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Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

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ClinicalTrials.gov Identifier: NCT02811146
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
BRUNA THAYS SANTANA DE ARAÚJO, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Bilevel Positive Pressure Airway Other: Heart rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811146


Contacts
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Contact: Bruna Thays Araújo 997961625 brunathays.araujo@gmail.com

Locations
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Brazil
Cardiopulmonary Physiotherapy Laboratory Recruiting
Recife, Pernambuco, Brazil, 50740-560
Contact: DANIELLA BRANDÃO    81981359335    daniellacunha@hotmail.com   
Contact: JÉSSICA LEITE    83988667323    jcl.15@hotmail.com   
Principal Investigator: BRUNA ARAÚJO         
Hospital of the Clinics Federal University of Pernambuco Recruiting
Recife, PE, Brazil, 50670-901
Contact: BRUNA THAYS S DE ARAÚJO    81997961625    brunathays.araujo@gmail.com   
Contact: JÉSSICA LEITE    83988667323    jcl.15@hotmail.com   
Sponsors and Collaborators
Universidade Federal de Pernambuco
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Responsible Party: BRUNA THAYS SANTANA DE ARAÚJO, physiotherapist, clinical research, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02811146    
Other Study ID Numbers: 54735716.3.0000.5208
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by BRUNA THAYS SANTANA DE ARAÚJO, Universidade Federal de Pernambuco:
Heart Failure
Noninvasive Ventilation
Positive- Pressure Respiration
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases