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/NCT06032013</url>
    </required_header>
    <id_info>
      <org_study_id>National School Public Health</org_study_id>
      <nct_id>NCT06032013</nct_id>
    </id_info>
    <brief_title>Patient-Reported Outcome Measures in Cardiac Rehabilitation: Impact on Health Care</brief_title>
    <acronym>PROM_R</acronym>
    <official_title>Patient-Reported Outcome Measures and Quality of Life in Cardiac Rehabilitation: Impact on Health Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>José Manuel Afonso Moreira</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Évora</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>
        Cardiac Rehabilitation (CR) programs are a multidisciplinary process aimed at patient&#xD;
        recovery after an acute cardiovascular event or with chronic heart disease, reducing&#xD;
        mortality and morbidity, optimising functional capacity and improving quality of life. The&#xD;
        aim is to maintain or recover the patient's clinical, physical and psychosocial condition,&#xD;
        slowing down or halting the progression of the underlying disease process. It is based on the&#xD;
        practice of personalized physical exercise and the adaptation of behaviours towards a&#xD;
        healthier lifestyle, ensuring the reduction and control of risk factors. It is considered a&#xD;
        cost-effective intervention that is explicitly and formally recommended by the most diverse&#xD;
        and important scientific societies. Through the partnership and collaboration between the&#xD;
        various health institutions and the academy, the CR program will take place on an outpatient&#xD;
        basis, in a supervised manner, starting after risk stratification with a stress test and&#xD;
        respective clinical assessment by a cardiologist. The coordinator of the CR program will be a&#xD;
        cardiologist, and the entire multidisciplinary team will be responsible for effectiveness and&#xD;
        safety, as well as patient assessment and progress.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The outpatient CR program is designed for a group of participants who have had a cardiac&#xD;
        event, based on the American College of Sports Medicine's Guidelines for Exercise Testing and&#xD;
        Prescription, consisting of two exercise sessions/week. The sessions are supervised by a&#xD;
        healthcare professional specialising in cardiac rehabilitation, and the participant's&#xD;
        haemodynamic status is monitored continuously using scales and electronic equipment. PROMs&#xD;
        will be applied before and after the program.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>EQ5D-5L: Health-related quality of life</measure>
      <time_frame>Before the intervention and up to 8 weeks.</time_frame>
      <description>The EQ5D makes it possible to assess quality of life in a given pathology in the general population, presented in different domains. The visual analogue scale of this questionnaire has a score of 0-100. Higher scores mean a better result.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HADS: Anxiety and depression</measure>
      <time_frame>Before the intervention and up to 8 weeks.</time_frame>
      <description>Participants' anxiety and worries are also assessed. Mood disorders, weakness, worry, stress, and depression are common psychological repercussions for patients after a cardiac event, which can trigger hyperventilation reactions. This type of common reaction to emotional extremes such as fear, anxiety, or stress in participants can have a direct impact on involvement in CR programs. This questionnaire is made up of 14 questions. Lower scores mean a better result.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>Before, during and up to 8 weeks of the program.</time_frame>
      <description>Heart rate (bpm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Before, during and up to 8 weeks of the program.</time_frame>
      <description>Blood pressure (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peripheral oxygen saturation</measure>
      <time_frame>Before, during and up to 8 weeks of the program.</time_frame>
      <description>Peripheral oxygen saturation (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exercise Capacity</measure>
      <time_frame>During and up to 8 weeks of the program.</time_frame>
      <description>Borg scale- score 0-10. Higher values mean greater respiratory effort.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>Before the intervention and up to 8 weeks.</time_frame>
      <description>Weight (Kg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Abdominal perimeter</measure>
      <time_frame>Before the intervention and up to 8 weeks.</time_frame>
      <description>Abdominal perimeter (cm)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Quality of Life</condition>
    <condition>Cardiac Rehabilitation</condition>
    <condition>Patient-Reported Outcome Measures</condition>
    <condition>Rehabilitation Exercise</condition>
    <arm_group>
      <arm_group_label>Cardiac Rehabilitation intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Outpatient intervention with participants after a cardiac event who fulfil the inclusion criteria.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cardiac rehabilitation program (PROMs)</intervention_name>
      <description>The program is multidisciplinary with the following components:&#xD;
  Medical assessment&#xD;
  Physical training and counselling on physical activity&#xD;
  Identification and control of risk factors&#xD;
  Nutritional assessment and counselling&#xD;
  Psychological assessment and intervention&#xD;
  Education and information</description>
      <arm_group_label>Cardiac Rehabilitation intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult (&gt; 18 years);&#xD;
  &#xD;
            -  Low-moderate risk for physical exercise;&#xD;
  &#xD;
            -  After a cardiac event;&#xD;
  &#xD;
