xml: <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/NCT06042231</url>
    </required_header>
    <id_info>
      <org_study_id>FO596122</org_study_id>
      <nct_id>NCT06042231</nct_id>
    </id_info>
    <brief_title>Impact of Cardiac Prehabilitation, REhabilitation and Patient EDucation on Outcomes in Patients Undergoing First-time AF Ablation</brief_title>
    <acronym>CREED AF</acronym>
    <official_title>Impact of Cardiac Prehabilitation, REhabilitation and Patient EDucation on Outcomes in Patients Undergoing First-time AF Ablation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospitals Coventry and Warwickshire NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospitals Coventry and Warwickshire NHS Trust</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>
        Atrial fibrillation (AF) is a term used to describe an irregular, and often very rapid,&#xD;
        heartbeat. AF increases the risk of a number of diseases associated with the heart and&#xD;
        cardiovascular system. Ablation is a procedure to treat AF. It uses small burns or freezes to&#xD;
        cause some scarring on the inside of the heart to help break up the electrical signals that&#xD;
        cause irregular heartbeats. This can help the heart maintain a normal rhythm.&#xD;
  &#xD;
        Currently patients who are referred for AF ablation do not receive any additional support as&#xD;
        part of standard care to improve the outcomes of their ablation procedure. Whereas cardiac&#xD;
        rehabilitation is a recognised part of comprehensive care for coronary heart disease patients&#xD;
        (patients whose hearts struggle to receive blood), with exercise and education consistently&#xD;
        identified as central elements to their rehabilitation. This treatment is not yet recommended&#xD;
        for AF ablation patients.&#xD;
  &#xD;
        Therefore, the CREED AF Study is investigating whether a tailored comprehensive exercise and&#xD;
        education intervention can improve outcomes in patients who are undergoing first time AF&#xD;
        ablation. Central to the CREED AF study is the 'prehabilitation' intervention, whereby&#xD;
        exercise and education training will be conducted before AND after AF ablation. 106&#xD;
        participants is the target recruitment, they will be randomised to either receive the CREED&#xD;
        AF intervention (exercise and education intervention before AND after AF ablation) or a&#xD;
        standard care (control) group. The standard care group will receive a one off 1-to-1 patient&#xD;
        education session with a trained practitioner before their AF ablation procedure. This&#xD;
        research study does not affect the AF ablation procedure that patients will have as part of&#xD;
        their standard of care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single centre, prospective, randomised controlled trial. The CREED AF study will&#xD;
        run from University Hospitals Coventry &amp; Warwickshire (UHCW) NHS Trust. There will be&#xD;
        collaboration with Atrium Health, a non-profit exercise rehabilitation centre located in&#xD;
        Coventry, UK. Atrium Health was founded by frontline NHS clinical staff to provide people&#xD;
        with tailored exercise and education programmes. Patients with AF who are referred for&#xD;
        first-time AF ablation at University Hospitals Coventry &amp; Warwickshire NHS Trust will be&#xD;
        recruited to the trial. The aim is to explore the effectiveness of a tailored comprehensive&#xD;
        cardiac rehabilitation programme (both before and after the planned AF ablation) comprising&#xD;
        of an exercise programme and patient education programme incorporating lifestyle behaviour&#xD;
        change (CREED AF intervention), compared to standard care (control arm).&#xD;
  &#xD;
        The CREED AF intervention will involve a cardiac pre/rehabilitation exercise training&#xD;
        programme combined with a patient education programme.&#xD;
  &#xD;
        To ensure generalisability for future trials, provisions will be based on current delivery&#xD;
        models of cardiac rehabilitation in cardiovascular diseases. A 6-8-week supported programme&#xD;
        of 2-3 times weekly exercise will be delivered with an initial individual assessment for each&#xD;
        patient randomised to the intervention. Participants will attend a one-to-one appointment&#xD;
        with a 'CREED AF practitioner' (specialist cardio-pulmonary clinical exercise physiologist or&#xD;
        physiotherapist) for the assessment of medical history, medication, clinical parameters,&#xD;
        physical activity history and discussion of participant goals, expectations, fears, and&#xD;
        concerns. Patients randomised to the CREED AF intervention will have access to both existing&#xD;
        cardio-pulmonary rehabilitation programmes at the Atrium Health Centre, Coventry (i.e., they&#xD;
        will exercise alongside people with a range of cardio-pulmonary disorders at already running&#xD;
        sessions) AND instructor-led, at home workout sessions that will take place live over a video&#xD;
        conferencing software. It is anticipated that participants randomised to the CREED AF&#xD;
        intervention will choose to receive a hybrid of the two approaches to reduce travel&#xD;
        constraints of getting to and from the Atrium Health Centre, and to work more flexibly around&#xD;
        a participant's working/personal life. To maximise accessibility and resource, whilst&#xD;
        ensuring benefits are retained, the CREED AF intervention will be delivered as a 'rolling'&#xD;
        programme. Participants randomised to the CREED AF intervention can immediately join existing&#xD;
        cardio-pulmonary rehabilitation exercise programmes rather than waiting for the recruitment&#xD;
        of sufficient numbers to form a discrete group of trial participants.&#xD;
  &#xD;
        Cardiac pre/rehabilitation This will be a tailored, individualised exercise programme within&#xD;
        pre-specified parameters. Clinical information, data from the exercise assessment, and&#xD;
        patient-centred goal setting will be used to devise a safe and effective exercise&#xD;
