Effect of Resistance Training in Patients on the Waiting List for Heart Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resistance Training Program, Standard Treatment Group.
- Who it may be relevant to
- Registry conditions: Heart Failure, Heart Transplant. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Other 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 - Other 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.
Primary outcome measures
- To investigate changes in physical performance measured by Six-Minute Walk Test. [Time frame: 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). [Time frame: 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: [Time frame: 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. [Time frame: 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: [Time frame: 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 [Time frame: 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 [Time frame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).]
Secondary outcome measures (6)
- To investigate changes Fried's frailty phenotype [Time frame: 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) [Time frame: Immediately before and after each session exercise training.(3 times per week, during 12 weeks)]
- To investigate changes in blood pressure (mmHg) [Time frame: Immediately before and after each session exercise training (3 times per week, during 12 weeks)]
- To investigate changes in perceived exertion sensation: [Time frame: Immediately before and after each session exercise training.(3 times per week, during 12 weeks)]
- To investigate the occurrence of adverse events:Hemodynamic instability [Time frame: In each intervention period (3 days a week for 12 weeks)]
- To investigate the occurrence of adverse events:Arrhythmia [Time frame: In each intervention period (3 times per week for 12 weeks)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de S — São Paulo
Identifiers
NCT: NCT06426173 · CAAE: 77806024.4.0000.0068