Inspiratory Muscle Training in COVID-19 Patients

NCT ID: NCT04595097

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

inspiratory muscle traiing

Intervention Type: DEVICE

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

Control group

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.

Group Type: ACTIVE_COMPARATOR

inspiratory muscle traiing

Intervention Type: DEVICE

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

Interventions

inspiratory muscle traiing

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

Intervention Type: DEVICE

Other Intervention Names

tapered flow resistive loading

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Brasilia

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Escola Superior de Ciencias da Saude

OTHER

Sponsor Role: lead

Responsible Party

Vinicius Zacarias Maldaner da silva

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Secretaria de Saúde do Distrito Federal

Brasília, Federal District, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 34551948 (View on PubMed)

Other Identifiers

CNPQ092020

Identifier Type: -

Identifier Source: org_study_id