Preventive Heart Rehabilitation in patients undergoing elective Open heart surgery to prevent Complications and to improve Quality of life (Heart-ROCQ) - A randomized controlled trial<br>

Recruiting

Conditions: cardiac surgery
cardiovascular surgery
10043413

Registration Number: NL-OMON42974

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 350

Inclusion Criteria

- Age >= 18 years
- Accepted for elective coronary bypass surgery, degenerative valve disease or aortic surgery (or combined) under general anesthesia

Exclusion Criteria

• Patients accepted for transcatheter aortic valve implantation (TAVI)
• Admitted to the department of congenital heart surgery
• Aortic descendens or dissections
• 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. cardiomyopathie/morrow).
• Other treatment planned that possibly will interrupt the cardiac rehabilitation program (for example on a waiting list for a organ transplantation, preoperative endocarditis or planned chemotherapy for cancer etc.)
• Unable to read and write Dutch

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is a composite weighted endpoint of postoperative surgical<br /><br>complications, re-admissions to hospital, major adverse cardiac events and<br /><br>health related quality of life (two domains: physical functioning and physical<br /><br>problem), at three months and one year after surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary, this study is designed to evaluate the effect of the cardiac<br /><br>rehabilitation programs on:<br /><br>- Prolonged stay at the intensive care, the occurrence arrhythmias and<br /><br>rethoracotomies (Complications and events)<br /><br>- Cardiorespiratory fitness, muscle strength and functional status (Physical<br /><br>health)<br /><br>- Feelings of anxiety, depression and quality of life (Psychological health)<br /><br>- Work participation<br /><br>- Economic evaluation: health care costs, work-related costs and quality<br /><br>adjusted life years (QALYs)<br /><br>- Physical activity and smoking consumption (Lifestyle risk factors)<br /><br>- self-efficacy, illness representations (Potential mediators) </p><br>