Clinical trial NCT05359770: Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19
Official title: Effects of an Inspiratory Muscle Training Protocol Associated With Neurological Stimulation by HD-tDCS on the Diaphragmatic Cortex in Post-COVID-19 Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus
Inspiratory Muscle Training
Respiratory Infection
COVID-19
Keywords: Transcranial direct current stimulation
Non-invasive brain stimulation
Inspiratory muscle training
Functional capacity
Maximal inspiratory pressure
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximal inspiratory pressure
timeFrame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary outcomes:
measure: Functional capacity
timeFrame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
measure: Forced vital capacity (FVC), forced expiratory volume 1st second (FEV1) and peak expiratory flow (PEF) by spirometry
timeFrame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
measure: Inflammatory biomarkers
timeFrame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
measure: Body composition by bioelectrical impedance
timeFrame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
measure: Depression level with Hamilton Anxiety Rating Scale (score 0 to 58)
timeFrame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Suellen Andrade, pHD
state: Paraíba
Study officials:
References: