<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/NCT02997618</url>
  </required_header>
  <id_info>
    <org_study_id>162347</org_study_id>
    <nct_id>NCT02997618</nct_id>
  </id_info>
  <brief_title>The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise in Patients With Abdominal Aortic Aneurysms</brief_title>
  <official_title>The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise to Improve Fitness and Reduce Morbidity and Mortality of Patients With Abdominal Aortic Aneurysms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <has_dmc>No</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>
      Rupture of abdominal aortic aneurysms(AAA) causes 12,000 deaths/year in the UK.1 Elective&#xD;
      repair to prevent this carries a perioperative mortality of 4.5% for open surgery and 1% for&#xD;
      endovascular repair. This risk is associated with poor cardiorespiratory fitness which can be&#xD;
      measured using Cardiopulmonary Exercise Testing(CPET) with the CPET variables, peak oxygen&#xD;
      uptake(peakVO2)&lt;15ml/kg/min and anaerobic threshold(AT)&lt;10.2ml/kg/min identifying patients at&#xD;
      increased risk of early death after AAA repair.3 These variables can therefore be used as&#xD;
      surrogate markers for cardiovascular fitness and risk of mortality and morbidity in AAA&#xD;
      surgery; optimising these markers should improve fitness and decrease this risk. The optimal&#xD;
      duration and type of exercise training for improving peak VO2 and AT in AAA patients is not&#xD;
      known. AAA patients are unique as they are motivated to reduce the risk of impending surgery&#xD;
      but are afforded the time to improve their fitness as repair may not be needed for months or&#xD;
      even years.&#xD;
&#xD;
      The investigators propose a pilot randomised controlled trial to explore the effectiveness of&#xD;
      a 20-week community (either home or gym-based) exercise programme to achieve sustained&#xD;
      improvements in peak VO2 and AT, as measured by CPET, in AAA patients. Changes in QoL,&#xD;
      habitual activity levels and cardiovascular risk will also be assessed. The results will&#xD;
      inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly&#xD;
      patients with cardiovascular disease and AAA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2018</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak VO2 as measured by CPET</measure>
    <time_frame>at 20 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anaerobic Threshold as measured by CPET</measure>
    <time_frame>at 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of Cardiovascular disease risk</measure>
    <time_frame>at 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other risk factors of Cardiovascular disease risk</measure>
    <time_frame>at 20 weeks</time_frame>
    <description>Weight, BMI, Waist Circumference and Blood Pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measure of habitual activity levels (PASE questionnaire)</measure>
    <time_frame>at 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective measure of habitual activity levels (via Accelerometry)</measure>
    <time_frame>at 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>at 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early changes in outcome measures</measure>
    <time_frame>at 10 weeks</time_frame>
    <description>All outcome measures will also be measured at 10 weeks and compared with other time intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustainability of changes in outcome measures</measure>
    <time_frame>at 30 weeks</time_frame>
    <description>All outcome measures recorded 10 weeks post cessation of exercise at 30 weeks and compared with the other time intervals.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Aortic Aneurysm, Abdominal</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1. Usual care (control)&#xD;
Usual care given to patients on AAA surveillance. This includes six-monthly or annual ultrasound measurements of AAA, attendance to surveillance clinic and written (APPENDIX A) and verbal advice on managing cardiovascular risk. This advice will be based on current widely available NHS patient information15 and consists of the following information with regard to:&#xD;
Smoking Exercise Weight Diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community Based Exercise Programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Community based-exercise (in addition to usual care) with the choice of either:&#xD;
Home-based exercise training Participants choosing to exercise at home will follow the programmes intended for this setting, with each exercise designed to be possible without the need for specialist equipment.&#xD;
Gym-based exercise training Participants will exercise at their nearest Life Leisure LTD gym, following one of the instructor designed programmes , using a combination of aerobic and resistance equipment, as well as simple floor exercises.&#xD;
Duration and Frequency At least 50 minutes of exercise per day on three non-consecutive days of the week for 20 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community based exercise programme</intervention_name>
    <description>20 week community (home or gym based) exercise programme</description>
    <arm_group_label>Community Based Exercise Programme</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Usual care consisting of advice.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men with an AAA ≥ 3.0 and &lt; 5.0 cm and women with a AAA ≥ 3.0 and &lt; 4.5 cm&#xD;
&#xD;
          2. Aged 60 - 85 years inclusive&#xD;
&#xD;
          3. Willing and able to engage in gym- and/or home-based exercise training and undertake&#xD;
             CPET&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable or unwilling to undertake CPET or exercise training Patients unwilling will not&#xD;
             be able to give informed consent and those who are unable would not be able to be&#xD;
             randomised to the intervention study group nor undergo satisfactory testing to obtain&#xD;
             our outcome measures.&#xD;
&#xD;
          2. High levels of habitual physical activity (those scoring &quot;high&quot; on the PASE&#xD;
             questionnaire) These patients already have a high level of physical activity and&#xD;
             therefore it may not be possible to improve their fitness any further which is the&#xD;
             primary objective of the study.&#xD;
&#xD;
             Exclusion criteria 3-10 are all based on medical conditions which would mean either&#xD;
