Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Unidade Local de Saúde de Coimbra, EPE | OTHER |
| Universidade do Porto | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Type of study: Descriptive and Interventional Study
- Location: Centro Hospitalar e Universitário de Coimbra, Cardiothoracic Surgery Unit
Study Population:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group - HRN4HTx | Experimental | Cardiac rehabilitation as previously described. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| André Novo, PhD. | Instituto Politécnico de Bragança | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade Local de Saúde de Coimbra | Coimbra | 3000 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39311164 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |