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/NCT06013605</url>
    </required_header>
    <id_info>
      <org_study_id>DP.04.03/KEP064/EC043/2023</org_study_id>
      <nct_id>NCT06013605</nct_id>
    </id_info>
    <brief_title>Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft</brief_title>
    <official_title>Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indonesia University</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>
        The goal of this clinical trial is to assess the effect of walking exercise on functional&#xD;
        capacity and productivity in patients after Coronary Artery Bypass Graft who have completed&#xD;
        phase II cardiac rehabilitation. The main question it aims to answer are:&#xD;
  &#xD;
        1. What is the effect of walking exercise on functional capacity and productivity in patients&#xD;
        after Coronary Artery Bypass Graft? Participants performed the exercise on the day agreed&#xD;
        upon with the researcher. Respondents did walking exercises 3 times per week for 4 weeks with&#xD;
        a duration of 10 minutes of warm-up, 30 minutes of walking exercises, and 10 minutes of&#xD;
        cooling down. Respondents also did leg straightening every day for 4 weeks with a frequency&#xD;
        of 1 time a day for 10 minutes. Researchers compared between intervention and control group&#xD;
        to see if the effect between respondents who did walking and leg straightening exercises and&#xD;
        also respondents who only did leg straightening.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research process was guided by The Consort Statement for RCT research. The process was&#xD;
        conducted through the stages of enrollment, allocation, follow-up, and analysis. The&#xD;
        recruitment process begins with an eligibility assessment process for potential respondents.&#xD;
        This process was carried out when the patient conducted a phase 2 cardiac rehabilitation&#xD;
        evaluation. Researchers initially checked patient data through medical records by looking at&#xD;
        color codes (pink indicates Coronary Artery Bypass Graft patients), age, and location of&#xD;
        residence. The patient's communication skills were observed during the evaluation process.&#xD;
        The doctor determines the patient's risk stratification after the evaluation, then the&#xD;
        researcher sees the patient's risk stratification from the assessment results in the medical&#xD;
        record. The inclusion criteria in this study were patients aged 18-60 years, working, having&#xD;
        mild to moderate risk stratification, living in the Jakarta, Bogor, Depok, Tangerang and&#xD;
        Bekasi areas, and patients who could communicate well. Respondents who had been collected&#xD;
        were then randomized using an envelope so that the respondents were divided into 2 groups&#xD;
        where 21 respondents entered the intervention group and 21 respondents entered the control&#xD;
        group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 26, 2023</start_date>
    <completion_date type="Actual">July 7, 2023</completion_date>
    <primary_completion_date type="Actual">July 7, 2023</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>
      <intervention_model_description>This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcome assessors were not involved during the intervention process. Respondents were also asked not to inform the outcome assessor of the measures they received.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Functional Capacity</measure>
      <time_frame>6 minutes</time_frame>
      <description>The ability of post-CABG patients to be able to perform expected activities or workloads can be done using the 6 Minutes Walking Test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Productivity</measure>
      <time_frame>5 minutes</time_frame>
      <description>The ability of post-CABG patients to perform work and physical activities was assessed using the WPAI.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">42</enrollment>
    <condition>Coronary Artery Bypass</condition>
    <condition>Cardiac Rehabilitation</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants did walking exercise and usual care (leg straightening)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants did usual care (leg straightening)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Walking Exercise and Leg Straightening</intervention_name>
      <description>Participants performed the exercise on the day agreed upon with the researcher. Respondents did walking exercises 3 times per week for 4 weeks with a duration of 10 minutes of warm-up, 30 minutes of walking exercises, and 10 minutes of cooling down. Respondents also did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Leg Straightening</intervention_name>
      <description>Respondents did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Post- CABG patients in phase III of cardiac rehabilitation;&#xD;
  &#xD;
            -  Patients living in the JaBoDeTaBek area;&#xD;
  &#xD;
            -  Patients aged 18 - 60 years;&#xD;
  &#xD;
            -  Patients who have mild to moderate risk stratification;&#xD;
  &#xD;
            -  Patients who do not have limitations in mobilization such as using mobility aids&#xD;
               (wheelchairs, walkers, crutches);&#xD;
  &#xD;
            -  Patients who do not perform routine aerobic exercise based on time intervals and types&#xD;
               of exercise (such as cardiac exercise, cycling, ergocycle, etc.);&#xD;
  &#xD;
            -  Patients can communicate well and are willing to become respondents by signing&#xD;
               informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with conditions that contraindicate exercise or rehabilitation such as&#xD;
               unstable angina pectoris, resting systolic blood pressure &gt;200 mmHg or diastolic &gt;110&#xD;
               mmHg, clinical aortic valve stenosis, acute systemic disease, uncontrolled atrial or&#xD;
               ventricular dysrhythmias, uncontrolled sinus tachycardia, uncompensated heart failure,&#xD;
               third-degree atrioventricular block without pacing, active pericarditis or&#xD;
               myocarditis, pulmonary thromboembolism, depression or ST-segment elevation at rest,&#xD;
               Diabetic Mellitus with uncontrolled blood sugar, thyroiditis, hypokalemia,&#xD;
               hyperkalemia, hypovolemia.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Indra G Pamungkas</last_name>
      <role>Study Chair</role>
      <affiliation>Indonesia University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Cardiovascular Center Harapan Kita</name>
        <address>
          <city>Jakarta</city>
          <state>DKI Jakarta</state>
          <zip>11420</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Indra Gilang Pamungkas</investigator_full_name>
      <investigator_title>Ns. Indra Gilang Pamungkas, S.Kep., M.Kep</investigator_title>
    </responsible_party>
    <keyword>Coronary Artery Bypass</keyword>
    <keyword>Walking</keyword>
    <keyword>Functional Capacity</keyword>
    <keyword>Productivity</keyword>
    <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/NCT06013605
  org study id: DP.04.03/KEP064/EC043/2023
  nct id: NCT06013605
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to assess the effect of walking exercise on functional
        capacity and productivity in patients after Coronary Artery Bypass Graft who have completed
        phase II cardiac rehabilitation. The main question it aims to answer are:
  
        1. What is the effect of walking exercise on functional capacity and productivity in patients
        after Coronary Artery Bypass Graft? Participants performed the exercise on the day agreed
        upon with the researcher. Respondents did walking exercises 3 times per week for 4 weeks with
        a duration of 10 minutes of warm-up, 30 minutes of walking exercises, and 10 minutes of
        cooling down. Respondents also did leg straightening every day for 4 weeks with a frequency
        of 1 time a day for 10 minutes. Researchers compared between intervention and control group
        to see if the effect between respondents who did walking and leg straightening exercises and
        also respondents who only did leg straightening.
  The research process was guided by The Consort Statement for RCT research. The process was
        conducted through the stages of enrollment, allocation, follow-up, and analysis. The
        recruitment process begins with an eligibility assessment process for potential respondents.
        This process was carried out when the patient conducted a phase 2 cardiac rehabilitation
        evaluation. Researchers initially checked patient data through medical records by looking at
        color codes (pink indicates Coronary Artery Bypass Graft patients), age, and location of
        residence. The patient's communication skills were observed during the evaluation process.
        The doctor determines the patient's risk stratification after the evaluation, then the
        researcher sees the patient's risk stratification from the assessment results in the medical
        record. The inclusion criteria in this study were patients aged 18-60 years, working, having
        mild to moderate risk stratification, living in the Jakarta, Bogor, Depok, Tangerang and
        Bekasi areas, and patients who could communicate well. Respondents who had been collected
        were then randomized using an envelope so that the respondents were divided into 2 groups
        where 21 respondents entered the intervention group and 21 respondents entered the control
        group.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Outcome assessors were not involved during the intervention process. Respondents were also asked not to inform the outcome assessor of the measures they received.
  measure: Functional Capacity
  time frame: 6 minutes
  description: The ability of post-CABG patients to be able to perform expected activities or workloads can be done using the 6 Minutes Walking Test.
  measure: Productivity
  time frame: 5 minutes
  description: The ability of post-CABG patients to perform work and physical activities was assessed using the WPAI.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Participants did walking exercise and usual care (leg straightening)
  arm group label: Control Group
  arm group type: Experimental
  description: Participants did usual care (leg straightening)
  intervention type: Behavioral
  intervention name: Walking Exercise and Leg Straightening
  description: Participants performed the exercise on the day agreed upon with the researcher. Respondents did walking exercises 3 times per week for 4 weeks with a duration of 10 minutes of warm-up, 30 minutes of walking exercises, and 10 minutes of cooling down. Respondents also did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes.
  arm group label: Intervention Group
  intervention type: Behavioral
  intervention name: Leg Straightening
  description: Respondents did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Indra G Pamungkas
  role: Study Chair
  affiliation: Indonesia University
  facility: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: Indra Gilang Pamungkas
  investigator title: Ns. Indra Gilang Pamungkas, S.Kep., M.Kep
  sharing ipd: No