Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)

Instituto Politécnico de Bragança

Status: Completed

Conditions: Heart Transplantation

Treatments: Procedure: Cardiac Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06552390

HRN4HTx_1.0

Details and patient eligibility

About

To evaluate the safety and efficacy of the phase 1 cardiac rehabilitation protocol(HRN4HTx) in heart transplant patients, focusing on self-care capacity and functionalrecovery.

Full description

Type of study: Descriptive and Interventional Study

• Location: Centro Hospitalar e Universitário de Coimbra, Cardiothoracic Surgery Unit

Study Population:

• Inclusion Criteria: Heart transplant patients, over 18 years of age, capable of providing informed consent.
• Exclusion Criteria: Rejection 2R, inability to understand due to cognitive impairment, external ventricular assistance, infectious processes with hemodynamic changes.

Intervention:

The HRN4HTx protocol was implemented during hospitalization, divided into five progressive stages according to FITT parameters and international recommendations. Interventions included respiratory exercises, calisthenics exercises, balance training, resistance exercises for upper and lower limbs, and walking.

Adverse Event Monitoring:

Adverse events (AEs) and serious adverse events (SAEs) were monitored according to Good Clinical Practices. Examples of monitored events include arrhythmias and significant changes in blood pressure.

Outcomes Measured:

• Self-Care Capacity: Barthel Index measured at admission and discharge.
• Functional Capacity: 6-minute walk test (6MWT) conducted at discharge.
• Knowledge of Risk Factors: Evaluation of knowledge regarding alarm signs and cardiovascular risk factors at discharge.

Ethical Approval:

This study was approved by the Ethics Committee of the Centro Hospitalar e Universitáriode Coimbra (Protocol No. OBS.SF.111/2021). All participants provided written informed consent prior to participation.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heart transplant patients, over 18 years of age, capable of providing informedconsent.

Exclusion criteria

• Rejection 2R
• Inability to understand due to cognitive impairment
• External ventricular assistance
• Infectious processes with hemodynamic changes

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intervention Group - HRN4HTx

Experimental group

Description:

Cardiac rehabilitation as previously described.

Treatment:

Procedure: Cardiac Rehabilitation