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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pre+postoperative 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
干预措施: Pre+post-operative Cardiac rehabilitation (Behavioral)
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.
干预措施: Postoperative Cardiac rehabilitation (Behavioral)
结局指标
主要结局
a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
研究者
M.A. Mariani
Prof. Dr. M.A. Mariani
University Medical Center Groningen