Preventive Heart Rehabilitation to Prevent Complications in Patients Undergoing Elective Open Heart Surgery (Heart-ROCQ)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Cardiac Surgery; Coronary (Artery); Disease
• Intervention / Treatment: Behavioral: Pre+post-operative Cardiac rehabilitation; Behavioral: Postoperative Cardiac rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MA Mariani, MD, PhD; Phone Number: 0031503613238; Email: m.mariani@umcg.nl
• Study Contact Backup: Name: J Hartog, MSc; Phone Number: 0031503617527; Email: j.hartog@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: J. Hartog, MSc; Phone Number: 0031503617527; Email: j.hartog@umcg.nl
    • Contact: M.A. Mariani, PhD, MSc; Phone Number: 0031503613238; Email: m.mariani@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Pre+post-operative Cardiac rehabilitation; 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).; Other Names: Exercise; nutrition; physical fitness; psychological support
Active Comparator: 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.	Behavioral: Postoperative Cardiac rehabilitation; 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).; Other Names: Exercise; nutrition; physical fitness; psychological support

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: MA Mariani, MD, PhD, University Medical Center Groningen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: cardiac surgery; quality of life; surgical complications; preoperative; cardiac rehabilitation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Artery Disease; Coronary Disease; Aortic Valve Stenosis
• Other Study ID Numbers: METc: 2016/464 UMCG: 201600576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No