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

NCT02984449 | Unknown DMC

• 1 other identifier: METc: 2016/464 UMCG: 201600576
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cardiac rehabilitation; surgical complications; quality of life; preoperative; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Other Outcomes (2)

• 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

Study Arms (2)

Pre+postoperative Cardiac rehabilitation

EXPERIMENTAL

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

Postoperative Cardiac rehabilitation

ACTIVE COMPARATOR

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

Interventions

Pre+post-operative Cardiac rehabilitation BEHAVIORAL

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).

Also known as: Exercise, physical fitness, nutrition, psychological support

Pre+postoperative Cardiac rehabilitation

Postoperative Cardiac rehabilitation BEHAVIORAL

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).

Also known as: Exercise, physical fitness, nutrition, psychological support

Postoperative Cardiac rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 31537574 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Stenosis

Interventions

Exercise; Physical Fitness; Nutritional Status

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography

Study Officials

• MA Mariani, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MA Mariani, MD, PhD

CONTACT

0031503613238; m.mariani@umcg.nl

J Hartog, MSc

CONTACT

0031503617527; j.hartog@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. M.A. Mariani

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 7, 2016
• Study Start: May 3, 2017
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2025
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)