Non Invasive Ventilation on Peripheral Muscle Function and Aerobic Performance
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Other: Non-invasive ventilation placeboOther: Non-invasive ventilation bi-level
- Registration Number
- NCT05417503
- Lead Sponsor
- Universidade Federal do Rio Grande do Norte
- Brief Summary
Background: Non-invasive ventilation (NIV) reduces respiratory load and demands on peripheral muscles. Methods: This study aims to evaluate the acute effects of bi-level NIV on peripheral muscle function during isokinetic exercise and aerobic performance in chronic obstructive pulmonary disease (COPD) patients. This is a pilot crossover study performed with a non-probabilistic sample of 14 moderate to very severe COPD patients. Procedures carried out in two days. Dyspnea, quality of life, lung function, respiratory muscle strength, functional capacity (6-minute walk test - 6MWT), and isokinetic assessment of the quadriceps were assessed. Blood samples (lactate, lactate dehydrogenase, and creatine kinase concentration) were also collected. Right after, NIV was performed for 30 minutes (bi-level or placebo, according to randomization) followed by new blood sample collection, 6MWT, and isokinetic dynamometer tests. Before and after evaluations, the subjective perception of dyspnea and fatigue in the lower limbs was quantified. After a wash-out period of seven days, participants returned, and all assessments were performed again.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Clinically stable COPD patients (diagnosed according to the Global Initiative for Obstructive Lung Disease), of both sexes, without exacerbation or changes in medication for at least one month before the study, and no dyspnea during daily activities (grades 2, 3, and 4 of the Medical Research Council - MRC scale) were included.
- Those with a diagnosis of neoplasia, orthopedic or neurological conditions affecting exercise capacity, peripheral arterial obstructive disease, heart failure, kidney or liver disease, did not adapt, or failed to complete the study procedures, were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description placebo Non-invasive ventilation placebo - bi-level Non-invasive ventilation bi-level -
- Primary Outcome Measures
Name Time Method Lung function change from baseline and 30 minutes after intervention Lung function was assessed using a spirometer (Koko Digidoser, Longmont, USA), according to the American Thoracic Society/European Throracic Society recommendations14. At least three tests were performed, with a variation of less than 5%, and the highest value obtained was compared with predicted values for the Brazilian population.
Functional capacity change from baseline and 30 minutes after intervention The 6-minute walk test (6MWT) was performed in a flat 30-m corridor, according to the ATS recommendations17. Subjects were instructed to keep walking for six minutes, and standardized verbal incentives were given each minute. The perception of dyspnea (using the 10-point Borg scale) were assessed at rest, at the end of the 6MWT, and two minutes after the test. In this test, the walked distance (in meters) was considered for analysis.
Disease severity change from baseline and 30 minutes after intervention COPD severity was assessed using the BODE index (body mass index \[B\], degree of airway obstruction \[O\], dyspnea \[D\], and exercise capacity \[E\]). For each variable, the following scores were assigned: body mass index (BMI), from 0 to 1 point; degree of airflow obstruction (FEV1% predicted), from 0 to 3 points; dyspnea (MRC scale), from 0 to 3 points; exercise capacity (walked distance in the 6MWT), from 0 to 3 points. The final score of the index ranges from 0 to 10, with higher scores indicating greater disease severity.
Respiratory muscle strength change from baseline and 30 minutes after intervention Respiratory muscle strength was assessed using a digital manometer (MVD 300 - Brazil). Maximum inspiratory and expiratory pressures were performed from residual volume and total lung capacity, respectively, and values were compared with previously reference values for the Brazilian population
COPD Assessement Test change from baseline and 30 minutes after intervention The Portuguese version of the COPD Assessment Test (CAT) questionnaire was used to assess the quality of life. Subjects were instructed to choose only one option in each item of the questionnaire (cough, phlegm, chest tightness, breathlessness, limited activities, confidence leaving home, sleeplessness, and energy). Item scores range from 0 to 5 points resulting in a total score ranging from 0 to 40 points. The clinical impact of COPD was assessed according to the following stratification: mild (6-10), moderate (11-20), severe (21-30), and very severe (31-40)20.
- Secondary Outcome Measures
Name Time Method Quadriceps femoris performance change from baseline and 30 minutes after intervention QF (Quadriceps femoris) strength was evaluated with subjects performing 20 repetitions at the same speed. The protocol established was designed to reach a fatigue threshold in the QF muscle. Dyspnea and perceived level of exertion (Borg scale) were also assessed before and after isokinetic evaluation.
Biochemical analyzes change from baseline and 30 minutes intervention Before and after procedures, venous blood samples were collected by a blinded experienced pharmacist to analyze lactate, LDH enzyme, and CK (creatine kinase) concentration. Samples were processed, centrifuged at 3000 rpm for 15 minutes at room temperature. The serum concentration was assessed using a specific enzyme kit for each biomarker, following manufacturer's recommendations.
Trial Locations
- Locations (1)
Federal University of Rio Grande do Norte
🇧🇷Natal, Rio Grande Do Norte, Brazil