Coronavirus, COVID-19, Inspiratory Muscle Training, Respiratory Infection
Conditions
Keywords
Transcranial direct current stimulation, Non-invasive brain stimulation, Inspiratory muscle training, Functional capacity, Maximal inspiratory pressure
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.
Interventions
DEVICEActive HD-tDCS
Experimental group: 10-sessions of anodal HD-tDCS ( tDCS 1x1, developed by Soterix Medical Inc.) associated to respiratory training; for 20 minutes (each session). It will be delivered a 3mA intensity electrical current accordingly 10/20 International System on cortical representation zone of left diaphragmatic motor cortex using HD-tDCS.
DEVICEControl group
Sham Control: 10-sessions of anodal HD-tDCS( tDCS 1x1, developed by Soterix Medical Inc.) associated to respiratory training; for 20 minutes (each session) with a 3mA intensity. The device will provide a 30-second ramp-up followed immediately by a 30-second ramp down.
Sponsors
Suellen Marinho Andrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal inspiratory pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity | From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1) | Compare baseline to treatment responses in the distance covered on the 6-minute walk test (6MWT). Its measurement has focused on the examination on a broader health indicator than morbidity, as it is correlated with quality of life. |
| 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) | Data of pulmonary function given by FCV, FEV1 and PEF will be assessed before and after pulmonary responses using spirometry |
| Inflammatory biomarkers | From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1) | Correlate levels of inflammatory markers (interleukin-6 and C-reactive protein) with inspiratory muscle training and/or diaphragmatic motor cortex neurostimulation |
| Body composition by bioelectrical impedance | From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1) | Body composition analysis (body fat composition, muscle mass composition, body mass index) will be carried out by bioelectrical impedance analysis |
| 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) | Anxiety level will be evaluate through Hamilton Anxiety Rating Scale which measures the severity of anxiety symptoms in a score 0 to 58. In current practice, it is accepted that scores greater than 25 points characterize severely depressed patients, scores between 18 and 24 points characterize moderately depressed patients, and scores between 7 and 17 points characterize patients with mild depression. |
Countries
Brazil
Outcome results
None listed