Heart FailureNCT06426173
Effect of Resistance Training in Patients on the Waiting List for Heart Transplant
A study testing Resistance Training Program and Standard Treatment Group in people with Heart Failure and Heart Transplant, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure, Heart Transplant
- What is being tested?
- Resistance Training Program and Standard Treatment Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Jun 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Heart Transplant
- Being tested
- Resistance Training Program, Standard Treatment Group
- Keywords
- heart failure, resistance training, cardiac rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training ProgramOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training Group | Experimental | Patients will receive the standard treatment provided by the hospital inpatient unit alongside the resistance training program. Receives: 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. Receives: Other: Standard Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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 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
Measured: 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)
Measured: Immediately before and after each session exercise training.(3 times per week, during 12 weeks)
To investigate changes in blood pressure (mmHg)
Measured: Immediately before and after each session exercise training (3 times per week, during 12 weeks)
To investigate changes in perceived exertion sensation:
Borg Rating of Perceived Exertion (0-lower, up to 10- highest)
Measured: Immediately before and after each session exercise training.(3 times per week, during 12 weeks)
To investigate the occurrence of adverse events:Hemodynamic instability
Hemodynamic instability ( MAP < 60 mmHg or >120 mmHg)
Measured: In each intervention period (3 days a week for 12 weeks)
To investigate the occurrence of adverse events:Arrhythmia
Heart rate ( HR < 50 bpm or > 120 bpm).
Measured: In each intervention period (3 times per week for 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start18 Jun 2024
- Primary completion18 Mar 2025
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Rafael M. Ianotti, P.T., Ph.D., University of Sao Paulo General Hospital
- Investigators
- Juliana A Nascimento, PT, PhD, Principal investigator, University of Sao PauloRafael M Ianotti, PT, Principal investigator, Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426173
- Sponsor's protocol ID
- CAAE: 77806024.4.0000.0068
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06426173
- Acronym / sponsor ID
- CAAE: 77806024.4.0000.0068
- Conditions
- Heart Failure, Heart Transplant
- Keywords
- heart failure, resistance training, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Group | Experimental | Other: Resistance Training Program, Other: Standard Treatment GroupPatients will receive the standard treatment provided by the hospital inpatient unit alongside the resistance training program. |
| Standard Treatment Group | Active comparator | Other: Standard Treatment GroupPatients will receive the standard treatment provided by the hospital inpatient unit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Training ProgramThe 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 | Resistance Training Group |
| Standard Treatment GroupPatients 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. | Other | Resistance Training Group, Standard Treatment Group |
Primary outcome
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.
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.
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)
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)
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.
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)
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)
6 secondary outcomes
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).
To investigate changes in heart rate( bpm)
Time frame: 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)
To investigate changes in perceived exertion sensation:
Time frame: 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)
To investigate the occurrence of adverse events:Arrhythmia
Time frame: In each intervention period (3 times per week for 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juliana A Nascimento, PT, PhD principal investigator
University of Sao Paulo
Rafael M Ianotti, PT principal investigator
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training Program and Standard Treatment Group in people with Heart Failure and Heart Transplant, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliana A Nascimento, PT, PhD (+55 11 30618529, juliana.nascimento@fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.