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/NCT06012396</url>
    </required_header>
    <id_info>
      <org_study_id>PNUYH_ETRI_3</org_study_id>
      <nct_id>NCT06012396</nct_id>
    </id_info>
    <brief_title>Community-based Complex Exercise for Stroke Patients</brief_title>
    <acronym>COB-CEPS</acronym>
    <official_title>Safety and Validation of Community Rehabilitation Exercise Program for Stroke Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pusan National University Yangsan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pusan National University Yangsan Hospital</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>
        A lot of physical and social effects of exercise programs and daily physical education have&#xD;
        already been proven for stroke patients after discharge. However, stroke patients have shown&#xD;
        a passive attitude in participating in physical education or exercise programs for life, and&#xD;
        the local community lacked appropriate guidelines or experience in guiding exercise and&#xD;
        physical education for stroke patients, so they had a burden on instructing exercise. In this&#xD;
        study, an appropriate complex exercise program was established for patients after discharge&#xD;
        through analysis of domestic and foreign research data to provide an environment and&#xD;
        opportunity to exercise in the community, and based on the results, stroke patients actively&#xD;
        exercise in the community in the future. The goal is to provide a basis for doing so.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 6, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 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>Parallel Assignment</intervention_model>
      <intervention_model_description>rct</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>6WMT</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>MRS</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability The scale runs from 0-6, running from perfect health without symptoms to death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BBS</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Berg balance scale (0-56, the higher the better) Objectively determine a patient's ability to safely balance during a series of predetermined tasks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FAC</measure>
      <time_frame>visit 1, visit 23</time_frame>
      <description>Functional ambulation category (0-5, the higher the better) 6-point functional walking test that evaluates ambulation ability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MMT</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Manual Muscle Testing (MMT) is a technique used in physical therapy and rehabilitation to assess the strength and function of individual muscles or muscle groups. It involves the application of specific resistance against the muscle's movement to determine its ability to generate force.&#xD;
  This technique includes assessing major muscles from the upper and lower limbs opposing the therapist's force and grading the patient's muscle strength on a 0 to 5 scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TUG</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Timed up and go To determine fall risk and measure the progress of balance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Grip Strength</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Grip strength measure of muscular strength or the maximum force/tension generated by one's forearm muscles</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Percentage of fat, bone, and muscle in the body</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>International Physical Activity Questionnaire (No scores) 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better) A brief and simple instrument measuring health related quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GDS</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Getriatic depression scale (0-15, the higher the more depressive) Assessment of depression in the elderly</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sit to stand</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Recording the number of times sitting and rising for 30 seconds by measuring the strength of the lower extremities of the elderly</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>flexibility test</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Measure the length beyond the tip of the toes with the hand stretched out in a seated forward bending position.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>coordination test</measure>
      <time_frame>Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)</time_frame>
      <description>Assessment of Coordination Measures in Older Adults. Draw a rectangle with a width of 3.6m and a length of 1.6m, place a chair at a point 2.4m from the center in both corners, and measure the time to return to the left and right rear corners twice in 0.1 second units</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">126</enrollment>
    <condition>Stroke</condition>
    <condition>Exercise</condition>
    <arm_group>
      <arm_group_label>Exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Daily life group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Stoke complex exercise program</intervention_name>
      <description>warm-up(5min) flexibility exercise - neck, triceps brachii, biceps brachii, forearm, back, quadriceps, biceps femoris, ankle&#xD;
  main exercise(40min) aerobic exercise(20min)- use stepper, treadmill, high intensity HRR60%, RPE 11~14 low intensity HRR30%, RPE 9~11 repeated interval training strength and balance exercises(20min)- program1. upper(shoulder press, chest press, biceps curl), lower(hip flexion, knee extension), Core(plank exercise, sit up) program2. upper(seated back row, triceps extension), lower(hip extension, hip abduction, knee flexion, Core(superman exercise, bridge exercise) repeated ever other day program1, program2 clean-up(5min) - same as warm-up</description>
      <arm_group_label>Exercise group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Stroke patients aged 30 years or older residing in the community&#xD;
  &#xD;
            -  Those who can walk independently and have a score of 3 or higher in the Functional&#xD;
               Ambulation Category (FAC)&#xD;
  &#xD;
            -  The daily life dependence of the stroke patient is a person who can perform simple&#xD;
               tasks necessary for daily life, Those who scored 2 points or less on the Modified&#xD;
               Rankin Scale (mRS)&#xD;
  &#xD;
            -  Subjects with no or mild stiffness of the affected upper and lower limbs, with a score&#xD;
               of 1 or less on the Modified Ashworth Scale (MAS)&#xD;
  &#xD;
            -  All 3 major joints of the affected upper and lower limbs (Manual Muscle Test (MMT))&#xD;
               are 3 points (F grade) or higher ruler&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  With moderate or severe cognitive dysfunction, Korean-Mini Mental state test&#xD;
