Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

Overview

The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2020

Detailed Description

BACKGROUND: Heart failure (HF) is a cardiovascular syndrome with enormous impact on public health by high morbidity and mortality rates that are associated. Studies show that changes in striated skeletal muscle of those individuals, possibly caused by progressive physical inactivity, contribute to the construction of the pathophysiology of this disease, emphasizing the importance of exercise for these patients. Exercise programs can be traced safer and related form the actual functional capacity thereof. Cardiac rehabilitation it is a set of activities that aims to ensure that patients with heart disease the best conditions, especially physical. In this context, non-invasive ventilation (NIV) is an alternative to provide an improved tolerance during exercise in patients with HF.

GOALS: Evaluate the effectiveness of the use of NIV association to aerobic exercise in exercise programs supervised during cardiac rehabilitation exercise tolerance and quality of life in patients with heart failure when compared to performing these exercises without ventilatory support.

METHODS: This is a clinical trial, controlled, randomized and blind to be developed with patients arising out of the main Recife reference centers in the care of patients with heart failure. It will be conducted assessments of functional capacity made by cardiopulmonary exercise testing (CPET), the Glittre-ADL test and through the questionnaire Duke Activity Status Index (DASI), assessment of quality of life using the questionnaire Minnesota Living with Heart Failure (MLWHF), and finally, in order to determine a clinical change, will be used to Patient Global Impression of Change Scale (PGIS).

EXPECTED RESULTS: This study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.

Interventions

  • Device: Bilevel Positive Pressure Airway
    • Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week
  • Other: Heart rehabilitation
    • Heart rehabilitation, for 12 weeks, 3 times a week

Arms, Groups and Cohorts

  • Experimental: Cardiopulmonary exercise testing
    • Assess whether people who wore noninvasive ventilation during aerobic exercise have greater functional capacity than those who did not wear.
  • Experimental: ADL Glitre test
    • Check that people who wore noninvasive ventilation during aerobic exercise have greater submaximal functional capacity than those who did not wear. Compare a ventilatory metabolic response of the ADL Glitre test with an six-minute walk test. .
  • Experimental: Minnesota Living with Heart Failure
    • Check if people undergoing heart rehabilitation has improved quality of life.
  • Experimental: Bioimpedance balance
    • Check if people undergoing heart rehabilitation has improved the body composition.
  • No Intervention: Six-minute walk test
    • Compare a ventilatory metabolic response of the six-minute walk test with an ADL Glitre test.
  • Experimental: Metabolic ventilatory response
    • To verify if non-invasive ventilation during aerobic exercise modifies the ventilatory metabolic response in patients with heart failure. Check the metabolic ventilatory response during the Glittre ADL test and six-minute walk test.

Clinical Trial Outcome Measures

Primary Measures

  • Cardiopulmonary exercise testing
    • Time Frame: Baseline and 12 weeks
    • Change in functional capacity
  • Glittre-ADL Test
    • Time Frame: Baseline and 12 weeks
    • Change in submaximal functional capacity
  • Six-Minute Walk Test
    • Time Frame: Baseline
    • Change in submaximal functional capacity
  • Ventilatory metabolic response during the 6-minute walk test (6MWT) and Glittre-ADL Test
    • Time Frame: Baseline and 12 weeks
    • Compare the ventilatory metabolic response of the six-minute walk test and Glittre-ADL Test

Secondary Measures

  • Minnesota Living with Heart Failure
    • Time Frame: Baseline and 12 weeks
    • Improved in quality of life
  • Bioimpedance scale
    • Time Frame: Baseline and 12 weeks
    • Change in the body composition

Participating in This Clinical Trial

Inclusion Criteria

  • Sedentary adults diagnosed with heart failure of ischemic hypertensive or alcoholic etiology;
  • Ejection fraction of the left ventricle smaller than 50% (LVEF <50%) assessed by echocardiography simple;
  • Recent and functional class II and III by the New York Heart Association (NYHA);
  • FEV1 <80% predicted and / or FEV1 / FVC> 70% predicted;
  • Clinical stability; Ex-smokers for more than five years;
  • No change in the class of drugs within three months prior to the beginning of the study.

Exclusion Criteria

  • Patients with unstable angina;
  • Myocardial infarction or heart surgery up to three months before the survey;
  • FEV1 / FVC <70% predicted characterizing obstructive respiratory disorder;
  • Respiratory diseases;
  • Smoking;
  • Hemodynamic instability;
  • Trauma of recent face;
  • Nausea and vomiting;
  • Orthopedic and neurological diseases;
  • Psychic changes that restrict them to respond to the questionnaire.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidade Federal de Pernambuco
  • Provider of Information About this Clinical Study
    • Principal Investigator: BRUNA THAYS SANTANA DE ARAÚJO, physiotherapist, clinical research – Universidade Federal de Pernambuco
  • Overall Contact(s)
    • Bruna Thays Araújo, 997961625, brunathays.araujo@gmail.com

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