Exercise and heart transplant rehabilitation
Exercise aNd hEArt Transplant
This study tests two different exercise programs to see which one helps people recover better after a heart transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT05824364 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of two different exercise training schemes for patients who have recently undergone heart transplantation. It involves a randomized pilot study with 40 participants, comparing a standard cardiac rehabilitation program to a combination of on-site rehabilitation followed by telerehabilitation. The study will assess both cardiometabolic and clinical outcomes, including acute rejection and hospitalization rates, over a minimum follow-up period of six months. Additionally, the trial will utilize a rehabilomic approach to analyze circulating molecules that may indicate rehabilitation outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients who have recently undergone heart transplantation and are eligible for cardiac rehabilitation.
Not a fit: Patients unable to provide informed consent or those not admitted to on-site cardiac rehabilitation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery and long-term health outcomes for heart transplant patients through improved rehabilitation strategies.
How similar studies have performed: While the approach of combining on-site rehabilitation with telerehabilitation is innovative, similar studies have shown promise in improving outcomes for cardiac patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All the patients admitted in the on-site CR after HTx Exclusion Criteria: * unable to sign informed consent
Where this trial is running
Milan, Milan
- IRCCS Fondazione Don Gnocchi, Milan — Milan, Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Nuccia Morici, MD — IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
- Study coordinator: Nuccia Morici, MD
- Email: nmorici@dongnocchi.it
- Phone: 00390240308122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.