<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02984449</url>
  </required_header>
  <id_info>
    <org_study_id>METc: 2016/464 UMCG: 201600576</org_study_id>
    <nct_id>NCT02984449</nct_id>
  </id_info>
  <brief_title>Preventive Heart Rehabilitation to Prevent Complications in Patients Undergoing Elective Open Heart Surgery</brief_title>
  <acronym>Heart-ROCQ</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale:&#xD;
&#xD;
      Patients undergoing cardiac surgery are at risk of developing perioperative complications and&#xD;
      major adverse cardiac events, mainly related to both their preoperative status and type of&#xD;
      surgical procedure. Postoperative exercise based cardiac rehabilitation (CR) is an effective&#xD;
      therapy to prolong survival and improve quality of life. However, little is known about the&#xD;
      effect on post-operative complications, quality of life and return to work of a combined pre-&#xD;
      and post-operative CR program encompassing physical therapy, dietary counseling,&#xD;
      psychological support and life style management compared to a CR program, which is provided&#xD;
      only after cardiac surgery.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      to determine whether a pre- and postoperative (PRE+POST) CR program improves the short (up to&#xD;
      three months) and long term outcomes (up to one year) of the cardiac surgery (i.e. reduction&#xD;
      in postoperative surgical complications, readmissions to hospital and major adverse cardiac&#xD;
      events in conjunction with improvements in the physical component of health related quality&#xD;
      of life), when compared to postoperative CR only (POST).&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      A Prospective Randomized Open controlled trial, Blinded End-point. Patients are randomized&#xD;
      between two standard care CR programs. One group will start a the POST CR program after&#xD;
      surgery. The other group will be randomized to a combined PRE+POST CR program.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Patients (age &gt; 18 years) admitted for elective coronary bypass surgery, valve surgery and/or&#xD;
      aortic surgery&#xD;
&#xD;
      Main study parameters/endpoints:&#xD;
&#xD;
      The primary outcome is a composite weighted endpoint of postoperative surgical complications,&#xD;
      re-admissions to hospital, major adverse cardiac events and health related quality of life&#xD;
      (two domains: physical functioning and physical problem), at three months and one year after&#xD;
      surgery. Endpoints are determined by an independent endpoint committee, blinded to the group&#xD;
      allocation. Secondary, the study focuses on physical health (cardiorespiratory fitness,&#xD;
      muscle strength and functional status), psychological health (feelings of anxiety and&#xD;
      depression), work participation, economics, lifestyle risk factors (physical activity and&#xD;
      smoking behavior), self-efficacy and illness representations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events</measure>
    <time_frame>Up to one year post-surgery</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation</measure>
    <time_frame>up to one year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prolonged stay at the intensive care unit</measure>
    <time_frame>up to one year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>re-thoracotomy</measure>
    <time_frame>up to one year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>re-admissions to intensive care unit</measure>
    <time_frame>up to one year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>re-admissions to hospital</measure>
    <time_frame>up to one year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>up to five year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>six minutes walking test</measure>
    <time_frame>Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle strength</measure>
    <time_frame>Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery</time_frame>
    <description>This will include grip strength and knee extension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional status (KATZ)</measure>
    <time_frame>Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (Rand-36-v2)</measure>
    <time_frame>Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression (PHQ-9)</measure>
    <time_frame>Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety (GAD)</measure>
    <time_frame>Baseline, one day before surgery, 4-7 days, 3-4 months and one year after surgery</time_frame>
    <description>Depression (PHQ-9), anxiety (GAD), Quality of life (Rand-36-v2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iMTA Productivity Cost Questionnaire (PCQ)</measure>
    <time_frame>Baseline, 3-4, 7-8 and 12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iMTA Medical Cost Questionnaire (MCQ)</measure>
    <time_frame>Baseline, 3-4, 7-8 and 12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifestyle risk factors</measure>
    <time_frame>Baseline, 3-4 months and one year post-surgery</time_frame>
    <description>Physical activity is assessed using the Sensewear GECKO mini-armband (SWA) and the long version (27 questions) of the International Physical Activity Questionnaire (iPAQ)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Illness perception (IPQ-R),</measure>
    <time_frame>Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac self-efficacy scale (CSA)</measure>
    <time_frame>Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Coronary (Artery); Disease</condition>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Pre+postoperative Cardiac rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postoperative Cardiac rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pre+post-operative Cardiac rehabilitation</intervention_name>
    <description>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).</description>
    <arm_group_label>Pre+postoperative Cardiac rehabilitation</arm_group_label>
    <other_name>Exercise</other_name>
    <other_name>physical fitness</other_name>
    <other_name>nutrition</other_name>
    <other_name>psychological support</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Postoperative Cardiac rehabilitation</intervention_name>
