Adjunctive Inspiratory Muscle Training for Patients With COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- Cardiopulmonary Exercise Testing Measurements
Study Overview
Brief Summary
This study aims to investigate whether adjunctive inspiratory muscle training (IMT) can enhance the benefits of pulmonary rehabilitation (PR) in patients with COVID-19. 120 patients will be randomized into an interventional group (PR plus IMT) and a control group (sham IMT plus PR). Improvement in quality of life, peak VO2 and VE/VCO2 slope will be defined as a primary outcome. Maximal inspiratory pressure, inspiratory muscle endurance, pulmonary function testing, severity of fatigue, cost-effectiveness and six minute walk test will be defined as the secondary outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be eligible, participants must be:
- •over 18 years of age
- •confirmed COVID-19 diagnosis
- •Individuals that required hospitalization and either i) non-invasive respiratory support (CPAP, high-flow oxygen catheter, non-breathing oxygen mask, or ii) invasive mechanical ventilation within three months of study recruitment.
Exclusion Criteria
- •Pregnancy
- •Dependence on others to perform activities of daily living during the month prior to the current ICU admission (gait aids are acceptable)
- •documented cognitive impairment
- •Proven or suspected spinal cord injury, or other neuromuscular diseases that will result in a permanent or prolonged weakness (not including ICU acquired weakness)
- •Severe neurological disease
- •Death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision-maker are not committed to full active treatment.
Outcomes
Primary Outcomes
Cardiopulmonary Exercise Testing Measurements
Time Frame: change from baseline in Peak VO2, VE/VCO2 slope and VAT at 8 weeks and 6 months
Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.The ventilatory anaerobic threshold (VAT) will be determined by the V-slope method.
Secondary Outcomes
- Anxiety and Depression(Change from baseline in HADS score at 8 weeks and 6 months)
- Pulmonary function testing(change from baseline in FEV1 and FVC in Liters at 8 weeks and 6 months.)
- Postural Control(change from baseline in Postural stability test and fall risk test at 8 weeks)
- trajectory(change from baseline in CM2 at 8 weeks)
- severity of fatigue(change from baseline in FSS score at 8 weeks and 6 months)
- Dyspnea(change from baseline in mMRC score at 8 weeks and 6 months)
- displacement(change from baseline in CM2 at 8 weeks)
- dynamic balance(change from baseline in Total score at 8 weeks)
- Respiratory muscle strength(change from baseline in MIP and MEP at 8 weeks and 6 months)
- Sit to Stand Test(change from baseline in repetitions at 8 weeks)
- incremental cost-utility ratio(6 months)
- Health- related quality of life(change from baseline in EQ-5D score at 8 weeks and 6 months)
- isometric knee extension strength(change from baseline in Nm at 8 weeks)
- isometric knee flexion strength(change from baseline in Nm at 8 weeks)
Investigators
Vinicius Zacarias Maldaner da silva
PhD
Escola Superior de Ciencias da Saude