Inspiratory Muscle Training Effectiveness in Sympathetic Activity and Functional Capacity in Patients With Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-12-31

Brief Summary

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Heart failure (HF) is configured major problem for public health in the country. Affected individuals may experience fatigue, dyspnea, respiratory muscle weakness, overstimulation of the sympathetic myocardial activity, among others. In relation to the treatment of patients with heart failure with symptoms mentioned above a great alternative is the implantation of cardiac rehabilitation programs, these programs can also be associated with other muscle training measures, among these there is inspiratory muscle training (IMT), as the weakness of these muscles is rather found in this population and this directly related to signs and symptoms. OBJECTIVE: To evaluate the efficacy of inspiratory muscle training associated with a cardiac rehabilitation program in the modulation of sympathetic myocardial activity and maximal and submaximal functional capacity of patients with HF between 21-60 years. METHODOLOGY: This is a clinical trial, controlled, randomized, double-blind being developed in partnership with the Department of Physical Therapy, Federal University of Pernambuco (UFPE) and the Hospital das Clinicas (HC) of Pernambuco, whose patients will be accrued on the Recife's main referral centers in caring for patients with heart failure. Patients will undergo the evaluation of pulmonary function and respiratory muscle strength (spirometry and digital Manovacuometry) as well as on the functional capacity (Ergospirometry), cardiac innervation (myocardial scintigraphy), mobility and diaphragm thickness (ultrasound) and quality of life. After the evaluation will be randomly allocated into two groups: The control group will perform cardiac rehabilitation associated with the Sham of IMT, and the experimental group cardiac rehabilitation associated with the IMT at 30% of maximal inspiratory pressure. The intervention will last three months for both groups and after this phase patients will be submitted again to the assessment tools. EXPECTED RESULTS: To clarify the association between physical exercise associated with specific respiratory training in modulating the autonomic nervous system of patients with HF and what the relationship with reflected cardiorespiratory fitness in maximal and submaximal functional capacity.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sympathetic myocardial activity after IMT

Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the modulation of sympathetic myocardial activity of patients with HF

Group Type EXPERIMENTAL

Myocardial scintigraphy

Intervention Type RADIATION

Myocardial scintigraphy with Iodo123-Metaiodobenzylguanidine (MIBG) to assess the Sympathetic myocardial activity

Maximal functional capacity after IMT

Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the maximal functional capacity of patients with HF

Group Type EXPERIMENTAL

Cardiopulmonary test

Intervention Type DEVICE

Assessment of maximal functional capacity

submaximal functional capacity after IMT

Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the submaximal functional capacity of patients with HF

Group Type EXPERIMENTAL

AVD-Glittre Test

Intervention Type DEVICE

Evaluation of submaximal functional capacity after inspiratory muscle training.

Thickness and mobility of the diaphragm after IMT

Assess the impact of Inspiratory Muscle Training in combination with a cardiac rehabilitation program on the thickness and mobility of the diaphragm in patients with heart failure.

Group Type EXPERIMENTAL

Diaphragm ultrasound

Intervention Type DEVICE

Evaluation of thickness and diaphragmatic mobility

Interventions

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Myocardial scintigraphy

Myocardial scintigraphy with Iodo123-Metaiodobenzylguanidine (MIBG) to assess the Sympathetic myocardial activity

Intervention Type RADIATION

Cardiopulmonary test

Assessment of maximal functional capacity

Intervention Type DEVICE

AVD-Glittre Test

Evaluation of submaximal functional capacity after inspiratory muscle training.

Intervention Type DEVICE

Diaphragm ultrasound

Evaluation of thickness and diaphragmatic mobility

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Heart Failure;
* Lower left ventricular ejection fraction 45% (LVEF \<45%) assessed by simple and recent echocardiogram;
* Functional Class II and III by the New York Heart Association (NYHA)
* Clinically stable;
* Ex-smokers over five years;
* Maximal inspiratory pressure (MIP) \<70% of predicted;
* Forced expiratory volume/Forced vital capacity (FEV1 / FVC) \> 70% of predicted;

Exclusion Criteria

* Unstable angina;
* Myocardial infarction and heart surgery up to three months before the survey;
* Chronic respiratory diseases;
* Hemodynamic instability;
* Trauma recent face, nausea and vomiting.
* Orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and Cardiac Rehabilitation exercises;
* Psychological and / or cognitive impairments that restrict them to respond to questionnaires;

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No