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

Primary Purpose

Coronavirus, Inspiratory Muscle Training, Respiratory Infection

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active HD-tDCS
Control group
Sponsored by
Suellen Marinho Andrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus focused on measuring Transcranial direct current stimulation, Non-invasive brain stimulation, Inspiratory muscle training, Functional capacity, Maximal inspiratory pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Suellen Andrade, pHDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental

Sham Comparator

Arm Description

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: 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

Outcomes

Primary Outcome Measures

Maximal inspiratory pressure
Maximal inspiratory pressure response to inspiratory muscle training in association with diaphragmatic motor cortex neurostimulation

Secondary Outcome Measures

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.
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
Inflammatory biomarkers
Correlate levels of inflammatory markers (interleukin-6 and C-reactive protein) with inspiratory muscle training and/or diaphragmatic motor cortex neurostimulation
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
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.

Full Information

First Posted
March 22, 2022
Last Updated
September 1, 2022
Sponsor
Suellen Marinho Andrade
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1. Study Identification

Unique Protocol Identification Number
NCT05359770
Brief Title
Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Suellen Marinho Andrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Suellen Andrade, pHD
City
João Pessoa
State/Province
Paraíba
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade, PhD
Phone
986046032
Email
suellenandrade@gmail.com
First Name & Middle Initial & Last Name & Degree
Tainá Cordeiro
Phone
+5583986681691
Email
iaratainacordeiro@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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