Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)

NCT06552390 | Completed

• 1 other identifier: HRN4HTx_1.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplantation

Keywords

Cardiac Rehabilitation; Rehabilitation; Self Care

Outcome Measures

Primary Outcomes (3)

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

  6-minute walk test (6MWT), higher value means better outcome (no maximum value)

  At the date of discharge (mean days of hospitalization of 15 until a maximum of days 21)

• Self-Care Capacity - Evaluation of the Barthel Index

  Barthel Index, from 0 to 100, higher scores means better outcome

  At the date of admission and at the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)

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

  Knowledge regarding alarm signs and cardiovascular risk factors, from 0 to 100%, higher value means better outcome

  At the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)

Study Arms (1)

Intervention Group - HRN4HTx

EXPERIMENTAL

Cardiac rehabilitation as previously described.

Procedure: Cardiac Rehabilitation

Interventions

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.

Intervention Group - HRN4HTx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart transplant patients, over 18 years of age, capable of providing informedconsent.

You may not qualify if:

• Rejection 2R
• Inability to understand due to cognitive impairment
• External ventricular assistance
• Infectious processes with hemodynamic changes

Sponsors & Collaborators

• Instituto Politécnico de Bragança: lead
• Unidade Local de Saúde de Coimbra: collaborator
• Universidade do Porto: collaborator

Study Sites (1)

Unidade Local de Saúde de Coimbra

Coimbra, 3000, Portugal

Location

Related Publications (1)

• 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.

  PMID: 39311164 DERIVED

MeSH Terms

Interventions

Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• André Novo, PhD.

  Instituto Politécnico de Bragança

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator Professor

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 14, 2024
• Study Start: January 1, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)