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

Heart Failure Clinical Trial

Official title:

Effectiveness of Inspiratory Muscle Training Associated With a Cardiac Rehabilitation Program in Sympathetic Activity and Functional Capacity in Patients With Heart Failure: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02600000
• Other study ID #: 38572614.1.3001.5192
• Status: Recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: Universidade Federal de Pernambuco
• Contact: Daniella C Brandão, Doctor
• Phone: +55 81 998036255
• Email: daniellacunha[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Device:
• Cardiopulmonary test
Assessment of maximal functional capacity
• AVD-Glittre Test
Evaluation of submaximal functional capacity after inspiratory muscle training.
• Diaphragm ultrasound
Evaluation of thickness and diaphragmatic mobility

Locations

Country	Name	City	State
Brazil	Physiology laboratory and cardiopulmonary physiotherapy	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adrenergic tone of the heart muscle	Measured by the integrity and activity of the sympathetic nervous pre synaptic terminals.	Change from Baseline and Three months after
Primary	Change from Functional capacity	Measured by cardiopulmonary exercise testing	Change from Baseline and Three months after
Secondary	Change from Submaximal functional capacity	Measured by Glittre Test	Change from Baseline and Three months after
Secondary	Mobility of the diaphragm	Reviewed from the ultrasound	Change from Baseline and Three months after
Secondary	Diaphragm thickness	Reviewed from the ultrasound	Change from Baseline and Three months after