Preventive Heart Rehabilitation to Prevent Complications in Patients Undergoing Elective Open Heart Surgery
- Conditions
- Aortic Valve StenosisCardiac SurgeryCoronary (Artery); Disease
- Interventions
- Behavioral: Postoperative Cardiac rehabilitationBehavioral: Pre+post-operative Cardiac rehabilitation
- Registration Number
- NCT02984449
- Lead Sponsor
- University Medical Center Groningen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Postoperative Cardiac rehabilitation Postoperative Cardiac rehabilitation 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. Pre+postoperative Cardiac rehabilitation Pre+post-operative Cardiac rehabilitation 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 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)
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands