<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/NCT01666015</url>
  </required_header>
  <id_info>
    <org_study_id>RF-CACICPES01</org_study_id>
    <secondary_id>University of Calgary</secondary_id>
    <nct_id>NCT01666015</nct_id>
  </id_info>
  <brief_title>Exercise in Pediatric Autologous Stem Cell Transplant Patients</brief_title>
  <acronym>SCORE</acronym>
  <official_title>Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship&#xD;
      and cure various oncologic diseases. However, this therapy is associated with high mortality&#xD;
      rates and numerous negative side-effects. The recovery of the immune system is a special&#xD;
      concern and plays a key role in the success of this treatment. In healthy populations it is&#xD;
      known that exercise plays an important role in immune system regulation, but little is known&#xD;
      about the role of exercise in the hematological and immunological recovery of children&#xD;
      undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized&#xD;
      Controlled Trial is: study the effect of an exercise program on immune cell recovery in&#xD;
      patients undergoing autologous stem cell transplantation. The Secondary objective is to&#xD;
      determine if an exercise intervention might diminish the deterioration of quality of life,&#xD;
      physical fitness, and the acquisition of a sedentary lifestyle.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to&#xD;
      18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or&#xD;
      control group. The exercise group will participate in a two-phase exercise intervention (in&#xD;
      and outpatient) from hospitalization until 10 weeks after discharge. The exercise program&#xD;
      includes strength, flexibility and aerobic exercise. During the inpatient phase this program&#xD;
      will be performed 5 times/week and will be supervised. The outpatient phase will combine a&#xD;
      supervised session with two home-based exercise sessions with the use of the Wii device. The&#xD;
      control group will follow the standard protocol without any specific exercise program. A&#xD;
      range of outcomes, including quantitative and functional recovery of immune system, cytokine&#xD;
      levels in serum, NK cells and their subset recovery and function, and gene expression of&#xD;
      activating and inhibitory NK cell receptors, body composition, nutrition, quality of life,&#xD;
      fatigue, health-related fitness assessment and physical activity levels will be examined,&#xD;
      providing the most comprehensive assessment to date.&#xD;
&#xD;
      Discussion We expect to find an improvement in the immunological recovery, quality of life,&#xD;
      decreased acquisition of sedentary behavior and less fitness deconditioning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to inability to recruit participants.&#xD;
  </why_stopped>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hematological and Immunological Recovery</measure>
    <time_frame>This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT)</time_frame>
    <description>Assessment of the impact of the Exercise (EX) intervention on the immune recovery of pediatric autologous SCT patients will be based on four parameters (a) Recovery of different leukocyte cell subset (e.g., T cells, Natural killer cells, B cells, monocytes, neutrophils etc) in peripheral blood by flow cytometry, (b) Expression of activating and inhibitory Killer IRs by Gene expression analysis of 14 KIR genes will be done by RNA based real-time PCR analysis(c) Function of NK cells and their subsets by measuring in-vitro cytokine secretion and degranulation by different NK cell subsets (cytolytic and regulatory NK cells) on incubation with K-562 cell lines and (d) Levels of different pro-inflammatory and regulatory cytokines in serum using a bead-based array on Luminex.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>Assessment will be completed at baseline, 30, 90 and 180 days after SCT</time_frame>
    <description>Will be assessed using the Pediatric quality of life inventory (PedsQL) general and cancer module as a self-report, and PedsQL and Behavior Assessment System for Children (BASC-2) as parent proxy report. Fatigue will be assessed using the multidimensional PedsQL fatigue scale.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health-related fitness assessment</measure>
    <time_frame>Assessment will be completed at baseline, 30 and 90 days after SCT</time_frame>
    <description>Body composition; musculoskeletal fitness (flexibility, muscular strength and endurance); functional mobility and cardiorespiratory fitness will be performed.&#xD;
Body composition: weight, height, skinfold measure (biceps, triceps, subscapular and suprailiac).&#xD;
Flexibility: sit and reach Muscular strength: A hand- held dynamometer will be used to assess grip strength and knee extension.&#xD;
Muscular endurance: modified push up, partial curl-up and 30 seconds squat test.&#xD;
Functional mobility: Time up and go test (3 meters) Cardiorespiratory fitness: Treadmill submaximal test. Height and tanner stage will be used to determine duration of each stage (2-3 minutes) and initial velocity of the protocol.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>Assessment will be completed at baseline, 30, 90 and 180 days after SCT</time_frame>
    <description>A triaxial accelerometer (Actical - Phillips respironic) will be put on when the participant gets up from bed each day and worn until the participant is ready to fall asleep. Subjects can go about their normal, daily activities, including rigorous exercise, swimming or bathing. During each assessment subjects will be instructed to wear the activity monitor over their right hip on an elasticized belt for seven consecutive days. Additionally, participants will be asked to record, in a daily log, the time they put on and took off the monitor each day.</description>
  </other_outcome>
  <other_outcome>
    <measure>Demographic and health assessment</measure>
    <time_frame>This assessment will be perfomed at baseline, 15, 30, 60, 90 days after SCT</time_frame>
    <description>Demographic characteristics, health record information (type of cancer, disease status, co-morbid conditions, cancer treatment received, side-effects of treatment) and information related to SCT (platelet and neutrophil engraftment, conditioning regimen received, toxicities due to conditioning regimen, documented infection, incidence of fever) will be collected. A questionnaires will be filled out by the physician.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dietary intake</measure>
    <time_frame>Assessment will be completed at baseline, 30, 90 and 180 days after SCT</time_frame>
    <description>Usual dietary intake will be assessed using a 3-day dietary record. Dietary records will be analyzed by a Registered Dietitian using Diet Analysis Plus 10.0 software (Thomson Wadsworth, Toronto, Canada.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Cancer</condition>
  <condition>Autologous Hematopoietic Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>Exercise (EX)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will perform two phases of an EX program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will follow the standard care without any EX prescription.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EXERCISE (EX)</intervention_name>
    <description>This study will examine the effect of two phases of an EX program on several health related outcomes in pediatric patient undergoing autologous SCT. The first phase of the EX program will be an inpatient intervention and will begin when the child is hospitalized undergoing conditioning therapy and will continue until discharge.&#xD;
The second phase will be a 10-week outpatient intervention, beginning once the child is discharged. We will utilize a mixed EX program, including supervised (at the University of Calgary) and home-based training incorporating the use of the Nintendo ® Wii device™ (Wii Fit, Wii Dance and Sports™ games).</description>
    <arm_group_label>Exercise (EX)</arm_group_label>
    <other_name>PHYSICAL ACTIVITY</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>This group will be under standard care without any EX intervention.</description>
    <arm_group_label>Standard Care</arm_group_label>
    <other_name>Active comparator/ control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  autologous SCT at Alberta Children's Hospital (ACH) for malignancy&#xD;
&#xD;
          -  age 5 to 18 years of age&#xD;
&#xD;
          -  will be receiving myeloablative conditioning regimen&#xD;
&#xD;
          -  no evidence of cardiac or pulmonary failure associated with treatment (SF≥28%, EF ≥&#xD;
             50%)&#xD;
&#xD;
          -  no functional nor cognitive limitation that would prohibit performance of the&#xD;
             home-based training&#xD;
&#xD;
          -  approval by treating oncologist for participants&#xD;
&#xD;
          -  a parent or legal guardian must sign the consent form and&#xD;
&#xD;
          -  children should express verbal assent to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole S Culos-Reed, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary Faculty of Kinesiology, Faculty of Medicine and Department of Psychosocial Resources, Tom Baker Cancer Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carolina Chamorro-Viña, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Kinesiology, University of Calgary.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>October 24, 2016</last_update_submitted>
  <last_update_submitted_qc>October 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Dr. Nicole Culos-Reed</investigator_full_name>
    <investigator_title>Ph.D, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>exercise</keyword>
  <keyword>hematopoietic stem cell transplantation</keyword>
  <keyword>cancer</keyword>
  <keyword>quality of life</keyword>
  <keyword>immune system</keyword>
  <keyword>physical activity levels</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01666015
org study id: RF-CACICPES01
secondary id: University of Calgary
nct id: NCT01666015
lead sponsor: 
collaborator: 
has dmc: Yes
Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship
      and cure various oncologic diseases. However, this therapy is associated with high mortality
      rates and numerous negative side-effects. The recovery of the immune system is a special
      concern and plays a key role in the success of this treatment. In healthy populations it is
      known that exercise plays an important role in immune system regulation, but little is known
      about the role of exercise in the hematological and immunological recovery of children
      undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized
      Controlled Trial is: study the effect of an exercise program on immune cell recovery in
      patients undergoing autologous stem cell transplantation. The Secondary objective is to
      determine if an exercise intervention might diminish the deterioration of quality of life,
      physical fitness, and the acquisition of a sedentary lifestyle.

      Methods

      Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to
      18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or
      control group. The exercise group will participate in a two-phase exercise intervention (in
      and outpatient) from hospitalization until 10 weeks after discharge. The exercise program
      includes strength, flexibility and aerobic exercise. During the inpatient phase this program
      will be performed 5 times/week and will be supervised. The outpatient phase will combine a
      supervised session with two home-based exercise sessions with the use of the Wii device. The
      control group will follow the standard protocol without any specific exercise program. A
      range of outcomes, including quantitative and functional recovery of immune system, cytokine
      levels in serum, NK cells and their subset recovery and function, and gene expression of
      activating and inhibitory NK cell receptors, body composition, nutrition, quality of life,
      fatigue, health-related fitness assessment and physical activity levels will be examined,
      providing the most comprehensive assessment to date.