        prescription which can be performed either using pre-existing cardiopulmonary exercise groups&#xD;
        at Atrium Health or using the instructor-led online classes that will be available. Exercise&#xD;
        guidance, specific to AF, will be delivered on an individual basis during a 1-to-1&#xD;
        familiarisation exercise session in the first week of the programme, and reinforced&#xD;
        throughout, by clinical staff. Familiarisation sessions, conducted within the cardiopulmonary&#xD;
        rehabilitation programmes will enable participants to build their confidence and there will&#xD;
        be optimisation of the exercise prescribed.&#xD;
  &#xD;
        The cardiac rehabilitation can be undertaken within existing cardio-pulmonary rehabilitation&#xD;
        programmes delivered by NHS clinical staff. Up to 3 times weekly, one hour, exercise sessions&#xD;
        for 6-8 weeks before and for 6-8 weeks after AF ablation, with a quantifiable and progressive&#xD;
        dose of individualised, multi-modal, aerobic, muscular strength, endurance and 'functional&#xD;
        fitness' exercise. Adequate warm-up and cool-down will be incorporated. Intensity can be&#xD;
        monitored and adjusted using heart rate (where appropriate), rating of perceived exertion,&#xD;
        and dyspnoea scale. There is normally a 1-2-week recovery period after an AF ablation&#xD;
        procedure to allow for femoral access site wound healing. Only after the participant has&#xD;
        completed this 2-week recovery period will they restart their exercise intervention.&#xD;
  &#xD;
        The exercise component will be optimised to be appropriate for a broad spectrum of patients&#xD;
        including frailer, deconditioned, low-mobility, exercise-naive participants. Conventional gym&#xD;
        exercise will be combined with 'functional fitness' training. The programme will be highly&#xD;
        adaptable to allow personalisation to lower or higher ability participants, whilst ensuring&#xD;
        safety and efficacy. This is widespread practice within cardio-pulmonary rehabilitation&#xD;
        programmes in the UK.&#xD;
  &#xD;
        In addition to treadmills, cycles, and rowing ergometers, readily available functional&#xD;
        fitness equipment such as steps, floor agility ladders, low rise balance beams, power bags,&#xD;
        plyometric boxes, balls (throw/bounce) etc will be made use of. A range of body weight&#xD;
        exercises for online sessions at home will also be utilised. Central to our intervention is&#xD;
        the expertise and experience of the specialist CREED AF practitioner who will ensure&#xD;
        holistic, safe, individualised, and effective exercise training.&#xD;
  &#xD;
        Education, behavioural and lifestyle AF risk Factor Modification Support The education&#xD;
        programme will be delivered in 1-to-1 sessions with a delegated and qualified member of the&#xD;
        research team which can be delivered either face-to-face or via an online video conferencing&#xD;
        software. The education session will be delivered as part of the CREED AF intervention.&#xD;
        Changing behaviours can be difficult and the importance of psychological support in AF&#xD;
        patients is recognised. Therefore, discussions with individuals on motivation to change,&#xD;
        barriers to change, goal setting and problem-solving to build self-efficacy and encourage&#xD;
        behaviour change, adherence, and compliance to risk factor modification will be incorporated.&#xD;
        Every second week (a total of 6 1-to-1 education sessions, 3 sessions in prehabilitation&#xD;
        before ablation, and 3 sessions in rehabilitation after ablation), before or after exercise,&#xD;
        participants will receive a 1-to-1 30-minute behavioural and motivational session with the&#xD;
        aim of improving short- and long-term adherence to exercise and lifestyle modification goals.&#xD;
        The aim of this will be to provide help to patients to manage lifestyle risk factors. These&#xD;
        will include reduction of alcohol consumption to less than 2 Units per day (in line with&#xD;
        current UK government guidelines), ensure good blood pressure control in line with&#xD;
        international guidelines (&lt;140/85mmHg), provide smoking cessation support, help with good&#xD;
        diabetes control, advice on weight reduction management (through diet and exercise) and&#xD;
        identification and treatment of obstructive sleep apnoea (OSA). Patients in the intervention&#xD;
        group will be provided with written materials, including but not limited to a patient&#xD;
        workbook and publicly available patient information leaflets, with sign-posting to support&#xD;
        groups as applicable to each individual.&#xD;
  &#xD;
        The CPET will be performed by both the control and intervention groups at baseline and 10&#xD;
        weeks (±2 weeks) post-ablation. The test will be used to assess exercise capacity and will&#xD;
        give an indicator of the participant's cardiorespiratory fitness. The tests will be performed&#xD;
        at UHCW's respiratory laboratory. The lab is UKAS accredited to IQIPS standard to perform&#xD;
        CPET. The local UHCW standard operating procedure for CPET will be followed for all&#xD;
        participants during their VO2peak test. This information is available in full detail in a&#xD;
        separate document, but briefly:&#xD;
  &#xD;
          1. The participant will have their height and weight measured and information about the&#xD;
             current medications collected.&#xD;
  &#xD;
          2. They will have the procedure explained to them in full detail and any questions they&#xD;
             have will be answered.&#xD;
  &#xD;
          3. A spirometry measurement of forced vital capacity will be obtained before the CPET&#xD;
             begins.&#xD;
  &#xD;
          4. A 12-lead ECG will be attached to the participant.&#xD;
  &#xD;
          5. A Hans Rudolph face mask will be fitted to the participant and baseline data collected.&#xD;
  &#xD;
          6. A blood pressure cuff and pulse oximeter will be attached with measurements taken at&#xD;
             baseline and during the test.&#xD;
  &#xD;
          7. The exercise protocol will begin with increasing exercise intensity until the&#xD;
             participant feels they cannot continue, when cadence falls by 5% or more or when the&#xD;
             individual leading the exercise test requests it to be stopped.&#xD;
  &#xD;
          8. Recovery period involving low intensity exercise.&#xD;
  &#xD;
        Participants who are randomised into the control group will also receive a 30-minute 1-to-1&#xD;
        education session (remotely or in person) from a CREED AF practitioner before their AF&#xD;
        ablation to go through the risk factors of AF and what they can do to improve their health.&#xD;
        The session will involve a discussion with the participant around risk factors related to AF&#xD;
        and recommendations for what actions the participant should take to minimise these factors,&#xD;
        sign-posting to publicly available patient information leaflets (e.g.&#xD;
        https://heartrhythmalliance.org/aa/uk/resources/arrhythmia-alliance-patient-resources). For&#xD;
        the rest of the trial, they will follow the standard care pathway for ablation patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>VO2 peak measurements</measure>
      <time_frame>12 months</time_frame>
      <description>VO2peak measured from cardiopulmonary exercise testing (CPET) at baseline and 10 weeks (±2 weeks) post AF ablation between the standard care and intervention arms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of life questionnaire</measure>
      <time_frame>12 months</time_frame>
      <description>EQ-5D-5L questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life questionnaire</measure>
      <time_frame>12 months</time_frame>
      <description>SF-36 QoL Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life questionnaire</measure>
      <time_frame>12 months</time_frame>
      <description>Atrial Fibrillation Effect on Quality-of-Life (AFEQT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost effectiveness of CREED AF intervention</measure>
      <time_frame>12 months</time_frame>
      <description>Incremental cost per quality adjusted life year (QALY).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AF recurrence in short- and long-term</measure>
      <time_frame>12 months</time_frame>
      <description>AF recurrence and burden from data collected from a 1-7-day(s) cardiac Holter monitoring at 10 weeks (±2 weeks) and 12 months (±4 weeks) post ablation, and requirement for redo-AF ablation as documented in medical records reviewed at 12 months post-ablation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurence of Major Adverse Cardiovascular Events (MACE)</measure>
      <time_frame>12 months</time_frame>
      <description>MACE recorded at 12 months post-ablation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">106</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Exercise Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise Intervention</intervention_name>
      <description>Exercise and education intervention. Participants will be prescribed a tailored exercise program to complete before ('pre-habilitation') and after their AF ablation procedure (rehabilitation).</description>
      <arm_group_label>Exercise Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Education Intervention</intervention_name>
      <description>Education intervention. Participants will be given a 1-1 education session (up to 3 sessions) before and after their AF ablation procedure. Participants will be given behavioural strategies to improve adherence and compliancec to risk-factor modification.</description>
      <arm_group_label>Exercise Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients listed for a first-time AF ablation procedure&#xD;
  &#xD;
            -  Patients aged ≥18 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Lack of capacity to consent and participate&#xD;
  &#xD;
            -  Presence of contraindications or limiting physical or mental health co-morbidity&#xD;
               preventing travel, safe exercise, or productive engagement with the trial&#xD;
  &#xD;
            -  Unable to access online exercise and support sessions from home&#xD;
  &#xD;
            -  Participating in a research trial that will impact on their standard AF ablation&#xD;
               procedure&#xD;
  &#xD;
            -  Unable to understand basic spoken and written English&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Faizel Osman</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospitals Coventry &amp; Warwickshre NHS Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Violet Matthews, BSc</last_name>
      <phone>02476966197</phone>
      <email>violet.matthews@uhcw.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nakul Chandan</last_name>
      <email>nakul.chandan@uhcw.nhs.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital Coventry and Warwickshire NHS Trust</name>
        <address>
          <city>Coventry</city>
          <state>West Midlands</state>
          <zip>CV22DX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Violet Matthews, BSc</last_name>
        <phone>02476966197</phone>
        <phone_ext>26197</phone_ext>
        <email>violet.matthews@uhcw.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Faizel Osman</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>AF ablation</keyword>
    <keyword>Pulmonary vein isolation</keyword>
    <keyword>VO2peak</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042231
  org study id: FO596122
  nct id: NCT06042231
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Atrial fibrillation (AF) is a term used to describe an irregular, and often very rapid,
        heartbeat. AF increases the risk of a number of diseases associated with the heart and
        cardiovascular system. Ablation is a procedure to treat AF. It uses small burns or freezes to
        cause some scarring on the inside of the heart to help break up the electrical signals that
        cause irregular heartbeats. This can help the heart maintain a normal rhythm.
  
