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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre+postoperative Cardiac rehabilitation | Experimental | 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 |
|
| Postoperative Cardiac rehabilitation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre+post-operative Cardiac rehabilitation | Behavioral | 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). |
| 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 |
| 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 |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MA Mariani, MD, PhD | Contact | 0031503613238 | m.mariani@umcg.nl | |
| J Hartog, MSc | Contact | 0031503617527 | j.hartog@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| MA Mariani, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31537574 | Derived | Hartog J, Blokzijl F, Dijkstra S, DeJongste MJL, Reneman MF, Dieperink W, van der Horst ICC, Fleer J, van der Woude LHV, van der Harst P, Mariani MA. Heart Rehabilitation in patients awaiting Open heart surgery targeting to prevent Complications and to improve Quality of life (Heart-ROCQ): study protocol for a prospective, randomised, open, blinded endpoint (PROBE) trial. BMJ Open. 2019 Sep 18;9(9):e031738. doi: 10.1136/bmjopen-2019-031738. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2016 |
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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.
|
| Postoperative Cardiac rehabilitation | Behavioral | 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). |
|
|
| 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 |
| Apr 26, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D010809 | Physical Fitness |
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006262 | Health |
| D011154 | Population Characteristics |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
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