Preventive heart rehabilitation for patients undergoing open heart surgery
Preventive Heart Rehabilitation in Patients Undergoing Elective Open Heart Surgery to Prevent Complications and to Improve Quality of Life (Heart-ROCQ) - A Prospective Randomized Open Controlled Trial, Blinded End-point (PROBE)
NA · University Medical Center Groningen · NCT02984449
This study tests if a heart rehab program before and after open heart surgery can help patients recover better and avoid complications compared to rehab only after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Groningen) |
| Trial ID | NCT02984449 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a combined pre- and postoperative cardiac rehabilitation program on patients undergoing elective open heart surgery. The program includes physical therapy, dietary counseling, psychological support, and lifestyle management, aiming to reduce postoperative complications and improve quality of life. Participants will be monitored for short-term and long-term outcomes, including surgical complications and hospital readmissions, compared to those receiving rehabilitation only after surgery.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for coronary artery bypass graft surgery, valve surgery, or aortic surgery at the University Medical Center Groningen.
Not a fit: Patients with severe comorbidities, elite athletes, or those undergoing certain other treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications and improve recovery for patients undergoing heart surgery.
How similar studies have performed: Previous studies have shown that postoperative cardiac rehabilitation improves outcomes, but the combined pre- and postoperative approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients admitted to the department of Thoracic Surgery of the UMCG for: * coronary artery bypass graft surgery * valve surgery * aortic surgery * or a combination of the surgeries mentioned above Exclusion Criteria: * Patients accepted for transcatheter aortic valve implantation (TAVI) * Patients undergoing congenital heart surgery * Aortic descendens or dissections surgery * Elite athletes * Co-morbidities that prevent participation in one or more program elements (e.g. disorders to the nervous or musculoskeletal system that limits exercise capacity, severe COPD (GOLD class 3-4), addiction to alcohol or drugs/ serious psychiatric illness) or when it is undesirable to exercise (e.g. cardiomyopathy/morrow). * Other treatment planned that possibly will interrupt the program (for example on a waiting list for an organ transplantation, preoperative endocarditis or planned chemotherapy for cancer etc.) * Unable to read, write and understand Dutch
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: MA Mariani, MD, PhD — University Medical Center Groningen
- Study coordinator: MA Mariani, MD, PhD
- Email: m.mariani@umcg.nl
- Phone: 0031503613238
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.
Conditions: Coronary, Disease, Aortic Valve Stenosis, Cardiac Surgery, cardiac rehabilitation, surgical complications, quality of life, preoperative