<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/NCT03005392</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-EJE-2013-150</org_study_id>
    <nct_id>NCT03005392</nct_id>
  </id_info>
  <brief_title>Home-exercise Program for Children and Adolescent Survivors of Acute Lymphoblastic Leukemia</brief_title>
  <official_title>Effects of a Physical Exercise Program in Patients With Diagnosis of Acute Lymphoblastic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Exercise programs in children and teenagers with Acute Lymphoblastic Leukemia (ALL)&#xD;
           strengthens their physical fitness.&#xD;
&#xD;
        -  Exercising improves muscular and functional mobility fitness after finalizing&#xD;
           chemotherapy in children and teenagers diagnosed with ALL.&#xD;
&#xD;
        -  Assess cardiological changes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children and adolescents survivors of ALL will be randomly assigned to the intervention group&#xD;
      and to the control group. A home-exercise program will be designed for 16 weeks with 55&#xD;
      sessions, combining aerobic, strength and flexibility exercises of light and moderate&#xD;
      intensity. The following tests will be performed to evaluate the effects of the intervention&#xD;
      program: Echocardiography, Tape treadmill test using a ramp protocol to assess&#xD;
      cardiorespiratory fitness, hand grip test to assess muscular grip strength, Timed Up test And&#xD;
      Go Test (TUG) and Timed Up and Down Stairs Test (TUDS) to assess functional mobility, the sit&#xD;
      and reach test to assess flexibility and a questionnaire to assess levels of physical&#xD;
      activity. The control group will perform their usual physical activity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiorespiratory exercise test</measure>
    <time_frame>1 year</time_frame>
    <description>For this test a treadmill was used utilizing a sloped ramp protocol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Echocardiography</measure>
    <time_frame>1 year</time_frame>
    <description>Index of the lateral mitral annulus level (isovolumetric contraction time&#xD;
+ Isovolumetric relaxation time / ejection time), measured by Echocardiography. Index of TEI at the level of the septal mitral ring (isovolumetric contraction time + Isovolumetric relaxation time / ejection time), measured by means of Echocardiography. TEI index at the level of the tricuspid ring (isovolumetric contraction time + Isovolumetric relaxation time / ejection time), measured by means of Echocardiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional mobility</measure>
    <time_frame>1 year</time_frame>
    <description>For this variable the Time Up and Go Test (TUG) was used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional mobility</measure>
    <time_frame>1 year</time_frame>
    <description>For this variable the Time Up and Down Stairs Test (TUDS) was used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength</measure>
    <time_frame>1 year</time_frame>
    <description>To measure this variable, the hand grip test was utilized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexibility</measure>
    <time_frame>1 year</time_frame>
    <description>For this variable the sit-and-reach (SR) test was used, that of which allowed evaluation of the hamstring muscle extensibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of physical activity</measure>
    <time_frame>1 year</time_frame>
    <description>This variable was measured utilizing the family of the international questionnaire of physical activity (IPAQ). For children between the ages of 8-12 the Physical Activity Questionnaire for Children (PAQ-C) version was used, and for adolescents between the ages of 13-18 the PAQ-A form was used.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>Evaluate physical fitness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evaluate Cardiological changes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evaluate activity physical</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control grup</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will be recommended to maintain a level of physical activity they would routinely and habitually have during the 4 months that the study will last.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise</intervention_name>
    <description>An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform.&#xD;
The physiotherapist will contact the patient and/or tutor weekly so as to answer and doubts they may have with respect to the exercise program and to further supervise their compliance (group with intervention).</description>
    <arm_group_label>Evaluate Cardiological changes</arm_group_label>
    <arm_group_label>Evaluate activity physical</arm_group_label>
    <arm_group_label>Evaluate physical fitness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study included of children and adolescents between 7 and 18 years old that were at&#xD;
             time in complete remission for a minimum of one year of their neoplastic disease and&#xD;
             had finalized their chemotherapy treatments by the time they began the physical&#xD;
             exercise program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with structural cardiac anomalies, congenital cardiopathies, those in&#xD;
             recurrence of their neoplastic diseases, signs of clinical or subclinical cardiac&#xD;
             insufficiency and an echocardiography with alterations in systolic and/or diastolic&#xD;
             function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Claudia Delgado</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>R. Peris-Bonet, D. Salmerón, M. A. Martínez-Beneito, J. Galceran, R. Marcos Gragera, S. Felipe, V. González &amp; J. Sanchez de Toledo Codina. Childhood cancer incidence and survival in Spain. Annals of Oncology 2010: 21 arner JT.; Bell W.; Webb DK.; Gregory JW. Daily energy expenditure and physical activity in survivors of childhood malignancy. Pediatr Res 43. 1998, 607-613 Lucia A.; Earnest C.; Perez M. Cancer-related fatigue: can exercise physiology assist oncologists?. Lancet Oncol 4. 2003, 616-625 San Juan AF.; Fleck SJ.; Chamorro C.; Maté-Muñoz JL.; Garcia-Castro J.; Ramirez M.; Madero L.; Lucia A. Early-phase adaptations to intra-hospital training in strength and functional mobility of children with Leucemia.J Strength Cond Res. 2006</citation>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Physical therapy</keyword>
  <keyword>Cardiorespiratory fitness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03005392
org study id: IIBSP-EJE-2013-150
nct id: NCT03005392
lead sponsor: 
has dmc: Yes
-  Exercise programs in children and teenagers with Acute Lymphoblastic Leukemia (ALL)
           strengthens their physical fitness.

