Inspiratory Muscle Training in COVID-19 Patients

Covid19 Clinical Trial

— ADDIMTCOVID  

Official title:

Adjunctive Inspiratory Muscle Training for Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595097
• Other study ID #: CNPQ092020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Escola Superior de Ciencias da Saude
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Exercise
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Brazil	Secretaria de Saúde do Distrito Federal	Brasilia	DF

Sponsors (3)

Lead Sponsor	Collaborator
Escola Superior de Ciencias da Saude	JBS/CNPq, University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change from baseline in Peak VO2, VE/VCO2 slope and VAT at 8 weeks and 6 months
Secondary	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	change from baseline in FSS score at 8 weeks and 6 months
Secondary	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.	Change from baseline in HADS score at 8 weeks and 6 months
Secondary	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.	6 months
Secondary	Health- related quality of life	EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually	change from baseline in EQ-5D score at 8 weeks and 6 months
Secondary	Pulmonary function testing	Spirometry will be performed with a spirometer (Microlab 3.500; CareFusion, Yorba Linda, CA, USA). Three forced expiration maneuvers will be performed for validity and reproducibility purposes according to ATS/ERS criteria, with patients sitting, in a room with controlled temperature, ambient pressure, and relative humidity. The following variables will be analyzed: (a) forced vital capacity (FVC, L), (b) forced expiratory volume in the first second (FEV1, L).	change from baseline in FEV1 and FVC in Liters at 8 weeks and 6 months.
Secondary	Dyspnea	The modified Medical Research Council Dyspnea Scale (mMRC). A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are to breathless to leave the house, or breathless when dressing/undressing.	change from baseline in mMRC score at 8 weeks and 6 months
Secondary	Respiratory muscle strength	Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements	change from baseline in MIP and MEP at 8 weeks and 6 months
Secondary	Postural Control	postural control assessed by stabilometry test	change from baseline in Postural stability test and fall risk test at 8 weeks
Secondary	isometric knee extension strength	peripheral muscle stregnth assessed by isometric load dynamometer	change from baseline in Nm at 8 weeks
Secondary	displacement	outcomes assessed by baropodometry	change from baseline in CM2 at 8 weeks
Secondary	trajectory	outcome assessed by baropodometry	change from baseline in CM2 at 8 weeks
Secondary	isometric knee flexion strength	peripheral muscle stregnth assessed by isometric load dynamometer	change from baseline in Nm at 8 weeks
Secondary	dynamic balance	dynamic balance assessed by Mini-BEST testing	change from baseline in Total score at 8 weeks
Secondary	Sit to Stand Test	exercise capacity assessed by Sit to Stand test	change from baseline in repetitions at 8 weeks