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/NCT05980351</url>
    </required_header>
    <id_info>
      <org_study_id>Exercise on QOL and stress</org_study_id>
      <nct_id>NCT05980351</nct_id>
    </id_info>
    <brief_title>Exercise Program on Quality of Life and Stress in Children Undergoing Hemodialysis</brief_title>
    <official_title>Effect of Exercise Program on Quality of Life and Stress in Children Undergoing Hemodialysis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Despite the benefits of physical exercises among children with chronic illness, the children&#xD;
        avoid to engage in different physical activities because their parent and the child also were&#xD;
        faired to happen any complication to child. The lack of activity and sedentary life style&#xD;
        among these children result in reduced quality of life in addition to behavioral and social&#xD;
        problems and finally become independent in most of activities of daily living. Therefore, the&#xD;
        primary aim of this study will to practice and teach the children exercise programs in order&#xD;
        to improve the quality of life and reduce stress in children undergoing hemodialysis.&#xD;
        Therefore aim of this study is to: Determine the effect of exercise program on quality of&#xD;
        life and stress in children undergoing hemodialysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  The researcher will go to hospital and will take all children that present in&#xD;
             hemodialysis unit, then will make random assignment of children to study or control&#xD;
             group .The control group will receive routine care while the study group will receive&#xD;
             exercise program.&#xD;
  &#xD;
          -  The exercise program will conduct three days per week giving an interval of 24 hours&#xD;
             between sessions. In the first hour the child not make any activity, then first 20 min&#xD;
             from second hour of hemodialysis the child will receive stretching exercise, first 20&#xD;
             min from third hour the child will receive range of motion exercise finally first 20 min&#xD;
             from forth hour the child will practice isometric exercise.&#xD;
  &#xD;
          -  This procedure will continue for 2 months and the end of time the research will make&#xD;
             posttest for both groups. The intensity for resistance training will determined&#xD;
             individually. Depending up on the child exercise tolerance, each set will performed 10&#xD;
             gradually increase to 15 repetitions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Children Quality Of Life</measure>
      <time_frame>After 2 months</time_frame>
      <description>Health Related Quality Of Life (HRQOL): Will use to measure children quality of life which includes the four domains (physical, emotional, social and school performance), each domain consists of 5 questions. Each question will earn score from (0-4) according to their answer as the following:&#xD;
  4 means= never have a problem 3 means= almost never a problem 2 means= sometimes a problem&#xD;
  1 means= it is often a problem 0 means = almost always a problem</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stress</measure>
      <time_frame>After 2 months</time_frame>
      <description>Tool (3): Perceived Stress Scale The Perceived Stress Scale (PSS) is a classic stress assessment instrument. This tool, helping the investigators to understands how different situations affect participants feelings and perceived stress. The questions in this scale ask about participants feelings and thoughts. In each case, the child will be asked to indicate how often felt or thought a certain way.&#xD;
  This scale consisted of 10 questions; each question will earn score from (0-4) according to their answer as the following:&#xD;
  4 means= very often 3 means= fairly often 2 means= sometimes&#xD;
  1 means= almost never 0 means = never Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.&#xD;
  Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive exercise program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will receive routine hospital care</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise</intervention_name>
      <description>The children will receive exercise program(stretching exercise,range of motion exercise and isometric exercise)</description>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children aged from 6-18years with chronic renal failure.&#xD;
  &#xD;
                 -  All children are stable on dialysis for 2 months (Blood pressure under medical&#xD;
                    control and stable blood sugar).&#xD;
  &#xD;
                 -  All children are free from lower extremity graft and any lower limb pathology.&#xD;
  &#xD;
                 -  Children do not take exercise in 6 months before treatment.&#xD;
  &#xD;
                 -  Willing to participate in the study and attend the exercise schedule.&#xD;
  &#xD;
                 -  Children able to follow verbal commands.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with physical disabilities.&#xD;
  &#xD;
            -  Children on tranquilizers or sedative medications.&#xD;
  &#xD;
            -  Children with a femoral dialysis catheter&amp; internal jugular vein catheter&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shimaa Hassan Khalf allah, PHD</last_name>
      <phone>01097248758</phone>
      <email>shimaa_hassan@aun.edu.eg</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Shimaa Hassan Khalf allah</investigator_full_name>
      <investigator_title>Assistant lecturer</investigator_title>
    </responsible_party>
    <keyword>Exercise</keyword>
    <keyword>Quality of Life</keyword>
    <keyword>Stress</keyword>
    <keyword>Hemodialysis children</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/NCT05980351
  org study id: Exercise on QOL and stress
  nct id: NCT05980351
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Despite the benefits of physical exercises among children with chronic illness, the children
        avoid to engage in different physical activities because their parent and the child also were
        faired to happen any complication to child. The lack of activity and sedentary life style
        among these children result in reduced quality of life in addition to behavioral and social
        problems and finally become independent in most of activities of daily living. Therefore, the
        primary aim of this study will to practice and teach the children exercise programs in order
        to improve the quality of life and reduce stress in children undergoing hemodialysis.
        Therefore aim of this study is to: Determine the effect of exercise program on quality of
        life and stress in children undergoing hemodialysis.
  -  The researcher will go to hospital and will take all children that present in
             hemodialysis unit, then will make random assignment of children to study or control
             group .The control group will receive routine care while the study group will receive
             exercise program.
  
          -  The exercise program will conduct three days per week giving an interval of 24 hours
             between sessions. In the first hour the child not make any activity, then first 20 min
             from second hour of hemodialysis the child will receive stretching exercise, first 20
             min from third hour the child will receive range of motion exercise finally first 20 min
             from forth hour the child will practice isometric exercise.
  
          -  This procedure will continue for 2 months and the end of time the research will make
             posttest for both groups. The intensity for resistance training will determined
             individually. Depending up on the child exercise tolerance, each set will performed 10
             gradually increase to 15 repetitions.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Children Quality Of Life
  time frame: After 2 months
  description: Health Related Quality Of Life (HRQOL): Will use to measure children quality of life which includes the four domains (physical, emotional, social and school performance), each domain consists of 5 questions. Each question will earn score from (0-4) according to their answer as the following:
  4 means= never have a problem 3 means= almost never a problem 2 means= sometimes a problem
  1 means= it is often a problem 0 means = almost always a problem
  measure: Stress
  time frame: After 2 months
  description: Tool (3): Perceived Stress Scale The Perceived Stress Scale (PSS) is a classic stress assessment instrument. This tool, helping the investigators to understands how different situations affect participants feelings and perceived stress. The questions in this scale ask about participants feelings and thoughts. In each case, the child will be asked to indicate how often felt or thought a certain way.
  This scale consisted of 10 questions; each question will earn score from (0-4) according to their answer as the following:
  4 means= very often 3 means= fairly often 2 means= sometimes
  1 means= almost never 0 means = never Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
  Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
  arm group label: Study group
  arm group type: Experimental
  description: This group will receive exercise program
  arm group label: Control group
  arm group type: No Intervention
  description: This group will receive routine hospital care
  intervention type: Other
  intervention name: exercise
  description: The children will receive exercise program(stretching exercise,range of motion exercise and isometric exercise)
  arm group label: Study group
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Shimaa Hassan Khalf allah, PHD
  phone: 01097248758
  email: shimaa_hassan@aun.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Shimaa Hassan Khalf allah
  investigator title: Assistant lecturer
  sharing ipd: No