Effect of overload and relief of air excess in the lungs on exercise capacity in people with Pulmonary Chronic Obstructive Lung Disease

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-82qrd2
• Date of registration: 31/03/2015
• Prospective Registration: No
• Primary sponsor: Universidade Federal de Mato Grosso do Sul
• Public title: Effect of overload and relief of air excess in the lungs on exercise capacity in people with Pulmonary Chronic Obstructive Lung Disease
• Scientific title: Effects of pulmonary hyperinflation on the kinetics of oxygen uptake in patients with Chronic Obstructive Pulmonary Disease
• Date of first enrolment: 03/03/2014
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-82qrd2
• Study type: Intervention
• Study design: Clinical diagnostic trial, single group, open and prospective
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Paulo de Tarso Müller
• Affiliation: Universidade Federal de Mato Grosso do Sul

• Name: Paulo de Tarso Müller
• Affiliation: Universidade Federal de Mato Grosso do Sul

Key inclusion & exclusion criteria

Inclusion criteria: We will test 21 patients to reach a final eligible 7 patients with Chronic Obstructive Pulmonary Disease stage severe or very-severe and aged 40 to 75 years ; free of exacerbation for at least 2 months; on regular use of prescription drugs; should be able to perform spirometry and exercise testing; both gender; without important comorbidities like other chronic obstructive lung disease or cardiopathy; free of chronic domiciliar oxygen therapy
Exclusion criteria: Patient with ischemic heart disease ; recent myocardial infarction; pulmonary arterial hypertension; uncontrolled systemic hypertension; diabetes mellitus or anemia ; furthermore can not participate in the study patients with severe aortic stenosis or musculoskeletal or rheumatic diseases and inability to use cycle ergometer for any reason

Age minimum: 40Y
Age maximum: 75Y
Gender: -

Health Condition(s) or Problem(s) studied

J44.9

Chronic Obstructive Pulmonary Disease

Intervention(s)

E02.041.625.591

Device

Each patient of a total of 21 participants will be subjected to two tests or interventions at rest and four cardiopulmonary exercise testing. The first test, at rest (randomized by simple draw) will be on a first visit, or a test of tachypnea of 40 breaths in 30 seconds with serial measurements of inspiratory capacity after this maneuver (hyperinflation) or, on a second visit, a test of 10 minutes under continuous positive airway pressure (CPAP) ventilatory mode with serial measurements of inspiratory capacity after the intervention (Deflation) .In another visit, patients who experience minimal change in volume of 200 mL by hyperinflation and / or those who submit minimum of 200 mL of lung deflation will undergo exercises at constant load tests preceded by 30 seconds before the beginning of the same positive tests already performed previously (tachypnea or CPAP) and duplicate at the same day, with a rest interval of 1 hours, having been previously submitted to a test without intervention.

Other

C08.618.501

E05.333

Primary Outcome(s)

Kinetics of oxygen consumption before and after intervention like time constant ; a monoexponential kinetics will be measured by analyzing the adjustment of oxygen consumption by measuring specific mathematical parameters such time constant, time delay and amplitude of the response; we expect to find an increase about 10% of the time constant and a reduction in amplitude of the same magnitude after tachypnea-induced hyperinflation and a reduction of the same magnitude for both after pre-exercise non invasive ventilation

Secondary Outcome(s)

Exercise time after the intervention, set on a cycle ergometer at a load of 70 to 80% of the maximum load reached in the incremental test, measured in minutes; we expect to reach a increase of 10% of this time after deinflation of the lungs by non invasive ventilation and a decrease in average 10% of this time in the case of induced hyperventilation and hyperinflation

Source(s) of Monetary Support

Universidade Federal de Mato Grosso do Sul

Secondary Sponsor(s)

Universidade Federal de Mato Grosso do Sul