Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

NCT02811146 | Completed DMC

• 1 other identifier: 54735716.3.0000.5208
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

Heart Failure; Noninvasive Ventilation; Positive- Pressure Respiration

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Minnesota Living with Heart Failure

  Baseline and 12 weeks

• Bioimpedance scale

  Baseline and 12 weeks

Study Arms (6)

Cardiopulmonary exercise testing

EXPERIMENTAL

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; Other: Heart rehabilitation

ADL Glitre test

EXPERIMENTAL

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; Other: Heart rehabilitation

Minnesota Living with Heart Failure

EXPERIMENTAL

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

Device: Bilevel Positive Pressure Airway; Other: Heart rehabilitation

Bioimpedance balance

EXPERIMENTAL

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

Device: Bilevel Positive Pressure Airway; Other: Heart rehabilitation

Six-minute walk test

NO INTERVENTION

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

Metabolic ventilatory response

EXPERIMENTAL

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; Other: Heart rehabilitation

Interventions

Bilevel Positive Pressure Airway DEVICE

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

ADL Glitre test; Bioimpedance balance; Cardiopulmonary exercise testing; Metabolic ventilatory response; Minnesota Living with Heart Failure

Heart rehabilitation OTHER

Heart rehabilitation, for 12 weeks, 3 times a week

ADL Glitre test; Bioimpedance balance; Cardiopulmonary exercise testing; Metabolic ventilatory response; Minnesota Living with Heart Failure

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (2)

Hospital of the Clinics Federal University of Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

Cardiopulmonary Physiotherapy Laboratory

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Continuous Positive Airway Pressure; Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist, clinical research

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 23, 2016
• Study Start: July 1, 2016
• Primary Completion: May 31, 2021
• Study Completion: July 1, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

BR (2)