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

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: Heart Failure; Heart Transplant

Treatments: Other: Standard Treatment Group; Other: Resistance Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06426173

CAAE: 77806024.4.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Resistance Training Group

Experimental group

Description:

Patients will receive the standard treatment provided by the hospital inpatient unit alongside the resistance training program.

Treatment:

Other: Resistance Training Program

Other: Standard Treatment Group

Standard Treatment Group

Active Comparator group

Description:

Patients will receive the standard treatment provided by the hospital inpatient unit.

Treatment:

Other: Standard Treatment Group