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Completed

NCT Number: NCT06552390

Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)

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.

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Key information

Conditions

Heart Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidade Local de Saúde de Coimbra

Coimbra, 3000, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac Rehabilitation

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.

Primary outcomes

  1. Functional Capacity - Evaluation of the 6-minute walk test (6MWT)

    Time frame: 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)

  2. Self-Care Capacity - Evaluation of the Barthel Index

    Time frame: 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

  3. Knowledge of Risk Factors - Evaluation of knowledge regarding alarm signs and cardiovascular risk factors

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Instituto Politécnico de Bragança

Other

Collaborators

  • Unidade Local de Saúde de Coimbra, EPE
  • Universidade do Porto

Registry information

Acronym: HRN4HTx

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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