             exercise training may be unsafe, they would require further investigation and&#xD;
             treatment of that medical condition or are likely to need upcoming intervention for&#xD;
             their medical condition which would take priority over any participation in a research&#xD;
             study. If any medical conditions are discovered during the study, these patients will&#xD;
             be withdrawn from the study and referred to the necessary health professional.&#xD;
&#xD;
          3. Severe liver disease (INR &gt; 2, serum albumin &lt; 3.0g/dL, bilirubin &gt; 50µmol/L)&#xD;
&#xD;
          4. Unstable angina, angina of &lt; 2 month's duration, occurring more than twice daily,&#xD;
             angina that is increasing in frequency or precipitated by less exertion, angina at&#xD;
             rest&#xD;
&#xD;
          5. Uncontrolled atrial fibrillation (AF) or other arrhythmia: untreated paroxysmal AF&#xD;
&#xD;
          6. Moderate or severe aortic valve stenosis (peak systolic pressure gradient &gt;40mmHg or&#xD;
             with an aortic valve area &lt; 1cm2)&#xD;
&#xD;
          7. Class II/III/IV heart failure and/or left ventricular ejection fraction &lt; 25%&#xD;
&#xD;
          8. Pericarditis or myocarditis within last six months&#xD;
&#xD;
          9. Patients with &gt; 2mm ST depression on exercise ECG will not be eligible to take part&#xD;
             and will be referred to a cardiologist for further assessment.&#xD;
&#xD;
         10. Diagnosis or treatment for a malignancy over the previous 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles McCollum, MD, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adam Haque, MBChB, MRCS</last_name>
    <phone>01612915848</phone>
    <email>adam.haque@manchester.ac.uk</email>
  </overall_contact>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Charles McCollum</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02997618
org study id: 162347
nct id: NCT02997618
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rupture of abdominal aortic aneurysms(AAA) causes 12,000 deaths/year in the UK.1 Elective
      repair to prevent this carries a perioperative mortality of 4.5% for open surgery and 1% for
      endovascular repair. This risk is associated with poor cardiorespiratory fitness which can be
      measured using Cardiopulmonary Exercise Testing(CPET) with the CPET variables, peak oxygen
      uptake(peakVO2)<15ml/kg/min and anaerobic threshold(AT)<10.2ml/kg/min identifying patients at
      increased risk of early death after AAA repair.3 These variables can therefore be used as
      surrogate markers for cardiovascular fitness and risk of mortality and morbidity in AAA
      surgery; optimising these markers should improve fitness and decrease this risk. The optimal
      duration and type of exercise training for improving peak VO2 and AT in AAA patients is not
      known. AAA patients are unique as they are motivated to reduce the risk of impending surgery
      but are afforded the time to improve their fitness as repair may not be needed for months or
      even years.

      The investigators propose a pilot randomised controlled trial to explore the effectiveness of
      a 20-week community (either home or gym-based) exercise programme to achieve sustained
      improvements in peak VO2 and AT, as measured by CPET, in AAA patients. Changes in QoL,
      habitual activity levels and cardiovascular risk will also be assessed. The results will
      inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly
      patients with cardiovascular disease and AAA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Peak VO2 as measured by CPET
time frame: at 20 weeks
measure: Anaerobic Threshold as measured by CPET
time frame: at 20 weeks
measure: Biomarkers of Cardiovascular disease risk
time frame: at 20 weeks
measure: Other risk factors of Cardiovascular disease risk
time frame: at 20 weeks
description: Weight, BMI, Waist Circumference and Blood Pressure
measure: Subjective measure of habitual activity levels (PASE questionnaire)
time frame: at 20 weeks
measure: Objective measure of habitual activity levels (via Accelerometry)
time frame: at 20 weeks
measure: Health-related quality of life
time frame: at 20 weeks
measure: Early changes in outcome measures
time frame: at 10 weeks
description: All outcome measures will also be measured at 10 weeks and compared with other time intervals.
measure: Sustainability of changes in outcome measures
time frame: at 30 weeks
description: All outcome measures recorded 10 weeks post cessation of exercise at 30 weeks and compared with the other time intervals.
arm group label: Control
arm group type: Active Comparator
description: 1. Usual care (control)
Usual care given to patients on AAA surveillance. This includes six-monthly or annual ultrasound measurements of AAA, attendance to surveillance clinic and written (APPENDIX A) and verbal advice on managing cardiovascular risk. This advice will be based on current widely available NHS patient information15 and consists of the following information with regard to:
Smoking Exercise Weight Diet
arm group label: Community Based Exercise Programme
arm group type: Experimental
description: Community based-exercise (in addition to usual care) with the choice of either:
Home-based exercise training Participants choosing to exercise at home will follow the programmes intended for this setting, with each exercise designed to be possible without the need for specialist equipment.
Gym-based exercise training Participants will exercise at their nearest Life Leisure LTD gym, following one of the instructor designed programmes , using a combination of aerobic and resistance equipment, as well as simple floor exercises.
Duration and Frequency At least 50 minutes of exercise per day on three non-consecutive days of the week for 20 weeks.
intervention type: Behavioral
intervention name: Community based exercise programme
description: 20 week community (home or gym based) exercise programme
arm group label: Community Based Exercise Programme
intervention type: Other
intervention name: Control
description: Usual care consisting of advice.
arm group label: Control
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Charles McCollum, MD, FRCS
role: Principal Investigator
affiliation: University of Manchester
last name: Adam Haque, MBChB, MRCS
phone: 01612915848
email: adam.haque@manchester.ac.uk
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Charles McCollum
investigator title: Professor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
sharing ipd: Undecided