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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Costal Mobilization Techniques and Manual Diaphragm Release Technique in Patients COPD

NCT03022942

Copd Chest Disorders Diaphragmatic Disorder

COMPLETED NA

Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease

NCT00870246

Chronic Obstructive Pulmonary Disease

COMPLETED

Heart Failure Worsens Muscle Strength in COPD

NCT04261452

COPD CHF Muscle Weakness

COMPLETED NA

Pursed-lips Breathing and Dynamic Hyperinflation

NCT02203058

Chronic Obstructive Pulmonary Disease

COMPLETED NA

Eccentric Training in Individuals With COPD

NCT04785469

Copd

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Slow chest compression

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

Group Type EXPERIMENTAL

Slow chest compression

Intervention Type 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".

No slow chest compression

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

Group Type PLACEBO_COMPARATOR

No slow chest compression

Intervention Type 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".

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Slow chest compression

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".

Intervention Type OTHER

No slow chest compression

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No