Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Pursed-lips Breathing Reduces Reduces Dynamic Hyperinflation Induced by Activities of Daily Living Test in Patients With COPD
Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and
consequent limitations in functional capacity of chronic obstructive pulmonary disease
(COPD) patients. It has not been completely elucidated whether pursed-lips breathing (PLB)
is able to minimize DH and its effects on exercise tolerance in these patients. The aim of
this study was to evaluate the acute effect of PLB on DH and functional capacity in patients
with COPD.
Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient
pulmonary rehabilitation program in Florianópolis, Brazil.
Subjects: Twenty-five patients with COPD (16 men, mean age 64 (7) years, FEV1=41.7 (14.7)%
predicted, BMI=27.6 (5.13)kg/m2).
Interventions: Patients will randomly perform two six-minute walk tests with and without PLB
(6MWTPLB and 6MWTNon-PLB) and two Glittre-ADL tests with and without PLB (TGlittrePLB and
TGlittreNon-PLB).
Main measures: At baseline and immediately after the tests, the inspiratory capacity (IC)
will be assessed by the slow vital capacity (SVC) maneuver.
Pulmonary function testing Lung function will be tested using an Easy One spirometer (NDD
Medical Technologies Inc., Zurich, Switzerland), and calibration checked before each
evaluation. Spirometry will be performed in accordance with ATS/ERS standards (Miller et al,
2005). The predicted values will be calculated from the equations proposed by Pereira et al.
(2007).
Inspiratory capacity (IC) measurement IC will be measured with the patient in the sitting
position, using an Easy One portable spirometer (NDD Medical Technologies Inc., Zurich,
Switzerland), before and immediately after the tests, by the slow vital capacity 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 reproducible, two curves could not vary by more than 5% or 150mL. The
higher value of two reproducible curves will be used for analysis. DH is considered when the
IC decreased 10% and/or 150mL or more compared to the basal value (O'Donnell et al, 2001).
Six-minute walk test The 6MWT will be performed according to the guidelines of the American
Thoracic Society (2002). Pulse oxygen saturation (SpO2; Oxi-Go, Oximeter Plus, Roslyn
Heights, New York, USA) and dyspnea (Borg CR10 scale) will be measured at the beginning and
at the end of the test. Predicted values for walking distance will be calculated according
to Iwama et al. (2009).
Glittre-ADL test The TGlittre consists of completing a circuit as follows: from a sitting
position, the subject stands up and walks along a flat 10-m long course, in the middle of
which there is a two-step ladder (each step 17 cm high x 27 cm deep) to be climbed; after
completing the 10 m, the subject faces a shelf containing three 1-kg objects positioned on
the top shelf (shoulder height) and moves them one by one to the bottom shelf (waist height)
and then to the floor; the objects are then returned to the bottom shelf and finally to the
top shelf again; the subject walks back, climbing up and down the steps, until reaching the
starting point (chair), sits down and immediately begins the next lap. The subjects carry a
weighted backpack (2.5 kg for women, 5.0 kg for men) and are instructed to complete five
laps on this circuit as quickly as possible. SpO2 and dyspnea index (Borg CR10 scale) will
be measured at the beginning of the test, at the end of each lap, and at the end of the test
(Skumlien et al, 2006).
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
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