Clinical trial NCT02984449: Preventive Heart Rehabilitation to Prevent Complications in Patients Undergoing Elective Open Heart Surgery
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary (Artery); Disease
Aortic Valve Stenosis
Cardiac Surgery
Keywords: cardiac rehabilitation
surgical complications
quality of life
preoperative
cardiac surgery
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events
timeFrame: Up to one year post-surgery
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: up to one year post-surgery
measure: prolonged stay at the intensive care unit
timeFrame: up to one year post-surgery
measure: re-thoracotomy
timeFrame: up to one year post-surgery
measure: re-admissions to intensive care unit
timeFrame: up to one year post-surgery
measure: re-admissions to hospital
timeFrame: up to one year post-surgery
measure: All-cause mortality
timeFrame: up to five year post-surgery
measure: six minutes walking test
timeFrame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: muscle strength
timeFrame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: functional status (KATZ)
timeFrame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: Quality of life (Rand-36-v2)
timeFrame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: Depression (PHQ-9)
timeFrame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: Anxiety (GAD)
timeFrame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year after surgery
measure: iMTA Productivity Cost Questionnaire (PCQ)
timeFrame: Baseline, 3-4, 7-8 and 12 months post-surgery
measure: iMTA Medical Cost Questionnaire (MCQ)
timeFrame: Baseline, 3-4, 7-8 and 12 months post-surgery
measure: Lifestyle risk factors
timeFrame: Baseline, 3-4 months and one year post-surgery
Other outcomes:
measure: Illness perception (IPQ-R),
timeFrame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: Cardiac self-efficacy scale (CSA)
timeFrame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: MA Mariani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.