        Currently patients who are referred for AF ablation do not receive any additional support as
        part of standard care to improve the outcomes of their ablation procedure. Whereas cardiac
        rehabilitation is a recognised part of comprehensive care for coronary heart disease patients
        (patients whose hearts struggle to receive blood), with exercise and education consistently
        identified as central elements to their rehabilitation. This treatment is not yet recommended
        for AF ablation patients.
  
        Therefore, the CREED AF Study is investigating whether a tailored comprehensive exercise and
        education intervention can improve outcomes in patients who are undergoing first time AF
        ablation. Central to the CREED AF study is the 'prehabilitation' intervention, whereby
        exercise and education training will be conducted before AND after AF ablation. 106
        participants is the target recruitment, they will be randomised to either receive the CREED
        AF intervention (exercise and education intervention before AND after AF ablation) or a
        standard care (control) group. The standard care group will receive a one off 1-to-1 patient
        education session with a trained practitioner before their AF ablation procedure. This
        research study does not affect the AF ablation procedure that patients will have as part of
        their standard of care.
  This is a single centre, prospective, randomised controlled trial. The CREED AF study will
        run from University Hospitals Coventry & Warwickshire (UHCW) NHS Trust. There will be
        collaboration with Atrium Health, a non-profit exercise rehabilitation centre located in
        Coventry, UK. Atrium Health was founded by frontline NHS clinical staff to provide people
        with tailored exercise and education programmes. Patients with AF who are referred for
        first-time AF ablation at University Hospitals Coventry & Warwickshire NHS Trust will be
        recruited to the trial. The aim is to explore the effectiveness of a tailored comprehensive
        cardiac rehabilitation programme (both before and after the planned AF ablation) comprising
        of an exercise programme and patient education programme incorporating lifestyle behaviour
        change (CREED AF intervention), compared to standard care (control arm).
  
        The CREED AF intervention will involve a cardiac pre/rehabilitation exercise training
        programme combined with a patient education programme.
  
        To ensure generalisability for future trials, provisions will be based on current delivery
        models of cardiac rehabilitation in cardiovascular diseases. A 6-8-week supported programme
        of 2-3 times weekly exercise will be delivered with an initial individual assessment for each
        patient randomised to the intervention. Participants will attend a one-to-one appointment
        with a 'CREED AF practitioner' (specialist cardio-pulmonary clinical exercise physiologist or
        physiotherapist) for the assessment of medical history, medication, clinical parameters,
        physical activity history and discussion of participant goals, expectations, fears, and
        concerns. Patients randomised to the CREED AF intervention will have access to both existing
        cardio-pulmonary rehabilitation programmes at the Atrium Health Centre, Coventry (i.e., they
        will exercise alongside people with a range of cardio-pulmonary disorders at already running
        sessions) AND instructor-led, at home workout sessions that will take place live over a video
        conferencing software. It is anticipated that participants randomised to the CREED AF
        intervention will choose to receive a hybrid of the two approaches to reduce travel
        constraints of getting to and from the Atrium Health Centre, and to work more flexibly around
        a participant's working/personal life. To maximise accessibility and resource, whilst
        ensuring benefits are retained, the CREED AF intervention will be delivered as a 'rolling'
        programme. Participants randomised to the CREED AF intervention can immediately join existing
        cardio-pulmonary rehabilitation exercise programmes rather than waiting for the recruitment
        of sufficient numbers to form a discrete group of trial participants.
  
        Cardiac pre/rehabilitation This will be a tailored, individualised exercise programme within
        pre-specified parameters. Clinical information, data from the exercise assessment, and
        patient-centred goal setting will be used to devise a safe and effective exercise
        prescription which can be performed either using pre-existing cardiopulmonary exercise groups
        at Atrium Health or using the instructor-led online classes that will be available. Exercise
        guidance, specific to AF, will be delivered on an individual basis during a 1-to-1
        familiarisation exercise session in the first week of the programme, and reinforced
        throughout, by clinical staff. Familiarisation sessions, conducted within the cardiopulmonary
        rehabilitation programmes will enable participants to build their confidence and there will
        be optimisation of the exercise prescribed.
  
        The cardiac rehabilitation can be undertaken within existing cardio-pulmonary rehabilitation
        programmes delivered by NHS clinical staff. Up to 3 times weekly, one hour, exercise sessions
        for 6-8 weeks before and for 6-8 weeks after AF ablation, with a quantifiable and progressive
        dose of individualised, multi-modal, aerobic, muscular strength, endurance and 'functional
        fitness' exercise. Adequate warm-up and cool-down will be incorporated. Intensity can be
        monitored and adjusted using heart rate (where appropriate), rating of perceived exertion,
        and dyspnoea scale. There is normally a 1-2-week recovery period after an AF ablation
        procedure to allow for femoral access site wound healing. Only after the participant has
        completed this 2-week recovery period will they restart their exercise intervention.
  
        The exercise component will be optimised to be appropriate for a broad spectrum of patients
        including frailer, deconditioned, low-mobility, exercise-naive participants. Conventional gym
        exercise will be combined with 'functional fitness' training. The programme will be highly
        adaptable to allow personalisation to lower or higher ability participants, whilst ensuring
        safety and efficacy. This is widespread practice within cardio-pulmonary rehabilitation
        programmes in the UK.
  
        In addition to treadmills, cycles, and rowing ergometers, readily available functional
        fitness equipment such as steps, floor agility ladders, low rise balance beams, power bags,
        plyometric boxes, balls (throw/bounce) etc will be made use of. A range of body weight
        exercises for online sessions at home will also be utilised. Central to our intervention is
        the expertise and experience of the specialist CREED AF practitioner who will ensure
        holistic, safe, individualised, and effective exercise training.
  
        Education, behavioural and lifestyle AF risk Factor Modification Support The education
        programme will be delivered in 1-to-1 sessions with a delegated and qualified member of the
        research team which can be delivered either face-to-face or via an online video conferencing
        software. The education session will be delivered as part of the CREED AF intervention.
        Changing behaviours can be difficult and the importance of psychological support in AF
        patients is recognised. Therefore, discussions with individuals on motivation to change,
        barriers to change, goal setting and problem-solving to build self-efficacy and encourage
        behaviour change, adherence, and compliance to risk factor modification will be incorporated.
        Every second week (a total of 6 1-to-1 education sessions, 3 sessions in prehabilitation
        before ablation, and 3 sessions in rehabilitation after ablation), before or after exercise,
        participants will receive a 1-to-1 30-minute behavioural and motivational session with the
        aim of improving short- and long-term adherence to exercise and lifestyle modification goals.
        The aim of this will be to provide help to patients to manage lifestyle risk factors. These
        will include reduction of alcohol consumption to less than 2 Units per day (in line with
        current UK government guidelines), ensure good blood pressure control in line with
        international guidelines (<140/85mmHg), provide smoking cessation support, help with good
        diabetes control, advice on weight reduction management (through diet and exercise) and
        identification and treatment of obstructive sleep apnoea (OSA). Patients in the intervention
        group will be provided with written materials, including but not limited to a patient
        workbook and publicly available patient information leaflets, with sign-posting to support
        groups as applicable to each individual.
  
