Non-invasive Neustimulation and Respiratory Rehabilitation

NCT05886647 | Unknown

• 1 other identifier: HD-tDCS+respiratory disorders
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Respiratory diseases are associated with high rate of morbidity and mortality in Brazil. Cardiopulmonary rehabilitation through respiratory muscle training, aerobic training and strengthening of upper and lower limbs emerges as one of the resources available for the treatment and monitoring of patients with respiratory diseases. To add in this perspective, the application of HD-tDCS induces significant neurophysiological and clinical effects in several body systems. Objective: To identify the chronic effects of non-invasive neurostimulation associated with the rehabilitation of patients with respiratory disorders. Material and methods: This is a pilot study, quantitative, clinical trial type, randomized and controlled, double blind. The sample will be composed by patients with respiratory diseases, aged above 18 years old. The study will consist of two groups: (1) HD-tDCS will be applied - anodic current + respiratory rehabilitation with respiratory muscle training (RMT) and (2) Sham - Only respiratory rehabilitation with RMT without any type of cortical stimulation. The chronic effects of neurostimulation by HD-tDCS associated with cardiopulmonary rehabilitation, with TMR, during 12 sessions will be evaluated. Patients will be evaluated, before and after the protocol, in relation to cortical activation function, pulmonary function, subjective perception of effort, respiratory muscle function, functional capacity, sensation of dyspnea and quality of life. For statistical analysis, intention-to-treat analysis will be used and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary outcomes. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Neurostimulation would enhance the effects of respiratory rehabilitation and reduce the symptoms of patients with these diseases.

Conditions

Lung Diseases

Keywords

Brain Stimulation; Performance; Exercise

Outcome Measures

Primary Outcomes (1)

• Lung function

  Spirometry will be performed following the American Thoracic criteria Society (ATS). All participants will undergo a minimum of three maneuvers, in a sitting position, with a nose clip and mouthpiece attached. It will be instructed to perform maximum inspiration, up to total lung capacity, followed by a maximal and continuous forced expiration for at least six seconds, until residual volume.

  six weeks

Secondary Outcomes (5)

• Maximum inspiratory pressure

  six weeks

• functional capacity

  six weeks

• dyspnea sensation

  six weeks

• health-related quality of life

  six weeks

• respiratory muscle resistance

  six weeks

Study Arms (2)

Group 1 experimental

EXPERIMENTAL

group composed by patients with respiratory disorders, which will undergo 12 sessions of neurostimulation by HD-tDCS 4x1 (tDCS 1x1, developed by Soterix Medical Inc.). A current of 3 mA will be provided, positioning a central electrode (anode) on the left diaphragmatic primary motor cortex (4 cm lateral to the midline and 1 cm anterior to the binaural line) and the four return electrodes in a radius of 8 cm to the around. At the same time, inspiratory muscle training (IMT) will be performed by KH2; PowerBreathe International Ltd. UK with visual feedback, consisting of three series of two minutes of maximum and deep inspirations followed by two minutes of rest between them, totaling six minutes of TMI. The initial load will be through the maximum inspiratory pressure (MIP) achieved in the initial evaluation, using 40% of the total MIP in the first three weeks and 70% of the protocol will be used 40% of the MIP in the remaining three weeks and 70% in the remaining weeks.

Other: Active non-invasive stimulation and inspiratory muscle training

Group 2 sham comparator

SHAM COMPARATOR

The participants allocated in the control group will receive the sham HD tDCS for 20 minutes associated with the IMT, following for this training the same load guidelines, duration and load increment used in the experimental group.

Other: Sham compatorator and inspiratory muscle training

Interventions

Active non-invasive stimulation and inspiratory muscle training OTHER

Simultaneously with the current application, the patient will perform inspiratory muscle training (IMT) by KH2; PowerBreathe International Ltd. UK along with a feedback Breathelink, consisting of three series of two minutes of maximum and deep inspirations followed by two minutes of rest between them, totaling six minutes of TMI.

Group 1 experimental

Sham compatorator and inspiratory muscle training OTHER

As for the patients allocated in the control group, they will receive the HD-tDCS sham for 20 minutes associated with IMT, following for the same training, duration and load increment used in the experimental group.

Group 2 sham comparator

Eligibility Criteria

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

You may qualify if:

• confirmed clinical diagnosis for respiratory disease;
• stable disease

You may not qualify if:

• develop disabling condition that prevents the implementation of the protocol;
• join another rehabilitation program

Sponsors & Collaborators

• Suellen Andrade: lead

Study Sites (1)

Federal University of Paraiba

João Pessoa, Paraíba, 51051900, Brazil

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Lung Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Behavior

Central Study Contacts

Suellen M Marinho dos Santos Andrade, Doctor

CONTACT

83 9 93812744; suellen.andrade@academico.ufpb.br

Eduardo E Tenório de França, Doctor

CONTACT

83 9 96575859; eduardo.eriko@academico.ufpb.br

Study Design

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

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 2, 2023
• Study Start: January 23, 2023
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: will become available as it is collected, and will be available for a period of two years.

Locations

BR (1)