Effect of Resistance Training in Patients on the Waiting List for Heart Transplant

Официальное название

Effect of Resistance Training on Functional Capacity, Quality of Life and Cardiac Biomarkers in Patients on the Waiting List for Heart Transplant: a Randomized and Controlled Clinical Trial

Обзор

The present longitudinal, randomized, and blinded clinical trial aims to: * Evaluate the effects of resistance training on the functional capacity, quality of life, and cardiac biomarkers of hospitalized patients with heart failure (HF) on the waiting list for heart transplantation (HTx). * Evaluate the associations between Fried's frailty classification and functional capacity responses to resistance training. The protocol will have a total duration of 12 weeks.

Подробное описание

Heart failure (HF) presents a significant challenge to contemporary healthcare systems. As HF progresses, heart transplantation (HTx) becomes the primary treatment option to enhance survival rates. Patients awaiting HTx often endure extended hospitalizations and rely on continuous inotropic support. This scenario exacerbates bed rest and potentially worsening functional capacity. Resistance training has shown promise in mitigating the detrimental effects of immobility, however, limited research has explored its impact on HF patients on the HTx waiting list.

Objectives:

* To evaluate the effects of resistance training on functional capacity, quality of life, and cardiac biomarkers in hospitalized patients with HF on the HTx waiting list. * To assess the associations between Fried's frailty phenotype and functional capacity responses to resistance training, hemodynamic behavior during the protocol, and the incidence of adverse events during the protocol implementation.

Methods:

A total of 50 patients hospitalized on the HTx waiting list will be recruited for this study. Participants will be randomly assigned to one of two groups: the resistance training group (TG) and the control group (CG). Assessments will occur at three time points: baseline (T0), at 6 weeks (T1), and at 12 weeks (T2) of resistance training. Clinical parameters will be evaluated, including the six-minute walk test and the Short Physical Performance Battery. Peripheral muscle strength will be measured using a dynamometer, and inspiratory muscle strength will be assessed through maximum inspiratory pressure. Quality of life will be evaluated using the Kansas City Cardiomyopathy Questionnaire-12. Additionally, cardiac biomarkers, such as exhaled air ketone and brain natriuretic peptide levels in venous blood samples, will be analyzed.

Вмешательства

• Другое Resistance Training Program
  The resistance training program will be individualized and divided into four stages of increasing complexity. It will be conducted for approximately 40 minutes per day, three times a week, for 12 weeks, under supervision. Each patient will begin the program at the stage corresponding to their functional capacity. The resistance load will be set at 50% of the maximum resistance (1RM) obtained in the initial assessment. Throughout all stages of the exercise program, the target intensity will range
• Другое Standard Treatment Group
  Patients will receive the standard treatment provided by the hospital inpatient unit, which includes guidance on reducing sedentary time, encouragement to walk, and performance of active and breathing exercises when necessary.

Первичные конечные точки

• To investigate changes in physical performance measured by Six-Minute Walk Test. [Срок оценки: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).]
• To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB). [Срок оценки: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).]
• To investigate changes in respiratory muscle strength: [Срок оценки: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).]
• To investigate changes in peripheral muscle strength. [Срок оценки: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).]
• To investigate changes in quality of life: [Срок оценки: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).]
• Enhancing the investigation of changes in cardiac biomarker ketones [Срок оценки: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).]
• Enhancing the investigation of changes in cardiac biomarker brain natriuretic peptide [Срок оценки: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).]

Вторичные конечные точки (6)

• To investigate changes Fried's frailty phenotype [Срок оценки: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).]
• To investigate changes in heart rate( bpm) [Срок оценки: Immediately before and after each session exercise training.(3 times per week, during 12 weeks)]
• To investigate changes in blood pressure (mmHg) [Срок оценки: Immediately before and after each session exercise training (3 times per week, during 12 weeks)]
• To investigate changes in perceived exertion sensation: [Срок оценки: Immediately before and after each session exercise training.(3 times per week, during 12 weeks)]
• To investigate the occurrence of adverse events:Hemodynamic instability [Срок оценки: In each intervention period (3 days a week for 12 weeks)]
• To investigate the occurrence of adverse events:Arrhythmia [Срок оценки: In each intervention period (3 times per week for 12 weeks)]

Критерии участия

Критерии включения

• patients included in heart transplant list ≤1 month
• hemodynamically stable in the last 48 hours defined as mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg and - Heart rate (HR) ≥ 60 bpm and ≤ 120 mmHg.
• dobutamine dose ≤ 10 mcg/kg/min

Критерии исключения

• heart failure of arrhythmogenic and/or restrictive etiology
• presence of uncontrolled acute arrhythmias
• cognitive, orthopedic, or neuromotor changes that prevent functional tests from being carried out

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de S — São Paulo

Идентификаторы

NCT: NCT06426173 · CAAE: 77806024.4.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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