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Completed

NCT Number: NCT03321682

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HCPortoAlegre

Pôrto Alegre, Rio Grande do Sul, 90035- 903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Training

Other

Exercises performed in circuit, using weights, elastic bands, suspension tapes, cones and on unstable surfaces.

Strength training

Other

Exercises carried out using weights and involving the main muscle groups.

Primary outcomes

  1. Cardiopulmonary Capacity

    Time frame: After 12 weeks of training.

    Cardiopulmonary capacity assessed by peak oxygen consumption in treadmill cardiopulmonary exercise test.

  2. Quality of life

    Time frame: After 12 weeks of training.

    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 outcomes

  1. Functionality

    Time frame: After 12 weeks of training.

    Functionality assessed by the Duke Activity Status Index

  2. Gait Speed

    Time frame: After 12 weeks of training.

    Gait Speed assessed by the Gait Speed Test.

  3. Palmar Grip Strength

    Time frame: After 12 weeks of training.

    Palmar grip strength evaluated by dynamometry.

  4. Maximum Inspiratory Pressure

    Time frame: After 12 weeks of training.

    Maximum inspiratory pressure evaluated by manovacuometry.

  5. Endothelial Function

    Time frame: After 12 weeks of training.

    Endothelial function evaluated by brachial artery ultrasonography.

  6. Lean Body Mass

    Time frame: After 12 weeks of training.

    Lean body mass assessed by arm muscle circumference.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Cardiopulmonary Capacity and Quality of Life in Patients With Chronic Heart Failure Submitted to Functional Training - a Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2017
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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