Preventive Heart Rehabilitation to Prevent Complications in Patients Undergoing Elective Open Heart Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Coronary (Artery); Disease, Aortic Valve Stenosis, Cardiac Surgery

Intervention / Treatment
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* Behavioral: Pre+post-operative Cardiac rehabilitation
* Behavioral: Postoperative Cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre+postoperative Cardiac rehabilitation<br>receive a cardiac rehabilitation program consisting of three phases. 1) A preoperative optimization phase (3x p/wk, 4-6 weeks, before surgery), 2) a postoperative in-patient phase (15 to 18 days in rehabilitation center, weekend at home) and, 3) an outpatient patient clinical rehabilitation phase (2x p/wk, 4 weeks). During each phase, patients will visit a physical therapist (group sessions of inspiratory muscle training (IMT), strength training, aerobic cycling and breath, cough and relaxation sessions), a dietician and a psychologist to optimize general health and receive advice on lifestyle, anxiety and stress management. Two additional components are coaching to stop smoking | Behavioral: Pre+post-operative Cardiac rehabilitation<br>* 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).<br>* Other names: psychological support;|
| Active Comparator: Postoperative Cardiac rehabilitation<br>Patients who are randomized to the POST group receive an out-patient cardiac rehabilitation program after surgery. In general, this program starts three to six weeks after discharge (phase ǀǀ) and patients always start with an exercise program, which is supervised by a physical therapist for about six weeks (twice a week). On indication support of psychological and/or dietary consult is added. | Behavioral: Postoperative Cardiac rehabilitation<br>* 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).<br>* Other names: psychological support;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events | 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. | Up to one year post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | This will include grip strength and knee extension | Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery | 
| 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) | Depression (PHQ-9), anxiety (GAD), Quality of life (Rand-36-v2) | Baseline, one day before surgery, 4-7 days, 3-4 months and one year after surgery | 
| iMTA Productivity Cost Questionnaire (PCQ) |  | Baseline, 3-4, 7-8 and 12 months post-surgery | 
| iMTA Medical Cost Questionnaire (MCQ) |  | Baseline, 3-4, 7-8 and 12 months post-surgery | 
| Lifestyle risk factors | Physical activity is assessed using the Sensewear GECKO mini-armband (SWA) and the long version (27 questions) of the International Physical Activity Questionnaire (iPAQ) | Baseline, 3-4 months and one year post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, surgical complications, quality of life, preoperative, cardiac surgery