跳至主要内容
临床试验/NCT02600000
NCT02600000Unknown不适用

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

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Adrenergic tone of the heart muscle

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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;

排除标准

  • 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;

研究组 & 干预措施

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

干预措施: Myocardial scintigraphy (Radiation)

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

干预措施: Cardiopulmonary test (Device)

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

干预措施: AVD-Glittre Test (Device)

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.

干预措施: Diaphragm ultrasound (Device)

结局指标

主要结局

Adrenergic tone of the heart muscle

时间窗: Change from Baseline and Three months after

Measured by the integrity and activity of the sympathetic nervous pre synaptic terminals.

Change from Functional capacity

时间窗: Change from Baseline and Three months after

Measured by cardiopulmonary exercise testing

次要结局

  • Diaphragm thickness(Change from Baseline and Three months after)
  • Change from Submaximal functional capacity(Change from Baseline and Three months after)
  • Mobility of the diaphragm(Change from Baseline and Three months after)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jéssica Costa Leite

Master's Degree student

Universidade Federal de Pernambuco

研究点 (2)

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