbal command will be given: "Exhale all the air".
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: COPD; Inspiratory capacity; Exercise