Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811146
• Other study ID #: 54735716.3.0000.5208
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2021
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Brazil	Cardiopulmonary Physiotherapy Laboratory	Recife	Pernambuco
Brazil	Hospital of the Clinics Federal University of Pernambuco	Recife	PE

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary exercise testing	Change in functional capacity	Baseline and 12 weeks
Primary	Glittre-ADL Test	Change in submaximal functional capacity	Baseline and 12 weeks
Primary	Six-Minute Walk Test	Change in submaximal functional capacity	Baseline
Primary	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	Minnesota Living with Heart Failure	Improved in quality of life	Baseline and 12 weeks
Secondary	Bioimpedance scale	Change in the body composition	Baseline and 12 weeks