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

NCT05359770 | Unknown

• 1 other identifier: FUniversity of Paraíba
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functional capacity

  From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)

• 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)

• Inflammatory biomarkers

  From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)

• Body composition by bioelectrical impedance

  From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)

• 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)

Study Arms (2)

Experimental

EXPERIMENTAL

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.

Device: Active HD-tDCS; Device: Control group

Sham Comparator

SHAM COMPARATOR

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

Device: Active HD-tDCS; Device: Control group

Interventions

Active HD-tDCS DEVICE

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.

Experimental; Sham Comparator

Control group DEVICE

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.

Also known as: Sham control

Experimental; Sham Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suellen Marinho Andrade: lead

Study Sites (1)

Suellen Andrade, pHD

João Pessoa, Paraíba, Brazil

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections; Respiratory Tract Infections; COVID-19

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: May 4, 2022
• Study Start: September 22, 2021
• Primary Completion: August 20, 2022
• Study Completion: December 20, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

BR (1)