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

September 1, 2022 updated by: Suellen Marinho Andrade

Effects of an Inspiratory Muscle Training Protocol Associated With Neurological Stimulation by HD-tDCS on the Diaphragmatic Cortex in Post-COVID-19 Subjects

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraíba
      • João Pessoa, Paraíba, Brazil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Device: 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.
Other Names:
  • Sham control
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
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.
Device: 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.
Other Names:
  • Sham control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal inspiratory pressure
Time Frame: 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
From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity
Time Frame: 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.
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
Time Frame: 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
From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Inflammatory biomarkers
Time Frame: 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
From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Body composition by bioelectrical impedance
Time Frame: 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
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)
Time Frame: 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.
From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suellen Marinho Andrade

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 22, 2021

Primary Completion (ACTUAL)

August 20, 2022

Study Completion (ANTICIPATED)

December 20, 2022

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (ACTUAL)

May 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUniversity of Paraíba

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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