ClinicalTrials.Veeva

Menu

Non Invasive Ventilation on Peripheral Muscle Function and Aerobic Performance (NIV)

U

Universidade Federal do Rio Grande do Norte

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Other: Non-invasive ventilation bi-level
Other: Non-invasive ventilation placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05417503
1a2b3c4d5e6f7g

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

14 participants in 2 patient groups, including a placebo group

bi-level
Experimental group
Treatment:
Other: Non-invasive ventilation bi-level
placebo
Placebo Comparator group
Treatment:
Other: Non-invasive ventilation placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems