Aortic Valve Stenosis, Cardiac Surgery, Coronary (Artery); Disease
Conditions
Keywords
cardiac rehabilitation, surgical complications, quality of life, preoperative, cardiac surgery
Brief summary
Rationale: Patients undergoing cardiac surgery are at risk of developing perioperative complications and major adverse cardiac events, mainly related to both their preoperative status and type of surgical procedure. Postoperative exercise based cardiac rehabilitation (CR) is an effective therapy to prolong survival and improve quality of life. However, little is known about the effect on post-operative complications, quality of life and return to work of a combined pre- and post-operative CR program encompassing physical therapy, dietary counseling, psychological support and life style management compared to a CR program, which is provided only after cardiac surgery. Objective: to determine whether a pre- and postoperative (PRE+POST) CR program improves the short (up to three months) and long term outcomes (up to one year) of the cardiac surgery (i.e. reduction in postoperative surgical complications, readmissions to hospital and major adverse cardiac events in conjunction with improvements in the physical component of health related quality of life), when compared to postoperative CR only (POST). Study design: A Prospective Randomized Open controlled trial, Blinded End-point. Patients are randomized between two standard care CR programs. One group will start a the POST CR program after surgery. The other group will be randomized to a combined PRE+POST CR program. Study population: Patients (age \> 18 years) admitted for elective coronary bypass surgery, valve surgery and/or aortic surgery Main study parameters/endpoints: 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. Endpoints are determined by an independent endpoint committee, blinded to the group allocation. Secondary, the study focuses on physical health (cardiorespiratory fitness, muscle strength and functional status), psychological health (feelings of anxiety and depression), work participation, economics, lifestyle risk factors (physical activity and smoking behavior), self-efficacy and illness representations.
Interventions
BEHAVIORALPre+post-operative Cardiac rehabilitation
CR has the aim to influence favorably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions (BACPR, 2012).
BEHAVIORALPostoperative Cardiac rehabilitation
CR has the aim to influence favorably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions (BACPR, 2012).
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Double blinding (researcher and participants) is not possible because of logistic reasons. However, the primary endpoint is evaluated by an independent end-point committee, blinded for group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events | Up to one year post-surgery | Each event, complication or worsening in functional status are considered as a score of 1 to 3 points. These points are summed to calculate the total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation | up to one year post-surgery | — |
| prolonged stay at the intensive care unit | up to one year post-surgery | — |
| re-thoracotomy | up to one year post-surgery | — |
| re-admissions to intensive care unit | up to one year post-surgery | — |
| re-admissions to hospital | up to one year post-surgery | — |
| All-cause mortality | up to five year post-surgery | — |
| six minutes walking test | Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery | — |
| muscle strength | Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery | This will include grip strength and knee extension |
| iMTA Medical Cost Questionnaire (MCQ) | Baseline, 3-4, 7-8 and 12 months post-surgery | — |
| Lifestyle risk factors | Baseline, 3-4 months and one year post-surgery | Physical activity is assessed using the Sensewear GECKO mini-armband (SWA) and the long version (27 questions) of the International Physical Activity Questionnaire (iPAQ) |
| functional status (KATZ) | Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery | — |
| Quality of life (Rand-36-v2) | Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery | — |
| Depression (PHQ-9) | Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery | — |
| Anxiety (GAD) | Baseline, one day before surgery, 4-7 days, 3-4 months and one year after surgery | Depression (PHQ-9), anxiety (GAD), Quality of life (Rand-36-v2) |
| iMTA Productivity Cost Questionnaire (PCQ) | Baseline, 3-4, 7-8 and 12 months post-surgery | — |
Other
| Measure | Time frame |
|---|---|
| Illness perception (IPQ-R), | Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery |
| Cardiac self-efficacy scale (CSA) | Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery |
Countries
Netherlands
Contacts
Primary ContactMA Mariani, MD, PhD
Backup ContactJ Hartog, MSc
Outcome results
None listed