Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

NCT ID: NCT02811146

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-07-01

Brief Summary

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cardiopulmonary exercise testing

Assess whether people who wore noninvasive ventilation during aerobic exercise have greater functional capacity than those who did not wear.

Group Type: EXPERIMENTAL

Bilevel Positive Pressure Airway

Intervention Type: DEVICE

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

Heart rehabilitation

Intervention Type: OTHER

Heart rehabilitation, for 12 weeks, 3 times a week

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. .

Group Type: EXPERIMENTAL

Bilevel Positive Pressure Airway

Intervention Type: DEVICE

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

Heart rehabilitation

Intervention Type: OTHER

Heart rehabilitation, for 12 weeks, 3 times a week

Minnesota Living with Heart Failure

Check if people undergoing heart rehabilitation has improved quality of life.

Group Type: EXPERIMENTAL

Bilevel Positive Pressure Airway

Intervention Type: DEVICE

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

Heart rehabilitation

Intervention Type: OTHER

Heart rehabilitation, for 12 weeks, 3 times a week

Bioimpedance balance

Check if people undergoing heart rehabilitation has improved the body composition.

Group Type: EXPERIMENTAL

Bilevel Positive Pressure Airway

Intervention Type: DEVICE

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

Heart rehabilitation

Intervention Type: OTHER

Heart rehabilitation, for 12 weeks, 3 times a week

Six-minute walk test

Compare a ventilatory metabolic response of the six-minute walk test with an ADL Glitre test.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Bilevel Positive Pressure Airway

Intervention Type: DEVICE

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

Heart rehabilitation

Intervention Type: OTHER

Heart rehabilitation, for 12 weeks, 3 times a week

Interventions

Bilevel Positive Pressure Airway

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

Intervention Type: DEVICE

Heart rehabilitation

Heart rehabilitation, for 12 weeks, 3 times a week

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

BRUNA THAYS SANTANA DE ARAÚJO

physiotherapist, clinical research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital of the Clinics Federal University of Pernambuco

Recife, Pernambuco, Brazil

Cardiopulmonary Physiotherapy Laboratory

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

54735716.3.0000.5208

Identifier Type: -

Identifier Source: org_study_id