## Protocol Section
### Identification Module
**NCT ID:** NCT06426173

**Brief Title:** Effect of Resistance Training in Patients on the Waiting List for Heart Transplant

**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

#### Organization Study ID Info
**ID:** CAAE: 77806024.4.0000.0068
#### Organization
**Class:** OTHER
**Full Name:** University of Sao Paulo General Hospital
### Status Module
#### Completion Date
**Date:** 2026-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Conselho Nacional de Desenvolvimento Científico e Tecnológico

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Sao Paulo General Hospital

#### Responsible Party

**Investigator Affiliation:** University of Sao Paulo General Hospital

**Investigator Full Name:** Rafael M. Ianotti, PT

**Investigator Title:** Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Heart Failure

- Heart Transplant

**Keywords:**

- heart failure

- resistance training

- cardiac rehabilitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized controlled trial

##### Masking Info

**Masking:** SINGLE

**Masking Description:** The researcher responsible for conducting the functional assessment will be blinded to the randomization and allocation groups.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Resistance Training Program

- Other: Standard Treatment Group

**Label:** Resistance Training Group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Standard Treatment Group

**Label:** Standard Treatment Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Resistance Training Group

**Description:** 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.

**Name:** Resistance Training Program

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Resistance Training Group

- Standard Treatment Group

**Description:** 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.

**Name:** Standard Treatment Group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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).

**Description:** 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.

**Measure:** 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).

**Description:** Maximum inspiratory pressure (measured in cmH2O)

**Measure:** 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).

**Description:** Handgrip test (measured in KgF)

**Measure:** 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).

**Description:** Kansas City Cardiomyopathy Questionnaire-Short Version. The total score ranges from 0 (indicating a worse outcome) to 100 (indicating a better outcome) points.

**Measure:** 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).

**Description:** Ketones in exhaled air (measured in μg/L)

**Measure:** 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).

**Description:** Brain natriuretic peptide in venous blood sample (picogram per milliliter, pg/ml)

**Measure:** 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).

#### Secondary Outcomes

**Description:** 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

**Measure:** 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).

**Measure:** To investigate changes in heart rate( bpm)

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

**Measure:** To investigate changes in blood pressure (mmHg)

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

**Description:** Borg Rating of Perceived Exertion (0-lower, up to 10- highest)

**Measure:** To investigate changes in perceived exertion sensation:

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

**Description:** Hemodynamic instability ( MAP \< 60 mmHg or \>120 mmHg)

**Measure:** To investigate the occurrence of adverse events:Hemodynamic instability

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

**Description:** Heart rate ( HR \< 50 bpm or \> 120 bpm).

**Measure:** To investigate the occurrence of adverse events:Arrhythmia

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

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** juliana.nascimento@fm.usp.br

**Name:** Juliana A Nascimento, PT, PhD

**Phone:** +55 11 30618529

**Role:** CONTACT

**Contact 2:**

**Email:** rafael.ianotti@hc.fm.usp.br

**Name:** Rafael M Ianotti, PT

**Phone:** +55 11 26615319

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sao Paulo

**Country:** Brazil

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

**Zip:** 05403-000

#### Overall Officials

**Official 1:**

**Affiliation:** University of Sao Paulo

**Name:** Juliana A Nascimento, PT, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

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

**Name:** Rafael M Ianotti, PT

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-31
