Effects of IMT on Functional Capacity in Patients With Chronic COVID After Hospital Discharge

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2022
Exercise intolerance and fatigue are the most common symptoms in patients with chronic COVID after hospital discharge. Muscle deconditioning, dysautonomia, and exercise hyperventilation have been proposed as potential mechanisms contributing to exercise functional capacity limitation in Long-COVID. Along this line, combined exercise training or inspiratory muscle training (IMT) alone have already been demonstrated to be feasible therapeutic options for Long-COVID patients. However, we do not have evidence about the effects of a home-based IMT program for 12-week on peak oxygen consumption (peakVO2). in patients chronic COVID (\>3 months) after hospital discharge. This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a program of IMT that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12-week. Patients with chronic COVID (\>3 months) after hospital discharge will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +3 mL/kg/min (SD±2.5)\] of 26 patients (13 per arm) would be necessary to test our hypothesis.
Epistemonikos ID: f5e0c4c76faedb9db6236f5b32b2fe53189671b7
First added on: Mar 16, 2022