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

NCT06426173 | Recruiting

• 1 other identifier: CAAE: 77806024.4.0000.0068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Heart Transplant

Keywords

heart failure; resistance training; cardiac rehabilitation

Outcome Measures

Primary Outcomes (7)

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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 Outcomes (6)

• To investigate changes Fried's frailty phenotype

  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)

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

• To investigate changes in blood pressure (mmHg)

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

• To investigate changes in perceived exertion sensation:

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

• To investigate the occurrence of adverse events:Hemodynamic instability

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

Study Arms (2)

Resistance Training Group

EXPERIMENTAL

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

Other: Resistance Training Program; Other: Standard Treatment Group

Standard Treatment Group

ACTIVE COMPARATOR

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

Other: Standard Treatment Group

Interventions

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.

Resistance Training Group

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.

Resistance Training Group; Standard Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

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

São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Juliana A Nascimento, PT, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Rafael M Ianotti, PT

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana A Nascimento, PT, PhD

CONTACT

+55 11 30618529; juliana.nascimento@fm.usp.br

Rafael M Ianotti, PT

CONTACT

+55 11 26615319; rafael.ianotti@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for conducting the functional assessment will be blinded to the randomization and allocation groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 23, 2024
• Study Start: June 18, 2024
• Primary Completion: March 18, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

BR (1)