      Discussion We expect to find an improvement in the immunological recovery, quality of life,
      decreased acquisition of sedentary behavior and less fitness deconditioning.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Hematological and Immunological Recovery
time frame: This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT)
description: Assessment of the impact of the Exercise (EX) intervention on the immune recovery of pediatric autologous SCT patients will be based on four parameters (a) Recovery of different leukocyte cell subset (e.g., T cells, Natural killer cells, B cells, monocytes, neutrophils etc) in peripheral blood by flow cytometry, (b) Expression of activating and inhibitory Killer IRs by Gene expression analysis of 14 KIR genes will be done by RNA based real-time PCR analysis(c) Function of NK cells and their subsets by measuring in-vitro cytokine secretion and degranulation by different NK cell subsets (cytolytic and regulatory NK cells) on incubation with K-562 cell lines and (d) Levels of different pro-inflammatory and regulatory cytokines in serum using a bead-based array on Luminex.
measure: Quality of life (QOL)
time frame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT
description: Will be assessed using the Pediatric quality of life inventory (PedsQL) general and cancer module as a self-report, and PedsQL and Behavior Assessment System for Children (BASC-2) as parent proxy report. Fatigue will be assessed using the multidimensional PedsQL fatigue scale.
measure: Health-related fitness assessment
time frame: Assessment will be completed at baseline, 30 and 90 days after SCT
description: Body composition; musculoskeletal fitness (flexibility, muscular strength and endurance); functional mobility and cardiorespiratory fitness will be performed.
Body composition: weight, height, skinfold measure (biceps, triceps, subscapular and suprailiac).
Flexibility: sit and reach Muscular strength: A hand- held dynamometer will be used to assess grip strength and knee extension.
Muscular endurance: modified push up, partial curl-up and 30 seconds squat test.
Functional mobility: Time up and go test (3 meters) Cardiorespiratory fitness: Treadmill submaximal test. Height and tanner stage will be used to determine duration of each stage (2-3 minutes) and initial velocity of the protocol.
measure: Physical activity levels
time frame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT
description: A triaxial accelerometer (Actical - Phillips respironic) will be put on when the participant gets up from bed each day and worn until the participant is ready to fall asleep. Subjects can go about their normal, daily activities, including rigorous exercise, swimming or bathing. During each assessment subjects will be instructed to wear the activity monitor over their right hip on an elasticized belt for seven consecutive days. Additionally, participants will be asked to record, in a daily log, the time they put on and took off the monitor each day.
measure: Demographic and health assessment
time frame: This assessment will be perfomed at baseline, 15, 30, 60, 90 days after SCT
description: Demographic characteristics, health record information (type of cancer, disease status, co-morbid conditions, cancer treatment received, side-effects of treatment) and information related to SCT (platelet and neutrophil engraftment, conditioning regimen received, toxicities due to conditioning regimen, documented infection, incidence of fever) will be collected. A questionnaires will be filled out by the physician.
measure: Dietary intake
time frame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT
description: Usual dietary intake will be assessed using a 3-day dietary record. Dietary records will be analyzed by a Registered Dietitian using Diet Analysis Plus 10.0 software (Thomson Wadsworth, Toronto, Canada.
arm group label: Exercise (EX)
arm group type: Experimental
description: This group will perform two phases of an EX program.
arm group label: Standard Care
arm group type: Active Comparator
description: This group will follow the standard care without any EX prescription.
intervention type: Other
intervention name: EXERCISE (EX)
description: This study will examine the effect of two phases of an EX program on several health related outcomes in pediatric patient undergoing autologous SCT. The first phase of the EX program will be an inpatient intervention and will begin when the child is hospitalized undergoing conditioning therapy and will continue until discharge.
The second phase will be a 10-week outpatient intervention, beginning once the child is discharged. We will utilize a mixed EX program, including supervised (at the University of Calgary) and home-based training incorporating the use of the Nintendo ® Wii device™ (Wii Fit, Wii Dance and Sports™ games).
arm group label: Exercise (EX)
other name: PHYSICAL ACTIVITY
intervention type: Other
intervention name: Standard Care
description: This group will be under standard care without any EX intervention.
arm group label: Standard Care
other name: Active comparator/ control
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Nicole S Culos-Reed, Ph.D
role: Principal Investigator
affiliation: University of Calgary Faculty of Kinesiology, Faculty of Medicine and Department of Psychosocial Resources, Tom Baker Cancer Centre
last name: Carolina Chamorro-Viña, Ph.D
role: Principal Investigator
affiliation: Faculty of Kinesiology, University of Calgary.
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Dr. Nicole Culos-Reed
investigator title: Ph.D, Associate Professor