        The CPET will be performed by both the control and intervention groups at baseline and 10
        weeks (±2 weeks) post-ablation. The test will be used to assess exercise capacity and will
        give an indicator of the participant's cardiorespiratory fitness. The tests will be performed
        at UHCW's respiratory laboratory. The lab is UKAS accredited to IQIPS standard to perform
        CPET. The local UHCW standard operating procedure for CPET will be followed for all
        participants during their VO2peak test. This information is available in full detail in a
        separate document, but briefly:
  
          1. The participant will have their height and weight measured and information about the
             current medications collected.
  
          2. They will have the procedure explained to them in full detail and any questions they
             have will be answered.
  
          3. A spirometry measurement of forced vital capacity will be obtained before the CPET
             begins.
  
          4. A 12-lead ECG will be attached to the participant.
  
          5. A Hans Rudolph face mask will be fitted to the participant and baseline data collected.
  
          6. A blood pressure cuff and pulse oximeter will be attached with measurements taken at
             baseline and during the test.
  
          7. The exercise protocol will begin with increasing exercise intensity until the
             participant feels they cannot continue, when cadence falls by 5% or more or when the
             individual leading the exercise test requests it to be stopped.
  
          8. Recovery period involving low intensity exercise.
  
        Participants who are randomised into the control group will also receive a 30-minute 1-to-1
        education session (remotely or in person) from a CREED AF practitioner before their AF
        ablation to go through the risk factors of AF and what they can do to improve their health.
        The session will involve a discussion with the participant around risk factors related to AF
        and recommendations for what actions the participant should take to minimise these factors,
        sign-posting to publicly available patient information leaflets (e.g.
        https://heartrhythmalliance.org/aa/uk/resources/arrhythmia-alliance-patient-resources). For
        the rest of the trial, they will follow the standard care pathway for ablation patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: VO2 peak measurements
  time frame: 12 months
  description: VO2peak measured from cardiopulmonary exercise testing (CPET) at baseline and 10 weeks (±2 weeks) post AF ablation between the standard care and intervention arms.
  measure: Quality of life questionnaire
  time frame: 12 months
  description: EQ-5D-5L questionnaire
  measure: Quality of life questionnaire
  time frame: 12 months
  description: SF-36 QoL Scale
  measure: Quality of life questionnaire
  time frame: 12 months
  description: Atrial Fibrillation Effect on Quality-of-Life (AFEQT)
  measure: Cost effectiveness of CREED AF intervention
  time frame: 12 months
  description: Incremental cost per quality adjusted life year (QALY).
  measure: AF recurrence in short- and long-term
  time frame: 12 months
  description: AF recurrence and burden from data collected from a 1-7-day(s) cardiac Holter monitoring at 10 weeks (±2 weeks) and 12 months (±4 weeks) post ablation, and requirement for redo-AF ablation as documented in medical records reviewed at 12 months post-ablation.
  measure: Occurence of Major Adverse Cardiovascular Events (MACE)
  time frame: 12 months
  description: MACE recorded at 12 months post-ablation
  arm group label: Exercise Intervention
  arm group type: Experimental
  arm group label: Standard Care
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Exercise Intervention
  description: Exercise and education intervention. Participants will be prescribed a tailored exercise program to complete before ('pre-habilitation') and after their AF ablation procedure (rehabilitation).
  arm group label: Exercise Intervention
  intervention type: Behavioral
  intervention name: Education Intervention
  description: Education intervention. Participants will be given a 1-1 education session (up to 3 sessions) before and after their AF ablation procedure. Participants will be given behavioural strategies to improve adherence and compliancec to risk-factor modification.
  arm group label: Exercise Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Faizel Osman
  role: Principal Investigator
  affiliation: University Hospitals Coventry & Warwickshre NHS Trust
  last name: Violet Matthews, BSc
  phone: 02476966197
  email: violet.matthews@uhcw.nhs.uk
  last name: Nakul Chandan
  email: nakul.chandan@uhcw.nhs.uk
  facility: 
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation