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

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ClinicalTrials.gov Identifier: NCT02600000
Recruitment Status : Recruiting
First Posted : November 9, 2015
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Jéssica Costa Leite, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
Heart Failure Radiation: Myocardial scintigraphy Device: Cardiopulmonary test Device: AVD-Glittre Test Device: Diaphragm ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : February 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Adrenergic tone of the heart muscle [ Time Frame: Change from Baseline and Three months after ]
    Measured by the integrity and activity of the sympathetic nervous pre synaptic terminals.

  2. Change from Functional capacity [ Time Frame: Change from Baseline and Three months after ]
    Measured by cardiopulmonary exercise testing


Secondary Outcome Measures :
  1. Change from Submaximal functional capacity [ Time Frame: Change from Baseline and Three months after ]
    Measured by Glittre Test

  2. Mobility of the diaphragm [ Time Frame: Change from Baseline and Three months after ]
    Reviewed from the ultrasound

  3. Diaphragm thickness [ Time Frame: Change from Baseline and Three months after ]
    Reviewed from the ultrasound



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600000


Contacts
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Contact: Daniella C Brandão, Doctor +55 81 998036255 daniellacunha@hotmail.com

Locations
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Brazil
Physiology laboratory and cardiopulmonary physiotherapy Recruiting
Recife, Pernambuco, Brazil, 50670-901
Contact: Jessica C Leite, graduate    +55 83 988667323    jesewev@gmail.com   
Sponsors and Collaborators
Universidade Federal de Pernambuco

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Responsible Party: Jéssica Costa Leite, Master's Degree student, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02600000     History of Changes
Other Study ID Numbers: 38572614.1.3001.5192
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases