An interventional study of Cardiac Rehabilitation in Heart Transplantation, sponsored by Instituto Politécnico de Bragança. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Instituto Politécnico de Bragança · Not applicable, Interventional, and Treatment
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
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.
Instituto Politécnico de Bragança is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cardiac rehabilitation as previously described.
Procedure: Cardiac Rehabilitation
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.
Functional Capacity - Evaluation of the 6-minute walk test (6MWT)
6-minute walk test (6MWT), higher value means better outcome (no maximum value)
Time frame: 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
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)
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
Time frame: At the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Instituto Politécnico de Bragança