               (Korean-Mini Mental state test) Those who scored less than 18 points in the&#xD;
               Examination (K-MMSE)&#xD;
  &#xD;
            -  A person with a moderate or higher fall risk and less than 41 points on the Berg&#xD;
               Balance Scale (BBS)&#xD;
  &#xD;
            -  Those who have difficulty understanding the intervention exercise program or&#xD;
               expressing symptoms due to severe language impairment&#xD;
  &#xD;
            -  Those who cannot apply this intervention exercise program due to serious&#xD;
               cardiovascular disease&#xD;
  &#xD;
            -  Those who have musculoskeletal disorders that make it impossible to exercise&#xD;
  &#xD;
            -  Those who are judged unsuitable for this study under the judgment of a specialist in&#xD;
               rehabilitation medicine due to other diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>JUNGLIM LEE</last_name>
      <phone>82+ 1049147899</phone>
      <phone_ext>82+ 0553604152</phone_ext>
      <email>lim6668@naver.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Pusan National University Yangsan Hospital</name>
        <address>
          <city>Yangsan</city>
          <state>Gyeongnam</state>
          <zip>50612</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sung-Hwa Ko, PhD</last_name>
        <phone>+82-10-9344-4117</phone>
        <email>ijsh6679@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pusan National University Yangsan Hospital</investigator_affiliation>
      <investigator_full_name>Sung-Hwa Ko</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>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06012396
  org study id: PNUYH_ETRI_3
  nct id: NCT06012396
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A lot of physical and social effects of exercise programs and daily physical education have
        already been proven for stroke patients after discharge. However, stroke patients have shown
        a passive attitude in participating in physical education or exercise programs for life, and
        the local community lacked appropriate guidelines or experience in guiding exercise and
        physical education for stroke patients, so they had a burden on instructing exercise. In this
        study, an appropriate complex exercise program was established for patients after discharge
        through analysis of domestic and foreign research data to provide an environment and
        opportunity to exercise in the community, and based on the results, stroke patients actively
        exercise in the community in the future. The goal is to provide a basis for doing so.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: rct
  primary purpose: Treatment
  masking: Single (Participant)
  measure: 6WMT
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: 6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
  measure: MRS
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability The scale runs from 0-6, running from perfect health without symptoms to death.
  measure: BBS
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Berg balance scale (0-56, the higher the better) Objectively determine a patient's ability to safely balance during a series of predetermined tasks
  measure: FAC
  time frame: visit 1, visit 23
  description: Functional ambulation category (0-5, the higher the better) 6-point functional walking test that evaluates ambulation ability
  measure: MMT
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Manual Muscle Testing (MMT) is a technique used in physical therapy and rehabilitation to assess the strength and function of individual muscles or muscle groups. It involves the application of specific resistance against the muscle's movement to determine its ability to generate force.
  This technique includes assessing major muscles from the upper and lower limbs opposing the therapist's force and grading the patient's muscle strength on a 0 to 5 scale
  measure: TUG
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Timed up and go To determine fall risk and measure the progress of balance
  measure: Grip Strength
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Grip strength measure of muscular strength or the maximum force/tension generated by one's forearm muscles
  measure: Body composition
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Percentage of fat, bone, and muscle in the body
  measure: Physical activity
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: International Physical Activity Questionnaire (No scores) 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old
  measure: EQ-5D
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better) A brief and simple instrument measuring health related quality of life
  measure: GDS
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Getriatic depression scale (0-15, the higher the more depressive) Assessment of depression in the elderly
  measure: sit to stand
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Recording the number of times sitting and rising for 30 seconds by measuring the strength of the lower extremities of the elderly
  measure: flexibility test
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Measure the length beyond the tip of the toes with the hand stretched out in a seated forward bending position.
  measure: coordination test
  time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
  description: Assessment of Coordination Measures in Older Adults. Draw a rectangle with a width of 3.6m and a length of 1.6m, place a chair at a point 2.4m from the center in both corners, and measure the time to return to the left and right rear corners twice in 0.1 second units
  arm group label: Exercise group
  arm group type: Experimental
  arm group label: Daily life group
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Stoke complex exercise program
  description: warm-up(5min) flexibility exercise - neck, triceps brachii, biceps brachii, forearm, back, quadriceps, biceps femoris, ankle
  main exercise(40min) aerobic exercise(20min)- use stepper, treadmill, high intensity HRR60%, RPE 11~14 low intensity HRR30%, RPE 9~11 repeated interval training strength and balance exercises(20min)- program1. upper(shoulder press, chest press, biceps curl), lower(hip flexion, knee extension), Core(plank exercise, sit up) program2. upper(seated back row, triceps extension), lower(hip extension, hip abduction, knee flexion, Core(superman exercise, bridge exercise) repeated ever other day program1, program2 clean-up(5min) - same as warm-up
  arm group label: Exercise group
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: N/A
  healthy volunteers: No
  last name: JUNGLIM LEE
  phone: 82+ 1049147899
  phone ext: 82+ 0553604152
  email: lim6668@naver.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Pusan National University Yangsan Hospital
  investigator full name: Sung-Hwa Ko
  investigator title: Professor
  mesh term: Stroke
  sharing ipd: Undecided