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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426173
• Other study ID #: CAAE: 77806024.4.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: June 2024
• Source: University of Sao Paulo General Hospital
• Contact: Juliana A Nascimento, PT, PhD
• Phone: +55 11 30618529
• Email: juliana.nascimento[@]fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2026
• Est. primary completion date: March 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Transplant

Intervention

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 from light (= 12) to moderate (= 15) on the Borg scale.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
Primary	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.	The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
Primary	To investigate changes in respiratory muscle strength:	Maximum inspiratory pressure (measured in cmH2O)	The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
Primary	To investigate changes in peripheral muscle strength.	Handgrip test (measured in KgF)	The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
Primary	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.	The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
Primary	Enhancing the investigation of changes in cardiac biomarker ketones	Ketones in exhaled air (measured in µg/L)	The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
Primary	Enhancing the investigation of changes in cardiac biomarker brain natriuretic peptide	Brain natriuretic peptide in venous blood sample (picogram per milliliter, pg/ml)	The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
Secondary	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	The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).
Secondary	To investigate changes in heart rate( bpm)		Immediately before and after each session exercise training.(3 times per week, during 12 weeks)
Secondary	To investigate changes in blood pressure (mmHg)		Immediately before and after each session exercise training (3 times per week, during 12 weeks)
Secondary	To investigate changes in perceived exertion sensation:	Borg Rating of Perceived Exertion (0-lower, up to 10- highest)	Immediately before and after each session exercise training.(3 times per week, during 12 weeks)
Secondary	To investigate the occurrence of adverse events:Hemodynamic instability	Hemodynamic instability ( MAP < 60 mmHg or >120 mmHg)	In each intervention period (3 days a week for 12 weeks)
Secondary	To investigate the occurrence of adverse events:Arrhythmia	Heart rate ( HR < 50 bpm or > 120 bpm).	In each intervention period (3 times per week for 12 weeks)