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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05944874
Other study ID # 64878922.2.0000.5188
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 5, 2023
Est. completion date September 2024

Study information

Verified date July 2023
Source Federal University of Paraíba
Contact José Sr Heriston
Phone +55 (83)
Email joseheristonlima@yahoo.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
high definition transcranial direct current stimulation
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.

Locations

Country Name City State
Brazil University Hospital Lauro Wanderley João Pessoa Paraíba

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Travelled distance To analyze the distance walked by these patients after the six-minute walk test after the application of HD-Tdcs day one
Primary 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
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