        -  Exercising improves muscular and functional mobility fitness after finalizing
           chemotherapy in children and teenagers diagnosed with ALL.

        -  Assess cardiological changes
Children and adolescents survivors of ALL will be randomly assigned to the intervention group
      and to the control group. A home-exercise program will be designed for 16 weeks with 55
      sessions, combining aerobic, strength and flexibility exercises of light and moderate
      intensity. The following tests will be performed to evaluate the effects of the intervention
      program: Echocardiography, Tape treadmill test using a ramp protocol to assess
      cardiorespiratory fitness, hand grip test to assess muscular grip strength, Timed Up test And
      Go Test (TUG) and Timed Up and Down Stairs Test (TUDS) to assess functional mobility, the sit
      and reach test to assess flexibility and a questionnaire to assess levels of physical
      activity. The control group will perform their usual physical activity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cardiorespiratory exercise test
time frame: 1 year
description: For this test a treadmill was used utilizing a sloped ramp protocol
measure: Echocardiography
time frame: 1 year
description: Index of the lateral mitral annulus level (isovolumetric contraction time
+ Isovolumetric relaxation time / ejection time), measured by Echocardiography. Index of TEI at the level of the septal mitral ring (isovolumetric contraction time + Isovolumetric relaxation time / ejection time), measured by means of Echocardiography. TEI index at the level of the tricuspid ring (isovolumetric contraction time + Isovolumetric relaxation time / ejection time), measured by means of Echocardiography.
measure: Functional mobility
time frame: 1 year
description: For this variable the Time Up and Go Test (TUG) was used
measure: Functional mobility
time frame: 1 year
description: For this variable the Time Up and Down Stairs Test (TUDS) was used
measure: Strength
time frame: 1 year
description: To measure this variable, the hand grip test was utilized
measure: Flexibility
time frame: 1 year
description: For this variable the sit-and-reach (SR) test was used, that of which allowed evaluation of the hamstring muscle extensibility
measure: Level of physical activity
time frame: 1 year
description: This variable was measured utilizing the family of the international questionnaire of physical activity (IPAQ). For children between the ages of 8-12 the Physical Activity Questionnaire for Children (PAQ-C) version was used, and for adolescents between the ages of 13-18 the PAQ-A form was used.
arm group label: Evaluate physical fitness
arm group type: Experimental
description: An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform
arm group label: Evaluate Cardiological changes
arm group type: Experimental
description: An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform
arm group label: Evaluate activity physical
arm group type: Experimental
description: An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform
arm group label: control grup
arm group type: No Intervention
description: The control group will be recommended to maintain a level of physical activity they would routinely and habitually have during the 4 months that the study will last.
intervention type: Other
intervention name: exercise
description: An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform.
The physiotherapist will contact the patient and/or tutor weekly so as to answer and doubts they may have with respect to the exercise program and to further supervise their compliance (group with intervention).
arm group label: Evaluate Cardiological changes
arm group label: Evaluate activity physical
arm group label: Evaluate physical fitness
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Spain
citation: R. Peris-Bonet, D. Salmerón, M. A. Martínez-Beneito, J. Galceran, R. Marcos Gragera, S. Felipe, V. González & J. Sanchez de Toledo Codina. Childhood cancer incidence and survival in Spain. Annals of Oncology 2010: 21 arner JT.; Bell W.; Webb DK.; Gregory JW. Daily energy expenditure and physical activity in survivors of childhood malignancy. Pediatr Res 43. 1998, 607-613 Lucia A.; Earnest C.; Perez M. Cancer-related fatigue: can exercise physiology assist oncologists?. Lancet Oncol 4. 2003, 616-625 San Juan AF.; Fleck SJ.; Chamorro C.; Maté-Muñoz JL.; Garcia-Castro J.; Ramirez M.; Madero L.; Lucia A. Early-phase adaptations to intra-hospital training in strength and functional mobility of children with Leucemia.J Strength Cond Res. 2006
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
sharing ipd: Undecided