Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19
- Conditions
- CoronavirusCOVID-19Inspiratory Muscle TrainingRespiratory Infection
- Registration Number
- NCT05359770
- Lead Sponsor
- Suellen Marinho Andrade
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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.
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
Trial Locations
- Locations (1)
Suellen Andrade, pHD
🇧🇷João Pessoa, Paraíba, Brazil
Suellen Andrade, pHD🇧🇷João Pessoa, Paraíba, Brazil