<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/NCT02193399</url>
  </required_header>
  <id_info>
    <org_study_id>TRASFIS</org_study_id>
    <secondary_id>TRAS</secondary_id>
    <nct_id>NCT02193399</nct_id>
  </id_info>
  <brief_title>Physiotherapy in Hematopoietic Stem Cell Transplantation</brief_title>
  <acronym>TRAS</acronym>
  <official_title>Effectiveness of Physiotherapy in the Prevention of Physical Sequelae in Patients Treated With Hematopoietic Stem Cell Transplantation. A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research project with patients undergoing allogeneic hematopoietic transplantation in the&#xD;
      hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca. The main&#xD;
      objective is to assess the differences in skeletal muscle and functional variables in the&#xD;
      experimental group underwent a physiotherapy treatment that takes place during the pre-and&#xD;
      post-transplant period, compared to a control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main characteristics of the study are:&#xD;
&#xD;
        -  Randomized, prospective and longitudinal in patients receiving allogeneic hematopoietic&#xD;
           stem cell transplantation clinical trial.&#xD;
&#xD;
        -  A descriptive study of skeletal muscle characteristics of patients undergoing allogeneic&#xD;
           hematopoietic transplantation for hematologic malignancies before and after carrying out&#xD;
           a treatment with stem cells.&#xD;
&#xD;
        -  Clinical study of the variables of strength, mobility, proprioception and upper and&#xD;
           lower pain in patients with hematologic malignancy member before and after cancer&#xD;
           treatment.&#xD;
&#xD;
        -  Clinical study of the effectiveness of physiotherapy treatment in clinical&#xD;
           characteristics (strength, mobility, proprioception and pain) in patients undergoing&#xD;
           allogeneic stem cell transplantation.&#xD;
&#xD;
        -  Clinical study of psychosocial variables that are affected by hematological treatment,&#xD;
           and the influence on them of a physiotherapy treatment.&#xD;
&#xD;
      The data obtained in this project to identify and treat those functional deficits that appear&#xD;
      as a result of cancer treatment and influencing patients, regarding the evolution of the&#xD;
      disease and its treatment. They will use different psychosocial questionnaires and functional&#xD;
      tests based on scientific evidence and the reliability of these, as well as its specific&#xD;
      design for patients with hematologic cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">May 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in joint range of motion</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days)</time_frame>
    <description>Will be evaluated with a universal goniometer following validated protocols of measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in muscle strength of quadriceps, the gastrocnemius and biceps</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>It is measured with the scale of Daniels and a dynamometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in proprioception</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>It is measured with a balance platform and supports uni and bipodal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in pain perception</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>It will be evaluated with the visual analogue scale and algometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the perception of fatigue</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>Using the Spanish version of the Brief Fatigue Inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in body mass</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>By using the measurement tool TANITA calculate bone, muscle and fat mass, as well as the amount of fluid of patients at each evaluation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the perception of quality of life</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>Using the self-questionnaire SF-36 health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the profile of disease consequences</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>Using the questionnaire Sickness Impact Profile (SIP)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in coping with the disease</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>Using the scale questionnaire Mental Adjustment to Cancer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in perception of anxiety</measure>
    <time_frame>Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>Using the STAI questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hematopoietic recovery</measure>
    <time_frame>After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>Measuring the rate of graft failure and the transfusion dependence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response to the transplantation</measure>
    <time_frame>After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>By analyzing the rate and type of response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infectious complications</measure>
    <time_frame>After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>By measuring the rate, type and severity of infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Noninfectious complications</measure>
    <time_frame>After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>Measuring the rate of EVOH (number and percentage)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunological recovery</measure>
    <time_frame>after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>By measuring the number and percentage of B lymphocytes, T lymphocytes and NK lymphocytes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisations of the patient after transplantation</measure>
    <time_frame>after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).</time_frame>
    <description>Measuring the number of hospitalizations, the number of days in hospital and the cause of same</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Socio-demographic variables</measure>
    <time_frame>Screening visit (one month before hospital admission)</time_frame>
    <description>Gender (male, female), academic education (university education, basic education, vocational training), marital status (single, married, divorced, widowed), employment status (self-employed, employed as an employee, unemployed) and distance to hospital (km)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical variables</measure>
    <time_frame>Screening visit (one month before hospital admission)</time_frame>
    <description>Medical diagnosis, age (years), height (cm), weight (kg)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hematologic Malignancy</condition>
  <condition>Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>Physiotherapy exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients undergoing allogeneic transplantation without treatment of physiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy in patients with stem cell transplantation</intervention_name>
    <description>The exercises are repeated in both upper limbs and both lower limbs. All exercises are performed with specific respiratory exercises simultaneously the movement that takes place each year form.&#xD;
The exercises are carried out by the physiotherapist applying in a passive way (ascending or descending) progressive strength and degree of difficulty and variables depending on the clinical condition of the patient.</description>
    <arm_group_label>Physiotherapy exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged between 18 and 70 years.&#xD;
&#xD;
          -  Patients with a diagnosis of hematologic malignancy that will be subjected to&#xD;
             hematopoietic transplantation.&#xD;
&#xD;
          -  Patients offer sufficient guarantee adherence to protocol.&#xD;
&#xD;
          -  Patients who have previously signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with inability to walk, before treatment.&#xD;
&#xD;
          -  Patients whose medical judgment contraindicated inclusion in a physiotherapy&#xD;
             intervention.&#xD;
&#xD;
          -  Patients with psychotic traits, brain damage or senility prevention of the correct&#xD;
             understanding of physical therapy.&#xD;
&#xD;
          -  Patients with inability to sign informed consent or understanding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JORGE MONTSERRAT COLL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clínico Universitario Virgen de la Arrixaca</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>RUBÉN CUESTA-BARRIUSO, PhD</last_name>
    <phone>968278806</phone>
    <email>ruben.cuestab@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Virgen de la Arrixaca</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>RUBÉN CUESTA-BARRIUSO, PhD</last_name>
      <phone>968278806</phone>
      <email>ruben.cuestab@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>JORGE MONTSERRAT COLL, MD</last_name>
      <phone>968369532</phone>
      <email>jorge.monserrat@carm.es</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>RUBÉN CUESTA-BARRIUSO</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Stem cell transplantation</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Cancer</keyword>
  <keyword>Psychosocial aspects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02193399
org study id: TRASFIS
secondary id: TRAS
nct id: NCT02193399
lead sponsor: 
has dmc: No
Research project with patients undergoing allogeneic hematopoietic transplantation in the
      hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca. The main
      objective is to assess the differences in skeletal muscle and functional variables in the
      experimental group underwent a physiotherapy treatment that takes place during the pre-and
      post-transplant period, compared to a control group.
The main characteristics of the study are:

