NCT06552390

Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Instituto Politécnico de Bragança · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Heart Transplantation

Interventions

Type	Name	Description
PROCEDURE	Cardiac Rehabilitation	HRN4HTx is a phase 1 rehabilitation intervention protocol for post-heart transplant focused on the physical exercise component, and an educational plan regarding risk factors and safety criteria. The intervention protocol and its assessments are implemented by the team's rehabilitation nurses, always safeguarding the protective isolation required for these patients. The physical training protocol is divided into five stages of progressive levels of intervention. The protocol was defined following FITT parameters, international recommendations, and an integrated teaching program aimed at the therapeutic regimen exercise area. The frequency of intervention sessions is 7 days a week, twice a day (average of 13 sessions per week) throughout the hospitalization. The intensity was defined according to Borg's modified scale of subjective perception of exertion (SPE), which must be maintained at less than 5.

Timeline

• Start date: 2019-01-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2024-08-14
• Last updated: 2024-08-14

Locations

1 site across 1 country: Portugal