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

NCT02600000 | Unknown DMC

• 1 other identifier: 38572614.1.3001.5192
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change from Submaximal functional capacity

  Change from Baseline and Three months after

• Mobility of the diaphragm

  Change from Baseline and Three months after

• Diaphragm thickness

  Change from Baseline and Three months after

Study Arms (4)

Sympathetic myocardial activity after IMT

EXPERIMENTAL

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

Maximal functional capacity after IMT

EXPERIMENTAL

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

submaximal functional capacity after IMT

EXPERIMENTAL

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

Thickness and mobility of the diaphragm after IMT

EXPERIMENTAL

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

Interventions

Myocardial scintigraphy RADIATION

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

Sympathetic myocardial activity after IMT

Cardiopulmonary test DEVICE

Assessment of maximal functional capacity

Maximal functional capacity after IMT

AVD-Glittre Test DEVICE

Evaluation of submaximal functional capacity after inspiratory muscle training.

submaximal functional capacity after IMT

Diaphragm ultrasound DEVICE

Evaluation of thickness and diaphragmatic mobility

Thickness and mobility of the diaphragm after IMT

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Physiology laboratory and cardiopulmonary physiotherapy

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 32532283 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Daniella C Brandão, Doctor

CONTACT

+55 81 998036255; daniellacunha@hotmail.com

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: PRINCIPAL INVESTIGATOR
• PI Title: Master's Degree student

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 9, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

BR (1)