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

June 18, 2024 updated by: Rafael M. Ianotti, PT, University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Recruiting
        • Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance Training Group
Patients will receive the standard treatment provided by the hospital inpatient unit alongside the resistance training program.
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.
Other: 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.
Active Comparator: Standard Treatment Group
Patients will receive the standard treatment provided by the hospital inpatient unit.
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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)
Immediately before and after each session exercise training (3 times per week, during 12 weeks)
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)
Immediately before and after each session exercise training.(3 times per week, during 12 weeks)
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)
In each intervention period (3 days a week for 12 weeks)
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).
In each intervention period (3 times per week for 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Rafael M Ianotti, PT, Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Principal Investigator: Juliana A Nascimento, PT, PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2024

Primary Completion (Estimated)

March 18, 2025

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 77806024.4.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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