Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552390
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Cardiac Rehabilitation for Inpatient Heart Transplant HRN4HTx
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cardiac Rehabilitation for Inpatient Heart Transplant HRN4HTx
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HRN4HTx
Brief Summary:
To evaluate the safety and efficacy of the phase 1 cardiac rehabilitation protocolHRN4HTx 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 OBSSF1112021 All participants provided written informed consent prior to participation
- 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 OBSSF1112021 All participants provided written informed consent prior to participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None