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Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bilevel Positive Pressure Airway
Heart rehabilitation
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Noninvasive Ventilation, Positive- Pressure Respiration

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiopulmonary Physiotherapy Laboratory
  • Hospital of the Clinics Federal University of Pernambuco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Experimental

Arm Label

Cardiopulmonary exercise testing

ADL Glitre test

Minnesota Living with Heart Failure

Bioimpedance balance

Six-minute walk test

Metabolic ventilatory response

Arm Description

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

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. .

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

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

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

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.

Outcomes

Primary Outcome Measures

Cardiopulmonary exercise testing
Change in functional capacity
Glittre-ADL Test
Change in submaximal functional capacity
Six-Minute Walk Test
Change in submaximal functional capacity
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

Secondary Outcome Measures

Minnesota Living with Heart Failure
Improved in quality of life
Bioimpedance scale
Change in the body composition

Full Information

First Posted
June 2, 2016
Last Updated
October 4, 2021
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02811146
Brief Title
Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Noninvasive Ventilation, Positive- Pressure Respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiopulmonary exercise testing
Arm Type
Experimental
Arm Description
Assess whether people who wore noninvasive ventilation during aerobic exercise have greater functional capacity than those who did not wear.
Arm Title
ADL Glitre test
Arm Type
Experimental
Arm Description
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. .
Arm Title
Minnesota Living with Heart Failure
Arm Type
Experimental
Arm Description
Check if people undergoing heart rehabilitation has improved quality of life.
Arm Title
Bioimpedance balance
Arm Type
Experimental
Arm Description
Check if people undergoing heart rehabilitation has improved the body composition.
Arm Title
Six-minute walk test
Arm Type
No Intervention
Arm Description
Compare a ventilatory metabolic response of the six-minute walk test with an ADL Glitre test.
Arm Title
Metabolic ventilatory response
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bilevel Positive Pressure Airway
Intervention Description
Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week
Intervention Type
Other
Intervention Name(s)
Heart rehabilitation
Intervention Description
Heart rehabilitation, for 12 weeks, 3 times a week
Primary Outcome Measure Information:
Title
Cardiopulmonary exercise testing
Description
Change in functional capacity
Time Frame
Baseline and 12 weeks
Title
Glittre-ADL Test
Description
Change in submaximal functional capacity
Time Frame
Baseline and 12 weeks
Title
Six-Minute Walk Test
Description
Change in submaximal functional capacity
Time Frame
Baseline
Title
Ventilatory metabolic response during the 6-minute walk test (6MWT) and Glittre-ADL Test
Description
Compare the ventilatory metabolic response of the six-minute walk test and Glittre-ADL Test
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Minnesota Living with Heart Failure
Description
Improved in quality of life
Time Frame
Baseline and 12 weeks
Title
Bioimpedance scale
Description
Change in the body composition
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Cardiopulmonary Physiotherapy Laboratory
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740-560
Country
Brazil
Facility Name
Hospital of the Clinics Federal University of Pernambuco
City
Recife
State/Province
PE
ZIP/Postal Code
50670-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

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