            -  Have signed an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Physical or mental limitation to carry out an exercise programme;&#xD;
  &#xD;
            -  Uncontrolled arrhythmia;&#xD;
  &#xD;
            -  Severe chronic obstructive pulmonary disease;&#xD;
  &#xD;
            -  Uncontrolled hypertension;&#xD;
  &#xD;
            -  Symptomatic peripheral arterial disease;&#xD;
  &#xD;
            -  Unstable angina;&#xD;
  &#xD;
            -  Uncontrolled diabetes;&#xD;
  &#xD;
            -  Acute pulmonary oedema in the last 12 hours;&#xD;
  &#xD;
            -  Those who refuse to participate.&#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_contact>
      <last_name>José Moreira</last_name>
      <phone>+351 266 730 300</phone>
      <email>jose.moreira@uevora.pt</email>
    </overall_contact>
    <location>
      <facility>
        <name>National School of Public Health</name>
        <address>
          <city>Lisbon</city>
          <country>Portugal</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>José Moreira</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Portugal</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Évora</investigator_affiliation>
      <investigator_full_name>José Manuel Afonso Moreira</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06032013
  org study id: National School Public Health
  nct id: NCT06032013
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Cardiac Rehabilitation (CR) programs are a multidisciplinary process aimed at patient
        recovery after an acute cardiovascular event or with chronic heart disease, reducing
        mortality and morbidity, optimising functional capacity and improving quality of life. The
        aim is to maintain or recover the patient's clinical, physical and psychosocial condition,
        slowing down or halting the progression of the underlying disease process. It is based on the
        practice of personalized physical exercise and the adaptation of behaviours towards a
        healthier lifestyle, ensuring the reduction and control of risk factors. It is considered a
        cost-effective intervention that is explicitly and formally recommended by the most diverse
        and important scientific societies. Through the partnership and collaboration between the
        various health institutions and the academy, the CR program will take place on an outpatient
        basis, in a supervised manner, starting after risk stratification with a stress test and
        respective clinical assessment by a cardiologist. The coordinator of the CR program will be a
        cardiologist, and the entire multidisciplinary team will be responsible for effectiveness and
        safety, as well as patient assessment and progress.
  The outpatient CR program is designed for a group of participants who have had a cardiac
        event, based on the American College of Sports Medicine's Guidelines for Exercise Testing and
        Prescription, consisting of two exercise sessions/week. The sessions are supervised by a
        healthcare professional specialising in cardiac rehabilitation, and the participant's
        haemodynamic status is monitored continuously using scales and electronic equipment. PROMs
        will be applied before and after the program.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: EQ5D-5L: Health-related quality of life
  time frame: Before the intervention and up to 8 weeks.
  description: The EQ5D makes it possible to assess quality of life in a given pathology in the general population, presented in different domains. The visual analogue scale of this questionnaire has a score of 0-100. Higher scores mean a better result.
  measure: HADS: Anxiety and depression
  time frame: Before the intervention and up to 8 weeks.
  description: Participants' anxiety and worries are also assessed. Mood disorders, weakness, worry, stress, and depression are common psychological repercussions for patients after a cardiac event, which can trigger hyperventilation reactions. This type of common reaction to emotional extremes such as fear, anxiety, or stress in participants can have a direct impact on involvement in CR programs. This questionnaire is made up of 14 questions. Lower scores mean a better result.
  measure: Heart rate
  time frame: Before, during and up to 8 weeks of the program.
  description: Heart rate (bpm)
  measure: Blood pressure
  time frame: Before, during and up to 8 weeks of the program.
  description: Blood pressure (mmHg)
  measure: Peripheral oxygen saturation
  time frame: Before, during and up to 8 weeks of the program.
  description: Peripheral oxygen saturation (%)
  measure: Exercise Capacity
  time frame: During and up to 8 weeks of the program.
  description: Borg scale- score 0-10. Higher values mean greater respiratory effort.
  measure: Weight
  time frame: Before the intervention and up to 8 weeks.
  description: Weight (Kg)
  measure: Abdominal perimeter
  time frame: Before the intervention and up to 8 weeks.
  description: Abdominal perimeter (cm)
  arm group label: Cardiac Rehabilitation intervention
  arm group type: Experimental
  description: Outpatient intervention with participants after a cardiac event who fulfil the inclusion criteria.
  intervention type: Other
  intervention name: Cardiac rehabilitation program (PROMs)
  description: The program is multidisciplinary with the following components:
  Medical assessment
  Physical training and counselling on physical activity
  Identification and control of risk factors
  Nutritional assessment and counselling
  Psychological assessment and intervention
  Education and information
  arm group label: Cardiac Rehabilitation intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: José Moreira
  phone: +351 266 730 300
  email: jose.moreira@uevora.pt
  facility: 
  status: Recruiting
  contact: 
  country: Portugal
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Évora
  investigator full name: José Manuel Afonso Moreira
  investigator title: Principal Investigator
  sharing ipd: No