Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)

NCT ID: NCT06552390

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2024-01-01

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.

Conditions

Heart Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group - HRN4HTx

Cardiac rehabilitation as previously described.

Group Type: EXPERIMENTAL

Cardiac Rehabilitation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unidade Local de Saúde de Coimbra

UNKNOWN

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: collaborator

Instituto Politécnico de Bragança

OTHER

Sponsor Role: lead

Responsible Party

André Filipe Morais Pinto Novo

Coordinator Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

André Novo, PhD.

Role: STUDY_DIRECTOR

Instituto Politécnico de Bragança

Locations

Unidade Local de Saúde de Coimbra

Coimbra, , Portugal

Countries

Portugal

References

Loureiro M, Parola V, Duarte J, Oliveira I, Antunes M, Coutinho G, Martins MM, Novo A. Cardiac Rehabilitation to Inpatient Heart Transplant-HRN4HTx Intervention Protocol. Nurs Rep. 2024 Aug 23;14(3):2084-2094. doi: 10.3390/nursrep14030155.

Reference Type: DERIVED

PMID: 39311164 (View on PubMed)

Other Identifiers

HRN4HTx_1.0

Identifier Type: -

Identifier Source: org_study_id