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NCT Number: NCT06426173

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Heart Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance Training Program

Other

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

Other

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.

Primary outcomes

  1. To investigate changes in physical performance measured by Six-Minute Walk Test.

    Time frame: 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.

  2. To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).

    Time frame: 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.

  3. To investigate changes in respiratory muscle strength:

    Time frame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).

    Maximum inspiratory pressure (measured in cmH2O)

  4. To investigate changes in peripheral muscle strength.

    Time frame: The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).

    Handgrip test (measured in KgF)

  5. To investigate changes in quality of life:

    Time frame: 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.

  6. Enhancing the investigation of changes in cardiac biomarker ketones

    Time frame: 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)

  7. Enhancing the investigation of changes in cardiac biomarker brain natriuretic peptide

    Time frame: 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)

Secondary outcomes

  1. To investigate changes Fried's frailty phenotype

    Time frame: 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

  2. To investigate changes in heart rate( bpm)

    Time frame: Immediately before and after each session exercise training.(3 times per week, during 12 weeks)

  3. To investigate changes in blood pressure (mmHg)

    Time frame: Immediately before and after each session exercise training (3 times per week, during 12 weeks)

  4. To investigate changes in perceived exertion sensation:

    Time frame: 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)

  5. To investigate the occurrence of adverse events:Hemodynamic instability

    Time frame: In each intervention period (3 days a week for 12 weeks)

    Hemodynamic instability ( MAP < 60 mmHg or >120 mmHg)

  6. To investigate the occurrence of adverse events:Arrhythmia

    Time frame: In each intervention period (3 times per week for 12 weeks)

    Heart rate ( HR < 50 bpm or > 120 bpm).

Study contacts

Contact information is provided by the study sponsor or research team.

Juliana A Nascimento, PT, PhD

CONTACT

[email protected]

+55 11 30618529

Rafael M Ianotti, PT

CONTACT

[email protected]

+55 11 26615319

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
May 23, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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