Clinical trial NCT06426173: Effect of Resistance Training in Patients on the Waiting List for Heart Transplant
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Heart Transplant
Keywords: heart failure
resistance training
cardiac rehabilitation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2024-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To investigate changes in physical performance measured by Six-Minute Walk Test.
timeFrame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
measure: To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).
timeFrame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
measure: To investigate changes in respiratory muscle strength:
timeFrame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
measure: To investigate changes in peripheral muscle strength.
timeFrame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
measure: To investigate changes in quality of life:
timeFrame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
measure: Enhancing the investigation of changes in cardiac biomarker ketones
timeFrame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
measure: Enhancing the investigation of changes in cardiac biomarker brain natriuretic peptide
timeFrame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
Secondary outcomes:
measure: To investigate changes Fried's frailty phenotype
timeFrame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
measure: To investigate changes in heart rate( bpm)
timeFrame: Immediately before and after each session exercise training.(3 times per week, during 12 weeks)
measure: To investigate changes in blood pressure (mmHg)
timeFrame: Immediately before and after each session exercise training (3 times per week, during 12 weeks)
measure: To investigate changes in perceived exertion sensation:
timeFrame: Immediately before and after each session exercise training.(3 times per week, during 12 weeks)
measure: To investigate the occurrence of adverse events:Hemodynamic instability
timeFrame: In each intervention period (3 days a week for 12 weeks)
measure: To investigate the occurrence of adverse events:Arrhythmia
timeFrame: In each intervention period (3 times per week for 12 weeks)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Juliana A Nascimento, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Rafael M Ianotti, PT
role: PRINCIPAL_INVESTIGATOR
References: