Inspiratory Muscle Training in COVID-19 Patients

Escola Superior de Ciencias da Saude138 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

138

Conditions

Covid19 Exercise

Interventions

inspiratory muscle traiingDEVICE

The patients are encouraged to inhale against a load to increase the inspiratory muscle strength and endurance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Secretaria de Saúde do Distrito Federal

Brasília, Federal District, Brazil

Outcomes

Primary Outcomes

Cardiopulmonary Exercise Testing Measurements

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.

Time frame: change from baseline in Peak VO2, VE/VCO2 slope and VAT at 8 weeks and 6 months

Secondary Outcomes

severity of fatigue

Fatigue severity scale (FSS) is a questionnaire consisting of 9 questions showing the degree of fatigue of patients. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome

Time frame: change from baseline in FSS score at 8 weeks and 6 months

Anxiety and Depression

Hospital anxiety and depression scale (HADS) is a 14-item questionnaire for screening anxiety (7 items) and depression (7 items). Each item is scored from 0-3 (a 4-point severity scale). Highest anxiety or depression score is 21. Patients are defined as having anxiety or depression or both if the score is 8 or more in the each subscale.

Time frame: Change from baseline in HADS score at 8 weeks and 6 months

incremental cost-utility ratio

Utility will be measured by Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.

Time frame: 6 months

Data from ClinicalTrials.gov

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