Clinical trial NCT02600000: Inspiratory Muscle Training Effectiveness in Sympathetic Activity and Functional Capacity in Patients With Heart Failure
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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;

Primary outcomes:
measure: Adrenergic tone of the heart muscle
timeFrame: Change from Baseline and Three months after
measure: Change from Functional capacity
timeFrame: Change from Baseline and Three months after
Secondary outcomes:
measure: Change from Submaximal functional capacity
timeFrame: Change from Baseline and Three months after
measure: Mobility of the diaphragm
timeFrame: Change from Baseline and Three months after
measure: Diaphragm thickness
timeFrame: Change from Baseline and Three months after
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Physiology laboratory and cardiopulmonary physiotherapy
state: Pernambuco
Study officials:
References:
citation: 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.