Clinical trial NCT06552390: Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)
Official title: Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplantation
Keywords: Cardiac Rehabilitation
Rehabilitation
Self Care
Lead sponsor: Instituto Politécnico de Bragança
Sponsor class: OTHER
Collaborators: name: Unidade Local de Saúde de Coimbra
name: Universidade do Porto
First posted: 2024-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Capacity - Evaluation of the 6-minute walk test (6MWT)
timeFrame: At the date of discharge (mean days of hospitalization of 15 until a maximum of days 21)
measure: Self-Care Capacity - Evaluation of the Barthel Index
timeFrame: At the date of admission and at the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)
measure: Knowledge of Risk Factors - Evaluation of knowledge regarding alarm signs and cardiovascular risk factors
timeFrame: At the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Unidade Local de Saúde de Coimbra
Study officials:
affiliation: Instituto Politécnico de Bragança
name: André Novo, PhD.
role: STUDY_DIRECTOR
References: