Preventive Heart Rehabilitation to Prevent Complications in Patients Undergoing Elective Open Heart Surgery

Aortic Valve Stenosis Clinical Trial

— Heart-ROCQ  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02984449
• Other study ID #: METc: 2016/464 UMCG: 201600576
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2019
• Source: University Medical Center Groningen
• Contact: MA Mariani, MD, PhD
• Phone: 0031503613238
• Email: m.mariani[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiac Surgery
• Coronary (Artery); Disease
• Coronary Artery Disease
• Coronary Disease

Intervention

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).
• 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).

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Illness perception (IPQ-R),		Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Other	Cardiac self-efficacy scale (CSA)		Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Primary	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	Atrial fibrillation		up to one year post-surgery
Secondary	prolonged stay at the intensive care unit		up to one year post-surgery
Secondary	re-thoracotomy		up to one year post-surgery
Secondary	re-admissions to intensive care unit		up to one year post-surgery
Secondary	re-admissions to hospital		up to one year post-surgery
Secondary	All-cause mortality		up to five year post-surgery
Secondary	six minutes walking test		Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Secondary	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
Secondary	functional status (KATZ)		Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Secondary	Quality of life (Rand-36-v2)		Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Secondary	Depression (PHQ-9)		Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Secondary	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
Secondary	iMTA Productivity Cost Questionnaire (PCQ)		Baseline, 3-4, 7-8 and 12 months post-surgery
Secondary	iMTA Medical Cost Questionnaire (MCQ)		Baseline, 3-4, 7-8 and 12 months post-surgery
Secondary	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