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

NCT03321682 | Completed

• 1 other identifier: 69314017.8.0000.5327
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Cardiopulmonary Capacity; Quality of Life; Functional Capacity; Functional Training

Outcome Measures

Primary Outcomes (2)

• Cardiopulmonary Capacity

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

  After 12 weeks of training.

• 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.

  After 12 weeks of training.

Secondary Outcomes (6)

• Functionality

  After 12 weeks of training.

• Gait Speed

  After 12 weeks of training.

• Palmar Grip Strength

  After 12 weeks of training.

• Maximum Inspiratory Pressure

  After 12 weeks of training.

• Endothelial Function

  After 12 weeks of training.

Study Arms (2)

Functional Training

EXPERIMENTAL

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.

Other: Functional Training

Strength Training

ACTIVE COMPARATOR

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

Other: Strength Training

Interventions

Functional Training OTHER

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

Functional Training

Strength Training OTHER

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

Strength Training

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

HCPortoAlegre

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

Location

Related Publications (2)

• do Nascimento DM, Machado KC, Bock PM, Saffi MAL, Goldraich LA, Silveira AD, Clausell N, Schaan BD. Functional training improves peak oxygen consumption and quality of life of individuals with heart failure: a randomized clinical trial. BMC Cardiovasc Disord. 2023 Jul 29;23(1):381. doi: 10.1186/s12872-023-03404-7.

  PMID: 37516830 DERIVED

• 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.

  PMID: 32334527 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Beatriz D Schaan, PhD

  HCPorto Alegre

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 26, 2017
• Study Start: March 6, 2017
• Primary Completion: September 1, 2020
• Study Completion: November 30, 2020
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

BR (1)