Effect of Resistance Training in Patients on the Waiting List for Heart Transplant
- Conditions
- Heart TransplantHeart Failure
- Interventions
- Other: Standard Treatment GroupOther: Resistance Training Program
- Registration Number
- NCT06426173
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Treatment Group Standard Treatment Group Patients will receive the standard treatment provided by the hospital inpatient unit. Resistance Training Group Resistance Training Program Patients will receive the standard treatment provided by the hospital inpatient unit alongside the resistance training program. Resistance Training Group Standard Treatment Group Patients will receive the standard treatment provided by the hospital inpatient unit alongside the resistance training program.
- Primary Outcome Measures
Name Time Method To investigate changes in peripheral muscle strength. The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). Handgrip test (measured in KgF)
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB). The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). The SPPB consists of three additional tests assessing balance, mobility, and strength. Each test is scored from 0 (indicating a worse outcome) to 4 (indicating a better outcome) points. At the completion of all tests, the total score ranges from 0 to 12 points.
To investigate changes in respiratory muscle strength: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). Maximum inspiratory pressure (measured in cmH2O)
Enhancing the investigation of changes in cardiac biomarker brain natriuretic peptide The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). Brain natriuretic peptide in venous blood sample (picogram per milliliter, pg/ml)
Enhancing the investigation of changes in cardiac biomarker ketones The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). Ketones in exhaled air (measured in μg/L)
To investigate changes in physical performance measured by Six-Minute Walk Test. The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible.
To investigate changes in quality of life: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). Kansas City Cardiomyopathy Questionnaire-Short Version. The total score ranges from 0 (indicating a worse outcome) to 100 (indicating a better outcome) points.
- Secondary Outcome Measures
Name Time Method To investigate changes Fried's frailty phenotype The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). The Fried's frailty phenotype scale ranges from 0 to 5 points, where: 0 points denote non-frailty, up to 2 points denote pre-frailty, and ≥3 points denote frailty
To investigate the occurrence of adverse events:Arrhythmia In each intervention period (3 times per week for 12 weeks) Heart rate ( HR \< 50 bpm or \> 120 bpm).
To investigate changes in blood pressure (mmHg) Immediately before and after each session exercise training (3 times per week, during 12 weeks) To investigate changes in perceived exertion sensation: Immediately before and after each session exercise training.(3 times per week, during 12 weeks) Borg Rating of Perceived Exertion (0-lower, up to 10- highest)
To investigate changes in heart rate( bpm) Immediately before and after each session exercise training.(3 times per week, during 12 weeks) To investigate the occurrence of adverse events:Hemodynamic instability In each intervention period (3 days a week for 12 weeks) Hemodynamic instability ( MAP \< 60 mmHg or \>120 mmHg)
Trial Locations
- Locations (1)
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷Sao Paulo, Brazil