Personalized activity intervention for patients recovering from heart surgery
Personalized Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in Rehabilitation After Cardiac Operations (the PACO Trial)
NA · Kuopio University Hospital · NCT03470246
This study is testing whether a personalized activity program can help patients recovering from heart surgery feel better and recover faster compared to standard rehabilitation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 540 (estimated) |
| Ages | 30 Years to 90 Years |
| Sex | All |
| Sponsor | Kuopio University Hospital (other) |
| Locations | 1 site (Kuopio) |
| Trial ID | NCT03470246 on ClinicalTrials.gov |
What this trial studies
The PACO trial is a randomized clinical trial aimed at improving rehabilitation outcomes for patients with coronary artery disease, aortic valve stenosis, and mitral valve insufficiency undergoing elective heart surgeries. Participants will be monitored using accelerometers to assess their physical activity, sedentary behavior, and sleep patterns during the pre-operative month. After surgery, patients will be divided into intervention and control groups, with the intervention group receiving a personalized activity program alongside standard rehabilitation. The study will analyze the effectiveness of this tailored approach compared to traditional rehabilitation methods.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective coronary artery bypass grafting, aortic valve replacement, or mitral valve repair who do not have severe functional limitations.
Not a fit: Patients who experience prolonged intensive care post-surgery or have memory disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance recovery and improve overall health outcomes for patients after cardiac surgery.
How similar studies have performed: Other studies have shown promising results with personalized rehabilitation approaches, suggesting potential success for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * An eligible patient with coronary artery disease, aortic valve stenosis or mitral valve insufficiency scheduled for elective coronary artery bypass grafting, aortic valve replacement or mitral valve repair operation. * He / she does not have any severe disease or functional limitation limiting PA (other than CVD). * He / she is willing to wear a hip- and wrist-worn accelerometer. * He / she is willing and capable to use a smart phone application. Exclusion Criteria: * He / she ends up in prolonged intensive care after cardiac operation. * He / she has a memory disorder (i.e. Alzheimer's disease).
Where this trial is running
Kuopio
- Kuopio University Hospital — Kuopio, Finland (RECRUITING)
Study contacts
- Principal investigator: Jari Halonen, M.D.; Ph.D. — Heart Center, Kuopio University Hospital
- Study coordinator: Ville Vasankari, B.M. with thesis
- Email: villevas@uef.fi
- Phone: 505208148
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 Artery Disease, Aortic Valve Stenosis, Mitral Valve Insufficiency, Accelerometer, Aortic valve replacement, Aortic valve stenosis, Coronary artery bypass grafting, Coronary artery disease