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/NCT06029556</url>
    </required_header>
    <id_info>
      <org_study_id>REC/01373 Sarmad</org_study_id>
      <nct_id>NCT06029556</nct_id>
    </id_info>
    <brief_title>Effects of Early Mobility Protocols in Cardiac ICU</brief_title>
    <official_title>Effects of Early Mobilization on Functional Capacity, Physical Activity and Kinesiophobia in Post Coronary Artery Bypass Grafting</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</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>
        In this study the investigator aim to find the effects of early mobility on different&#xD;
        physical activity protocols in post CABG patients. Physical activity, functional status,&#xD;
        functional capacity, Kinesiophobia, ICU mortality, heart rate, blood pressure, oxygen&#xD;
        saturation, length of hospital stay and sternal instability. To compare the physical activity&#xD;
        protocol used by physical therapist.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Current study will compare two different early mobility protocols and will help in assessing&#xD;
        best protocol to be use in cardiac ICU for better outcomes of patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Functional Status score Questionnaire</measure>
      <time_frame>Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)</time_frame>
      <description>Five item scale measures the physical performance of patients in ICU.The Functional Status Score for the Intensive Care Unit (FSS-ICU) is a 5-item performance-based measure that utilizes an 8 point, ordinal scale to measure physical function for patients in the intensive care unit setting.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>BAECK PHYSICAL ACTIVITY QUESTIONNAIRE</measure>
      <time_frame>Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)</time_frame>
      <description>Evaluates the physical activity over the past 12 months. The MBPAQ (BHPAQ) evaluates habitual physical activities in individuals. Activities are scored on a scale of 1-5. A score of 5 indicates the most activity and 1 indicates the least activity for each index.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6 minute walk Test</measure>
      <time_frame>Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)</time_frame>
      <description>Sub-maximal test evaluates the aerobic endurance. The 6-minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tampa Scale of Kinesiophobia</measure>
      <time_frame>Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)</time_frame>
      <description>Evaluate the fear of movement during activity ,17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. Changes will be measured at baseline and at completion of 4th week</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>STERNAL INSTABILITY SCALE:</measure>
      <time_frame>Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)</time_frame>
      <description>The sternal instability scale (SIS) is a non-invasive manual assessment tool used to detect early bony non-union or instability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BORG RATING OF PERCEIVED EXERTION</measure>
      <time_frame>Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)</time_frame>
      <description>The Borg RPE Scale is a 15-point scale (6 to 20) used to rate subjective experiences during physical exertion. This subjective load scale can help estimate load symptoms, such as the degree of exertion, the degree of load and fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of Hospital stay</measure>
      <time_frame>Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)</time_frame>
      <description>Total number of days stay in hospital average of days in both group.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>CABG</condition>
    <arm_group>
      <arm_group_label>Mobility out of Bed</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Ergometry in Bed</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mobility out of Bed</intervention_name>
      <description>Active upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conduct on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low-intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned</description>
      <arm_group_label>Ergometry in Bed</arm_group_label>
      <arm_group_label>Mobility out of Bed</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ergometry in Bed</intervention_name>
      <description>Ankle pumps (5*2), knee extension (5*2), breathing exercises with elbow flexion and extension(5*2), spirometry and progressive early ambulation (from bed to wheelchair and wheelchair to standing and from standing to few steps), and conventional chest physical activity (5 minutes on precursor)</description>
      <arm_group_label>Ergometry in Bed</arm_group_label>
      <arm_group_label>Mobility out of Bed</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 40-70 years&#xD;
  &#xD;
            -  Both Genders&#xD;
  &#xD;
            -  Extubated patients with no Complication&#xD;
  &#xD;
            -  Post CABG (Elective)&#xD;
  &#xD;
            -  Vitally stable&#xD;
  &#xD;
            -  1st CABG&#xD;
  &#xD;
            -  Selective CABG surgeries&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Post anesthesia Psychosis&#xD;
  &#xD;
