NCT05417503

Non Invasive Ventilation on Peripheral Muscle Function and Aerobic Performance

Acute Effects of NIV on Peripheral Muscle Function and Aerobic Performance in Patients With Chronic Obstructive Pulmonary Disease: a Piloty Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Universidade Federal do Rio Grande do Norte · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
OTHER	Non-invasive ventilation bi-level	For the NIV intervention, two levels of positive airway pressure (bi-level) were used: the positive inspiratory airway pressure (IPAP) was fixed at 6 cmH2O (centimeters of water), which could be gradually increased up to 14 cmH2O (2 cmH2O every minute), depending on the patient's comfort. and gradually increased to 14 cmH2O (2 cmH2O every minute), While the expiratory airway pressure (EPAP) was set at 3 cmH2O, it could be gradually increased up to 7 cmH2O (1 cmH2O every minute), depending on the patient's comfort.while expiratory airway pressure (EPAP) was fixed at 3 cmH2O and gradually increased to 7 cmH2O (1 cmH2O every minute).
OTHER	Non-invasive ventilation placebo	The same pressure chosen by the subject during adaptation was used in the placebo intervention; however, a T tube was connected between the equipment and the circuit, creating a leak and leaving the circuit open. The tube characteristics were: 22 x 18 x 22 mm nebulizer T-connector.

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-01-24
• Completion: 2018-02-28
• First posted: 2022-06-14
• Last updated: 2022-06-14

Locations

1 site across 1 country: Brazil