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

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Radiation: Myocardial scintigraphy; Device: Cardiopulmonary test; Device: AVD-Glittre Test; Device: Diaphragm ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniella C Brandão, Doctor; Phone Number: +55 81 998036255; Email: daniellacunha@hotmail.com

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50670-901
      • Recruiting
      • Physiology laboratory and cardiopulmonary physiotherapy
      • Contact: Jessica C Leite, graduate; Phone Number: +55 83 988667323; Email: jesewev@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Radiation: Myocardial scintigraphy; Myocardial scintigraphy with Iodo123-Metaiodobenzylguanidine (MIBG) to assess the Sympathetic myocardial activity
EXPERIMENTAL: 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	Device: Cardiopulmonary test; Assessment of maximal functional capacity
EXPERIMENTAL: 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	Device: AVD-Glittre Test; Evaluation of submaximal functional capacity after inspiratory muscle training.
EXPERIMENTAL: 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.	Device: Diaphragm ultrasound; Evaluation of thickness and diaphragmatic mobility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from Functional capacity	Measured by cardiopulmonary exercise testing	Change from Baseline and Three months after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Submaximal functional capacity	Measured by Glittre Test	Change from Baseline and Three months after
Mobility of the diaphragm	Reviewed from the ultrasound	Change from Baseline and Three months after
Diaphragm thickness	Reviewed from the ultrasound	Change from Baseline and Three months after

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Publications and helpful links

General Publications

• Leite JC, Brandao DC, Brandao SCS, Fuzari HKB, Vidal TM, Frutuoso J, Remigio MI, de Araujo BTS, Campos SL, Dornelas de Andrade A. Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial. Trials. 2020 Jun 12;21(1):519. doi: 10.1186/s13063-020-04363-6.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (ESTIMATE): November 9, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 27, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 38572614.1.3001.5192