Effect of Non-invasive Neurostimulation on Variability OF HEART RATE IN PATIENTS WITH HEART FAILURE.

Study Overview
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Brief Summary
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This study is a clinical trial, and may also be referred to as a before and after study, in which all subjects receive the same treatment and their condition is checked before initiation and after various times of treatment. This study will be carried out at the Laboratory of Physiotherapy in Cardiorespiratory Research, located in the building of the postgraduate course in physiotherapy at the Health Sciences Center (CCS) of the Federal University of Parahyba (UFPB), from May 2023 to May 2020. 2024. After screening, patients will undergo assessment and anthropometric measurements. Subsequently, interventions will be carried out

Detailed Description
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The patients will perform three sessions of HD-TDCS (stimulation, inhibition and Shan) of twenty minutes with an intensity of three milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated.

Official Title
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Effect of Non-invasive Neurostimulation on Variability of Heart Rate During the Six-minute Walk Test of Patients With Heart Failure: a Double-blinded Clinical Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Device: high definition transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of heart failure; over eighteen years old; classified in functional class II and III of the New York Heart Association. Exclusion Criteria: Patients with neurological or pulmonary diseases; Patients with cognitive alterations that make it impossible to execute commands; with physical limitations that prevent the performance of the exercise protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study is a clinical trial, and may also be called a before and after study, in which all subjects receive the same treatment and their condition is checked before beginning and after various moments of treatment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HD- TDCS (inhibition)<br>Patients will perform a session (inhibition) of HD-TDCS of twenty minutes with intensity of 3 milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated. | Device: high definition transcranial direct current stimulation<br>* Transcranial direct current stimulation, in recent decades, has been identified as a non-invasive tool for transiently modulating human brain activity. The technique consists of the application of a low-intensity continuous electric current, through electrodes applied to the scalp, acting in a regulatory way on the frequency of triggered action potentials, however, without interacting directly with the neurons.<br>* Other names: HD-tDCS;|
| Experimental: HD- TDCS (stimulation)<br>Patients will perform a session (stimulation) of HD-TDCS of twenty minutes with intensity of 3 milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated. | Device: high definition transcranial direct current stimulation<br>* Transcranial direct current stimulation, in recent decades, has been identified as a non-invasive tool for transiently modulating human brain activity. The technique consists of the application of a low-intensity continuous electric current, through electrodes applied to the scalp, acting in a regulatory way on the frequency of triggered action potentials, however, without interacting directly with the neurons.<br>* Other names: HD-tDCS;|
| Experimental: HD- TDCS (shan)<br>Patients will perform a twenty-minute session (SHAN) of HD-TDCS with an intensity of 3 milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated. | Device: high definition transcranial direct current stimulation<br>* Transcranial direct current stimulation, in recent decades, has been identified as a non-invasive tool for transiently modulating human brain activity. The technique consists of the application of a low-intensity continuous electric current, through electrodes applied to the scalp, acting in a regulatory way on the frequency of triggered action potentials, however, without interacting directly with the neurons.<br>* Other names: HD-tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Travelled distance | To analyze the distance walked by these patients after the six-minute walk test after the application of HD-Tdcs | day one | 
| heart rate variability | To evaluate the effects of HD-TDCS on the left temporal lobe - T3 on heart rate variability during the six-minute walk test in patients with heart failure | day one | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, transcranial direct current stimulation, six minute walk test