Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359770
• Other study ID #: FUniversity of Paraíba
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: September 2022
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Inspiratory Muscle Training
• Respiratory Aspiration
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Device:
• Active 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.
• Control 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.

Locations

Country	Name	City	State
Brazil	Suellen Andrade, pHD	João Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
Suellen Marinho Andrade

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal inspiratory pressure	Maximal inspiratory pressure response to inspiratory muscle training in association with diaphragmatic motor cortex neurostimulation	From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary	Functional capacity	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.	From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary	Forced vital capacity (FVC), forced expiratory volume 1st second (FEV1) and peak expiratory flow (PEF) by spirometry	Data of pulmonary function given by FCV, FEV1 and PEF will be assessed before and after pulmonary responses using spirometry	From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary	Inflammatory biomarkers	Correlate levels of inflammatory markers (interleukin-6 and C-reactive protein) with inspiratory muscle training and/or diaphragmatic motor cortex neurostimulation	From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary	Body composition by bioelectrical impedance	Body composition analysis (body fat composition, muscle mass composition, body mass index) will be carried out by bioelectrical impedance analysis	From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary	Depression level with Hamilton Anxiety Rating Scale (score 0 to 58)	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.	From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)