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

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Brief Title

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)

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.

Study Type

Interventional

Primary Outcome

a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events

Secondary Outcome

 Atrial fibrillation

Condition

Coronary (Artery); Disease

Intervention

Pre+post-operative Cardiac rehabilitation

Study Arms / Comparison Groups

 Pre+postoperative Cardiac rehabilitation
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Behavioral

Estimated Enrollment

350

Start Date

May 3, 2017

Completion Date

August 31, 2025

Primary Completion Date

August 31, 2021

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

MA Mariani, MD, PhD, 0031503613238, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT02984449

Organization ID

METc: 2016/464 UMCG: 201600576

Responsible Party

Principal Investigator

Study Sponsor

University Medical Center Groningen

Study Sponsor

MA Mariani, MD, PhD, Principal Investigator, University Medical Center Groningen

Verification Date

April 2019