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Clinical Trials/NCT05359770
NCT05359770
Recruiting
Not Applicable

Effects of an Inspiratory Muscle Training Protocol Associated With Neurological Stimulation by HD-tDCS on the Diaphragmatic Cortex in Post-COVID-19 Subjects

Suellen Marinho Andrade1 site in 1 country30 target enrollmentSeptember 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronavirus
Sponsor
Suellen Marinho Andrade
Enrollment
30
Locations
1
Primary Endpoint
Maximal inspiratory pressure
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue), neurological complications and and mainly disorders of the respiratory system, such as respiratory muscle weakness after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation (tDCS) have been proposed to minimize functional and structural impairments. The aim of the present study is to evaluate the effects of inspiratory muscle training associated with stimulation of the diaphragmatic motor cortex through hd-tdcs in post-COVID-19 patients on inspiratory muscle strength, pulmonary function, inflammatory levels and functional capacity.

Registry
clinicaltrials.gov
Start Date
September 22, 2021
End Date
December 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Suellen Marinho Andrade
Responsible Party
Sponsor Investigator
Principal Investigator

Suellen Marinho Andrade

Principal Investigator

Federal University of Paraíba

Eligibility Criteria

Inclusion Criteria

  • Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled.

Exclusion Criteria

  • Those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.

Outcomes

Primary Outcomes

Maximal inspiratory pressure

Time Frame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)

Maximal inspiratory pressure response to inspiratory muscle training in association with diaphragmatic motor cortex neurostimulation

Secondary Outcomes

  • Inflammatory biomarkers(From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1))
  • Functional capacity(From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1))
  • Forced vital capacity (FVC), forced expiratory volume 1st second (FEV1) and peak expiratory flow (PEF) by spirometry(From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1))
  • Depression level with Hamilton Anxiety Rating Scale (score 0 to 58)(From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1))
  • Body composition by bioelectrical impedance(From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1))

Study Sites (1)

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