    <description>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).</description>
    <arm_group_label>Postoperative Cardiac rehabilitation</arm_group_label>
    <other_name>Exercise</other_name>
    <other_name>physical fitness</other_name>
    <other_name>nutrition</other_name>
    <other_name>psychological support</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the department of Thoracic Surgery of the UMCG for:&#xD;
&#xD;
          -  coronary artery bypass graft surgery&#xD;
&#xD;
          -  valve surgery&#xD;
&#xD;
          -  aortic surgery&#xD;
&#xD;
          -  or a combination of the surgeries mentioned above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients accepted for transcatheter aortic valve implantation (TAVI)&#xD;
&#xD;
          -  Patients undergoing congenital heart surgery&#xD;
&#xD;
          -  Aortic descendens or dissections surgery&#xD;
&#xD;
          -  Elite athletes&#xD;
&#xD;
          -  Co-morbidities that prevent participation in one or more program elements (e.g.&#xD;
             disorders to the nervous or musculoskeletal system that limits exercise capacity,&#xD;
             severe COPD (GOLD class 3-4), addiction to alcohol or drugs/ serious psychiatric&#xD;
             illness) or when it is undesirable to exercise (e.g. cardiomyopathy/morrow).&#xD;
&#xD;
          -  Other treatment planned that possibly will interrupt the program (for example on a&#xD;
             waiting list for an organ transplantation, preoperative endocarditis or planned&#xD;
             chemotherapy for cancer etc.)&#xD;
&#xD;
          -  Unable to read, write and understand Dutch&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MA Mariani, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>MA Mariani, MD, PhD</last_name>
    <phone>0031503613238</phone>
    <email>m.mariani@umcg.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>J Hartog, MSc</last_name>
    <phone>0031503617527</phone>
    <email>j.hartog@umcg.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>J. Hartog, MSc</last_name>
      <phone>0031503617527</phone>
      <email>j.hartog@umcg.nl</email>
    </contact>
    <contact_backup>
      <last_name>M.A. Mariani, PhD, MSc</last_name>
      <phone>0031503613238</phone>
      <email>m.mariani@umcg.nl</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>April 26, 2019</last_update_submitted>
  <last_update_submitted_qc>April 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>M.A. Mariani</investigator_full_name>
    <investigator_title>Prof. Dr. M.A. Mariani</investigator_title>
  </responsible_party>
  <keyword>cardiac rehabilitation</keyword>
  <keyword>surgical complications</keyword>
  <keyword>quality of life</keyword>
  <keyword>preoperative</keyword>
  <keyword>cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT02984449/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02984449
org study id: METc: 2016/464 UMCG: 201600576
nct id: NCT02984449
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: 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.
measure: a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events
time frame: Up to one year post-surgery
description: 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.
measure: Atrial fibrillation
time frame: up to one year post-surgery
measure: prolonged stay at the intensive care unit
time frame: up to one year post-surgery
measure: re-thoracotomy
time frame: up to one year post-surgery
measure: re-admissions to intensive care unit
time frame: up to one year post-surgery
measure: re-admissions to hospital
time frame: up to one year post-surgery
measure: All-cause mortality
time frame: up to five year post-surgery
measure: six minutes walking test
time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: muscle strength
time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
description: This will include grip strength and knee extension
measure: functional status (KATZ)
time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: Quality of life (Rand-36-v2)
time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: Depression (PHQ-9)
time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: Anxiety (GAD)
time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year after surgery
description: Depression (PHQ-9), anxiety (GAD), Quality of life (Rand-36-v2)
measure: iMTA Productivity Cost Questionnaire (PCQ)
time frame: Baseline, 3-4, 7-8 and 12 months post-surgery
measure: iMTA Medical Cost Questionnaire (MCQ)
time frame: Baseline, 3-4, 7-8 and 12 months post-surgery
measure: Lifestyle risk factors
time frame: Baseline, 3-4 months and one year post-surgery
description: Physical activity is assessed using the Sensewear GECKO mini-armband (SWA) and the long version (27 questions) of the International Physical Activity Questionnaire (iPAQ)
measure: Illness perception (IPQ-R),
time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
measure: Cardiac self-efficacy scale (CSA)
time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
arm group label: Pre+postoperative Cardiac rehabilitation
arm group type: Experimental
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
arm group label: Postoperative Cardiac rehabilitation
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Pre+post-operative Cardiac rehabilitation
description: 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).
arm group label: Pre+postoperative Cardiac rehabilitation
other name: Exercise
other name: physical fitness
other name: nutrition
other name: psychological support
intervention type: Behavioral
intervention name: Postoperative Cardiac rehabilitation
description: 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).
arm group label: Postoperative Cardiac rehabilitation
other name: Exercise
other name: physical fitness
other name: nutrition
other name: psychological support
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MA Mariani, MD, PhD
role: Principal Investigator
affiliation: University Medical Center Groningen
last name: MA Mariani, MD, PhD
phone: 0031503613238
email: m.mariani@umcg.nl
last name: J Hartog, MSc
phone: 0031503617527
email: j.hartog@umcg.nl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: M.A. Mariani
investigator title: Prof. Dr. M.A. Mariani
mesh term: Aortic Valve Stenosis
mesh term: Coronary Artery Disease
mesh term: Coronary Disease
sharing ipd: No
provided document: 