Effects of an Inspiratory Muscle Training Protocol Associated With Neurological Stimulation by HD-tDCS on the Diaphragmatic Cortex in Post-COVID-19 Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Maximal inspiratory pressure
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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))
Investigators
Suellen Marinho Andrade
Principal Investigator
Federal University of Paraíba