        -  Randomized, prospective and longitudinal in patients receiving allogeneic hematopoietic
           stem cell transplantation clinical trial.

        -  A descriptive study of skeletal muscle characteristics of patients undergoing allogeneic
           hematopoietic transplantation for hematologic malignancies before and after carrying out
           a treatment with stem cells.

        -  Clinical study of the variables of strength, mobility, proprioception and upper and
           lower pain in patients with hematologic malignancy member before and after cancer
           treatment.

        -  Clinical study of the effectiveness of physiotherapy treatment in clinical
           characteristics (strength, mobility, proprioception and pain) in patients undergoing
           allogeneic stem cell transplantation.

        -  Clinical study of psychosocial variables that are affected by hematological treatment,
           and the influence on them of a physiotherapy treatment.

      The data obtained in this project to identify and treat those functional deficits that appear
      as a result of cancer treatment and influencing patients, regarding the evolution of the
      disease and its treatment. They will use different psychosocial questionnaires and functional
      tests based on scientific evidence and the reliability of these, as well as its specific
      design for patients with hematologic cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in joint range of motion
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days)
description: Will be evaluated with a universal goniometer following validated protocols of measurement
measure: Changes in muscle strength of quadriceps, the gastrocnemius and biceps
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: It is measured with the scale of Daniels and a dynamometer.
measure: Changes in proprioception
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: It is measured with a balance platform and supports uni and bipodal
measure: Changes in pain perception
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: It will be evaluated with the visual analogue scale and algometer
measure: Changes in the perception of fatigue
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: Using the Spanish version of the Brief Fatigue Inventory
measure: Changes in body mass
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: By using the measurement tool TANITA calculate bone, muscle and fat mass, as well as the amount of fluid of patients at each evaluation.
measure: Changes in the perception of quality of life
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: Using the self-questionnaire SF-36 health
measure: Changes in the profile of disease consequences
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: Using the questionnaire Sickness Impact Profile (SIP)
measure: Changes in coping with the disease
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: Using the scale questionnaire Mental Adjustment to Cancer
measure: Change in perception of anxiety
time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: Using the STAI questionnaire
measure: Hematopoietic recovery
time frame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: Measuring the rate of graft failure and the transfusion dependence
measure: Response to the transplantation
time frame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: By analyzing the rate and type of response
measure: Infectious complications
time frame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: By measuring the rate, type and severity of infections
measure: Noninfectious complications
time frame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: Measuring the rate of EVOH (number and percentage)
measure: Immunological recovery
time frame: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: By measuring the number and percentage of B lymphocytes, T lymphocytes and NK lymphocytes.
measure: Hospitalisations of the patient after transplantation
time frame: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
description: Measuring the number of hospitalizations, the number of days in hospital and the cause of same
measure: Socio-demographic variables
time frame: Screening visit (one month before hospital admission)
description: Gender (male, female), academic education (university education, basic education, vocational training), marital status (single, married, divorced, widowed), employment status (self-employed, employed as an employee, unemployed) and distance to hospital (km)
measure: Clinical variables
time frame: Screening visit (one month before hospital admission)
description: Medical diagnosis, age (years), height (cm), weight (kg)
arm group label: Physiotherapy exercises
arm group type: Experimental
description: Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises
arm group label: Control group
arm group type: No Intervention
description: Patients undergoing allogeneic transplantation without treatment of physiotherapy
intervention type: Other
intervention name: Physiotherapy in patients with stem cell transplantation
description: The exercises are repeated in both upper limbs and both lower limbs. All exercises are performed with specific respiratory exercises simultaneously the movement that takes place each year form.
The exercises are carried out by the physiotherapist applying in a passive way (ascending or descending) progressive strength and degree of difficulty and variables depending on the clinical condition of the patient.
arm group label: Physiotherapy exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: JORGE MONTSERRAT COLL, MD
role: Principal Investigator
affiliation: Hospital Clínico Universitario Virgen de la Arrixaca
last name: RUBÉN CUESTA-BARRIUSO, PhD
phone: 968278806
email: ruben.cuestab@gmail.com
facility: 
contact: 
contact backup: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: RUBÉN CUESTA-BARRIUSO
investigator title: PhD
mesh term: Hematologic Neoplasms