Inspiratory Muscle Training in COVID-19 Patients

NCT04595097 | Completed

• 1 other identifier: CNPQ092020
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Exercise

Keywords

respiratory function tests; inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• severity of fatigue

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

• Anxiety and Depression

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

• incremental cost-utility ratio

  6 months

• Health- related quality of life

  change from baseline in EQ-5D 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

The training volume will be 24 sessions. Training frequency will be 3 sessions per week. Duration of training sessions will be around 60min. Patients will perform endurance training or interval training at moderate to high intensities. IMT in both groups will be performed using the PowerBreathe KHP2 device (POWERbreatheKHP2, HaB, International, Southam, UK). Training intensity in the intervention group will be set initially at a load of 50% of patients' maximal inspiratory mouth pressure (MIP). This initial load will be continuously and gradually increased to the highest tolerable intensity during each of the supervised sessions.

Device: inspiratory muscle traiing

Control group

ACTIVE COMPARATOR

The training volume will be 24 sessions. Training frequency will be 3 sessions per week. Duration of training sessions will be around 60min. Patients will perform endurance training or interval training at moderate to high intensities. Sham IMT will be performed using the PowerBreathe KHP2 device (POWERbreatheKHP2, HaB, International, Southam, UK). Training intensity in the control group will be set at 10% baseline PImax and will be not modified throughout the intervention period.

Device: inspiratory muscle traiing

Interventions

inspiratory muscle traiing DEVICE

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

Also known as: tapered flow resistive loading

Control group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Ciencias da Saude: lead
• University of Brasilia: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Secretaria de Saúde do Distrito Federal

Brasília, Federal District, 700000, Brazil

Location

Related Publications (1)

• Maldaner V, Coutinho J, Santana ANDC, Cipriano GFB, Oliveira MC, Carrijo MM, Lino MEM, Cahalin LP, Lima AG, Borges R, Santos DB, Silva IO, Oliveira LVF, Cipriano G Jr. Adjunctive inspiratory muscle training for patients with COVID-19 (COVIDIMT): protocol for randomised controlled double-blind trial. BMJ Open. 2021 Sep 22;11(9):e049545. doi: 10.1136/bmjopen-2021-049545.

  PMID: 34551948 DERIVED

MeSH Terms

Conditions

COVID-19; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 20, 2020
• Study Start: March 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

BR (1)