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

Not Applicable

Recruiting

• Conditions: Coronavirus; COVID-19; Inspiratory Muscle Training; Respiratory Infection
• Interventions: Device: Active HD-tDCS; Device: Control group

• 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

Study Timeline

• Study Start: 2021-09-22
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-04
• Primary Completion: 2022-08-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-02
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Active HD-tDCS	Experimental: Experimental Group/ Active HD-tDCS Patients randomly enrolled in this group will receive 10 sessions of anodal HD-tDCS stimulation on cortical representation zone of left diaphragmatic motor cortex associated to respiratory training; for 20 minutes (each session) with a 2mA intensity. The electrical current will be delivered with a ramp-up time of 30 s, held at 3mA for 20 min, and then ramped down over 30 s.
Experimental	Control group	Experimental: Experimental Group/ Active HD-tDCS Patients randomly enrolled in this group will receive 10 sessions of anodal HD-tDCS stimulation on cortical representation zone of left diaphragmatic motor cortex associated to respiratory training; for 20 minutes (each session) with a 2mA intensity. The electrical current will be delivered with a ramp-up time of 30 s, held at 3mA for 20 min, and then ramped down over 30 s.
Sham Comparator	Active HD-tDCS	Sham Comparator: Control Group / Sham Group In the sham condition, the device will provide a 30-second ramp-up followed immediately by a 30-second ramp down in HD-tDCS associated with inspiratory muscle training for 20 minutes
Sham Comparator	Control group	Sham Comparator: Control Group / Sham Group In the sham condition, the device will provide a 30-second ramp-up followed immediately by a 30-second ramp down in HD-tDCS associated with inspiratory muscle training for 20 minutes

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