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Completed

NCT Number: NCT04595097

Inspiratory Muscle Training in COVID-19 Patients

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.

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Key information

Conditions

Covid19 Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Exercise Infections Lung Diseases Motor Activity Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Secretaria de Saúde do Distrito Federal

Brasília, Federal District, 700000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

inspiratory muscle traiing

Device

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

Other names: tapered flow resistive loading

Primary outcomes

  1. 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

  1. severity of fatigue

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

    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

  2. Anxiety and Depression

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

    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.

  3. incremental cost-utility ratio

    Time frame: 6 months

    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.

  4. Health- related quality of life

    Time frame: change from baseline in EQ-5D score at 8 weeks and 6 months

    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

  5. Pulmonary function testing

    Time frame: change from baseline in FEV1 and FVC in Liters at 8 weeks and 6 months.

    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).

  6. Dyspnea

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

    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.

  7. Respiratory muscle strength

    Time frame: change from baseline in MIP and MEP at 8 weeks and 6 months

    Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements

  8. Postural Control

    Time frame: change from baseline in Postural stability test and fall risk test at 8 weeks

    postural control assessed by stabilometry test

  9. isometric knee extension strength

    Time frame: change from baseline in Nm at 8 weeks

    peripheral muscle stregnth assessed by isometric load dynamometer

  10. displacement

    Time frame: change from baseline in CM2 at 8 weeks

    outcomes assessed by baropodometry

  11. trajectory

    Time frame: change from baseline in CM2 at 8 weeks

    outcome assessed by baropodometry

  12. isometric knee flexion strength

    Time frame: change from baseline in Nm at 8 weeks

    peripheral muscle stregnth assessed by isometric load dynamometer

  13. dynamic balance

    Time frame: change from baseline in Total score at 8 weeks

    dynamic balance assessed by Mini-BEST testing

  14. Sit to Stand Test

    Time frame: change from baseline in repetitions at 8 weeks

    exercise capacity assessed by Sit to Stand test

Sponsors and collaborators

Lead sponsor

Escola Superior de Ciencias da Saude

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • University of Brasilia

Registry information

Official study title

Adjunctive Inspiratory Muscle Training for Patients With COVID-19

Acronym: ADDIMTCOVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2020
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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