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

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 - Heart-ROCQ

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42974

Enrollment

350

Registered

2017-01-17

Start date

2017-05-15

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac surgery cardiovascular surgery

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results