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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Bilevel Positive Pressure Airway; Other: Heart rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PE
    • Recife, PE, Brazil, 50670-901
      • Hospital of the Clinics Federal University of Pernambuco
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50740-560
      • Cardiopulmonary Physiotherapy Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiopulmonary exercise testing; Assess whether people who wore noninvasive ventilation during aerobic exercise have greater functional capacity than those who did not wear.	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
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. .	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
Experimental: Minnesota Living with Heart Failure; Check if people undergoing heart rehabilitation has improved quality of life.	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
Experimental: Bioimpedance balance; Check if people undergoing heart rehabilitation has improved the body composition.	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
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.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Heart Failure; Noninvasive Ventilation; Positive- Pressure Respiration
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 54735716.3.0000.5208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided