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Cardiopulmonary Capacity and Quality of Life in Patients With Chronic Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Functional Training
Strength Training
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiopulmonary Capacity, Quality of Life, Functional Capacity, Functional Training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals resident in Porto Alegre and metropolitan area,
  • aged ≥ 18 years;
  • with diagnosis of heart failure class II and III (New York Heart Association);
  • clinically stable at least 3 months prior to the start of the study;
  • with left ventricular ejection fraction (LV) ≤ 45%;
  • under optimized pharmacological treatment;
  • with resting heart rate ˂ 120 bpm;
  • resting blood pressure ˂ 180 / 110mm Hg;
  • previously sedentary.

Exclusion Criteria:

  • Decompensated heart failure (evidenced by ascites, lower limb edema, jugular swelling and / or pulmonary wheezing);
  • individuals with decompensated metabolic diseases;
  • acute coronary syndrome (ACS);
  • survivors of sudden death;
  • with acute myocardial infarction (AMI) and / or cardiac surgery for less than 6 months; -
  • severe valvulopathies and / or cardiac arrhythmias;
  • presence of asymmetric septal hypertrophic cardiomyopathy with dynamic outlet obstruction;
  • with general contraindication criteria for performing the cardiopulmonary exercise test; -
  • musculoskeletal disorders that limit exercise performance;
  • with cognitive alterations that compromise the understanding of the stages and the execution of the research.

Sites / Locations

  • HCPortoAlegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Functional Training

Strength Training

Arm Description

Patients in the functional training group, in addition to maintaining their usual care, will perform functional training including exercises for core strength, power training, knee dominance, hip dominance, horizontal pressure, vertical pressure, horizontal pull and vertical pull, using unstable surfaces.

These group, in addition to maintaining their usual care, will perform the exercise protocol as recommended by the American Heart Association.

Outcomes

Primary Outcome Measures

Cardiopulmonary Capacity
Cardiopulmonary capacity assessed by peak oxygen consumption in treadmill cardiopulmonary exercise test.
Quality of life
Quality of life assessed by the Minnesota Living With Heart Failure Questionnaire. It is composed of 21 questions about limitations that are often associated with how heart failure interferes with patients' quality of life. The patient should consider the last month to answer the questions. The scale of responses for each question varies from 0 (zero) to 5, where 0 represents without limitations and 5, maximum limitation. These questions involve a physical dimension (from 1 to 7, 12 and 13 questions) that are highly interrelated with dyspnea and fatigue, an emotional dimension (17 to 21 questions) and other issues (8, 9, 10, 11, 14, 15 and 16 questions) which, added to the previous dimensions, form the total score. The scale totals 105 points. Higher values indicate maximum limitation and poorer quality of life.

Secondary Outcome Measures

Functionality
Functionality assessed by the Duke Activity Status Index
Gait Speed
Gait Speed assessed by the Gait Speed Test.
Palmar Grip Strength
Palmar grip strength evaluated by dynamometry.
Maximum Inspiratory Pressure
Maximum inspiratory pressure evaluated by manovacuometry.
Endothelial Function
Endothelial function evaluated by brachial artery ultrasonography.
Lean Body Mass
Lean body mass assessed by arm muscle circumference.

Full Information

First Posted
October 23, 2017
Last Updated
July 8, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03321682
Brief Title
Cardiopulmonary Capacity and Quality of Life in Patients With Chronic Heart Failure
Official Title
Cardiopulmonary Capacity and Quality of Life in Patients With Chronic Heart Failure Submitted to Functional Training - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Heart Failure is a progressive disorder that begins after an insult to the heart muscle resulting in the loss of functional cardiomyocytes, or even compromising the ability of the myocardium to contract and/or relax normally. A common finding in heart failure is exercise intolerance that generates a vicious cycle, in which the individual starts to limit his activities even further due to progressive fatigue. Studies demonstrate that regular physical exercise can increase the aerobic capacity of these individuals, delay the anaerobic threshold, and reestablish the sympathovagal balance. Paradoxically, many of these patients assume an even more sedentary lifestyle, which leads to a greater physical limitation and the progression of symptoms. Patients with heart failure present a 30% reduction in their ability to perform their daily life activities when compared to healthy individuals, and this has also been attributed to reduced muscle mass, as well as lower aerobic capacity. In this sense, strength training increases the torque and muscular endurance, capacity and functional independence, as well as the quality of life, reducing the morbidity of individuals with and without cardiovascular disease, with a lower overload to the cardiorespiratory system. It is known, however, that daily life activities require a combination of resistance and muscle strength. Aerobic training does not improve muscle strength, just as traditional strength training does not ideally represent the movements performed during daily life activities, since it does not include exercises on unstable surfaces and exercises on different axes. Functional training emerges as a simple and low cost alternative for the treatment of patients with heart failure. This method consists of integrated movements of the body, in several axes, involving joint acceleration and deceleration, stabilization, strength and neuromuscular efficiency. It aims to improve the functional capacity of the individual using exercises that relate to their specific physical activity, transferring their gains effectively to their daily lives. The aim of the present study is to evaluate the effects of functional training on cardiopulmonary capacity and quality of life in patients with heart failure, comparing it to strength training.
Detailed Description
Individuals with cardiac heart failure, in functional class II and III (according to the New York Heart Association), residents of the metropolitan region of Porto Alegre, of both genders and aged ≥ 18 years, will be recruited from the Outpatient Clinical of Heart Failure of the Hospital de Clínicas of Porto Alegre, RS/ Brazil. At the end of the initial evaluations of each participant, they will be randomly allocated in one of two groups: functional training group (FTG) and strength training group (STG). After the consent of the participants, the author of the research will start collecting the data, by completing an anamnesis form. The following evaluations will be performed before the start of the study and immediately after the end of the research, by prior appointment: cardiopulmonary capacity, quality of life, functionality, palmar grip strength, maximum inspiratory pressure, endothelial function and lean body mass. Both groups will perform the exercise training three times per week, during 12 weeks, totaling 36 sections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiopulmonary Capacity, Quality of Life, Functional Capacity, Functional Training

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Functional Training
Arm Type
Experimental
Arm Description
Patients in the functional training group, in addition to maintaining their usual care, will perform functional training including exercises for core strength, power training, knee dominance, hip dominance, horizontal pressure, vertical pressure, horizontal pull and vertical pull, using unstable surfaces.
Arm Title
Strength Training
Arm Type
Active Comparator
Arm Description
These group, in addition to maintaining their usual care, will perform the exercise protocol as recommended by the American Heart Association.
Intervention Type
Other
Intervention Name(s)
Functional Training
Intervention Description
Exercises performed in circuit, using weights, elastic bands, suspension tapes, cones and on unstable surfaces.
Intervention Type
Other
Intervention Name(s)
Strength Training
Intervention Description
Exercises carried out using weights and involving the main muscle groups.
Primary Outcome Measure Information:
Title
Cardiopulmonary Capacity
Description
Cardiopulmonary capacity assessed by peak oxygen consumption in treadmill cardiopulmonary exercise test.
Time Frame
After 12 weeks of training.
Title
Quality of life
Description
Quality of life assessed by the Minnesota Living With Heart Failure Questionnaire. It is composed of 21 questions about limitations that are often associated with how heart failure interferes with patients' quality of life. The patient should consider the last month to answer the questions. The scale of responses for each question varies from 0 (zero) to 5, where 0 represents without limitations and 5, maximum limitation. These questions involve a physical dimension (from 1 to 7, 12 and 13 questions) that are highly interrelated with dyspnea and fatigue, an emotional dimension (17 to 21 questions) and other issues (8, 9, 10, 11, 14, 15 and 16 questions) which, added to the previous dimensions, form the total score. The scale totals 105 points. Higher values indicate maximum limitation and poorer quality of life.
Time Frame
After 12 weeks of training.
Secondary Outcome Measure Information:
Title
Functionality
Description
Functionality assessed by the Duke Activity Status Index
Time Frame
After 12 weeks of training.
Title
Gait Speed
Description
Gait Speed assessed by the Gait Speed Test.
Time Frame
After 12 weeks of training.
Title
Palmar Grip Strength
Description
Palmar grip strength evaluated by dynamometry.
Time Frame
After 12 weeks of training.
Title
Maximum Inspiratory Pressure
Description
Maximum inspiratory pressure evaluated by manovacuometry.
Time Frame
After 12 weeks of training.
Title
Endothelial Function
Description
Endothelial function evaluated by brachial artery ultrasonography.
Time Frame
After 12 weeks of training.
Title
Lean Body Mass
Description
Lean body mass assessed by arm muscle circumference.
Time Frame
After 12 weeks of training.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals resident in Porto Alegre and metropolitan area, aged ≥ 18 years; with diagnosis of heart failure class II and III (New York Heart Association); clinically stable at least 3 months prior to the start of the study; with left ventricular ejection fraction (LV) ≤ 45%; under optimized pharmacological treatment; with resting heart rate ˂ 120 bpm; resting blood pressure ˂ 180 / 110mm Hg; previously sedentary. Exclusion Criteria: Decompensated heart failure (evidenced by ascites, lower limb edema, jugular swelling and / or pulmonary wheezing); individuals with decompensated metabolic diseases; acute coronary syndrome (ACS); survivors of sudden death; with acute myocardial infarction (AMI) and / or cardiac surgery for less than 6 months; - severe valvulopathies and / or cardiac arrhythmias; presence of asymmetric septal hypertrophic cardiomyopathy with dynamic outlet obstruction; with general contraindication criteria for performing the cardiopulmonary exercise test; - musculoskeletal disorders that limit exercise performance; with cognitive alterations that compromise the understanding of the stages and the execution of the research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz D Schaan, PhD
Organizational Affiliation
HCPorto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
HCPortoAlegre
City
Pôrto Alegre
State/Province
RS
ZIP/Postal Code
90035- 903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32334527
Citation
do Nascimento DM, Machado KC, Bock PM, Saffi MAL, Goldraich LA, Silveira AD, Clausell N, Schaan BD. Cardiopulmonary exercise capacity and quality of life of patients with heart failure undergoing a functional training program: study protocol for a randomized clinical trial. BMC Cardiovasc Disord. 2020 Apr 25;20(1):200. doi: 10.1186/s12872-020-01481-6.
Results Reference
derived

Learn more about this trial

Cardiopulmonary Capacity and Quality of Life in Patients With Chronic Heart Failure

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