An interventional study of Resistance Training Program and Standard Treatment Group in Heart Failure and Heart Transplant, sponsored by University of Sao Paulo General Hospital. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
The present longitudinal, randomized, and blinded clinical trial aims to:
The protocol will have a total duration of 12 weeks.
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:
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive the standard treatment provided by the hospital inpatient unit alongside the resistance training program.
Other: Resistance Training Program · Other: Standard Treatment Group
Patients will receive the standard treatment provided by the hospital inpatient unit.
Other: Standard Treatment Group
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 from light (≤ 12) to moderate (≤ 15) on the Borg scale.
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.
To investigate changes in physical performance measured by Six-Minute Walk Test.
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.
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).
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.
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:
Maximum inspiratory pressure (measured in cmH2O)
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.
Handgrip test (measured in KgF)
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:
Kansas City Cardiomyopathy Questionnaire-Short Version. The total score ranges from 0 (indicating a worse outcome) to 100 (indicating a better outcome) points.
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
Ketones in exhaled air (measured in μg/L)
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
Brain natriuretic peptide in venous blood sample (picogram per milliliter, pg/ml)
Time frame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
To investigate changes Fried's frailty phenotype
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
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:
Borg Rating of Perceived Exertion (0-lower, up to 10- highest)
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
Hemodynamic instability ( MAP \< 60 mmHg or \>120 mmHg)
Time frame: In each intervention period (3 days a week for 12 weeks)
To investigate the occurrence of adverse events:Arrhythmia
Heart rate ( HR \< 50 bpm or \> 120 bpm).
Time frame: In each intervention period (3 times per week for 12 weeks)
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University of Sao Paulo General Hospital