            -  Corrective surgeries&#xD;
  &#xD;
            -  Post CABG Stroke&#xD;
  &#xD;
            -  Infectious wound&#xD;
  &#xD;
            -  Participants with a physical disability&#xD;
  &#xD;
            -  Intra-aortic balloon pump (IABP)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sumaiyah Obaid, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sumaiyah Obaid, MS</last_name>
      <phone>+923212683462</phone>
      <email>sumaiyah.obaid@riphah.edu.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sarmad Khattak, DPT</last_name>
      <phone>+923428578356</phone>
      <email>sarmadkhattak007@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rehman Medical Institute</name>
        <address>
          <city>Peshawar</city>
          <state>KPK</state>
          <zip>25000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>December 6, 2022</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Early mobility</keyword>
    <keyword>Physical activity</keyword>
    <keyword>Kinesiophobia</keyword>
    <keyword>Functional capacity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kinesiophobia</mesh_term>
    </condition_browse>
    <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/NCT06029556
  org study id: REC/01373 Sarmad
  nct id: NCT06029556
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In this study the investigator aim to find the effects of early mobility on different
        physical activity protocols in post CABG patients. Physical activity, functional status,
        functional capacity, Kinesiophobia, ICU mortality, heart rate, blood pressure, oxygen
        saturation, length of hospital stay and sternal instability. To compare the physical activity
        protocol used by physical therapist.
  Current study will compare two different early mobility protocols and will help in assessing
        best protocol to be use in cardiac ICU for better outcomes of patients.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Functional Status score Questionnaire
  time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
  description: Five item scale measures the physical performance of patients in ICU.The Functional Status Score for the Intensive Care Unit (FSS-ICU) is a 5-item performance-based measure that utilizes an 8 point, ordinal scale to measure physical function for patients in the intensive care unit setting.
  measure: BAECK PHYSICAL ACTIVITY QUESTIONNAIRE
  time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
  description: Evaluates the physical activity over the past 12 months. The MBPAQ (BHPAQ) evaluates habitual physical activities in individuals. Activities are scored on a scale of 1-5. A score of 5 indicates the most activity and 1 indicates the least activity for each index.
  measure: 6 minute walk Test
  time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
  description: Sub-maximal test evaluates the aerobic endurance. The 6-minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
  measure: Tampa Scale of Kinesiophobia
  time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
  description: Evaluate the fear of movement during activity ,17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. Changes will be measured at baseline and at completion of 4th week
  measure: STERNAL INSTABILITY SCALE:
  time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
  description: The sternal instability scale (SIS) is a non-invasive manual assessment tool used to detect early bony non-union or instability.
  measure: BORG RATING OF PERCEIVED EXERTION
  time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
  description: The Borg RPE Scale is a 15-point scale (6 to 20) used to rate subjective experiences during physical exertion. This subjective load scale can help estimate load symptoms, such as the degree of exertion, the degree of load and fatigue.
  measure: Length of Hospital stay
  time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
  description: Total number of days stay in hospital average of days in both group.
  arm group label: Mobility out of Bed
  arm group type: Active Comparator
  arm group label: Ergometry in Bed
  arm group type: Experimental
  intervention type: Other
  intervention name: Mobility out of Bed
  description: Active upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conduct on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low-intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned
  arm group label: Ergometry in Bed
  arm group label: Mobility out of Bed
  intervention type: Other
  intervention name: Ergometry in Bed
  description: Ankle pumps (5*2), knee extension (5*2), breathing exercises with elbow flexion and extension(5*2), spirometry and progressive early ambulation (from bed to wheelchair and wheelchair to standing and from standing to few steps), and conventional chest physical activity (5 minutes on precursor)
  arm group label: Ergometry in Bed
  arm group label: Mobility out of Bed
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Sumaiyah Obaid, MS
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Sumaiyah Obaid, MS
  phone: +923212683462
  email: sumaiyah.obaid@riphah.edu.pk
  last name: Sarmad Khattak, DPT
  phone: +923428578356
  email: sarmadkhattak007@gmail.com
  facility: 
  status: Recruiting
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Kinesiophobia
  sharing ipd: No