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Completed

NCT Number: NCT02811146

Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiopulmonary Physiotherapy Laboratory, Recife, Pernambuco, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bilevel Positive Pressure Airway

Device

Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week

Heart rehabilitation

Other

Heart rehabilitation, for 12 weeks, 3 times a week

Primary outcomes

  1. Cardiopulmonary exercise testing

    Time frame: Baseline and 12 weeks

    Change in functional capacity

  2. Glittre-ADL Test

    Time frame: Baseline and 12 weeks

    Change in submaximal functional capacity

  3. Six-Minute Walk Test

    Time frame: Baseline

    Change in submaximal functional capacity

  4. 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 outcomes

  1. Minnesota Living with Heart Failure

    Time frame: Baseline and 12 weeks

    Improved in quality of life

  2. Bioimpedance scale

    Time frame: Baseline and 12 weeks

    Change in the body composition

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2016
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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