Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)

Not Applicable

Completed

• Conditions: Heart Transplantation
• Interventions: Procedure: Cardiac Rehabilitation

• Registration Number: NCT06552390
• Lead Sponsor: Instituto Politécnico de Bragança

Brief 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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group - HRN4HTx	Cardiac Rehabilitation	Cardiac rehabilitation as previously described.

Primary Outcome Measures

Name	Time	Method
Functional Capacity - Evaluation of the 6-minute walk test (6MWT)	At the date of discharge (mean days of hospitalization of 15 until a maximum of days 21)	6-minute walk test (6MWT), higher value means better outcome (no maximum value)
Self-Care Capacity - Evaluation of the Barthel Index	At the date of admission and at the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)	Barthel Index, from 0 to 100, higher scores means better outcome
Knowledge of Risk Factors - Evaluation of knowledge regarding alarm signs and cardiovascular risk factors	At the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)	Knowledge regarding alarm signs and cardiovascular risk factors, from 0 to 100%, higher value means better outcome

Trial Locations

Locations (1)

Unidade Local de Saúde de Coimbra; 🇵🇹 Coimbra, Portugal