<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/NCT03007602</url>
  </required_header>
  <id_info>
    <org_study_id>Gazi-231</org_study_id>
    <nct_id>NCT03007602</nct_id>
  </id_info>
  <brief_title>Effects of Upper Extremity Aerobic Exercise Training in Hematopoietic Stem Cell Transplantation Recipients</brief_title>
  <official_title>Effects of Upper Extremity Aerobic Exercise Training in Hematopoietic Stem Cell Transplantation Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hematologic malignancy is a tumor of myeloid or lymphatic cells that affects lymph nodes with&#xD;
      the involvement of blood, bone marrow or other organs.There are various treatment options for&#xD;
      hematological malignancies ranging from follow-up to single or multiple agent chemotherapy,&#xD;
      radiotherapy, immunotherapy and autologous or allogeneic hematopoietic stem cell&#xD;
      transplantations (HSCT). The general recommendation for patients is to relax and avoid&#xD;
      intense exercise, regardless of the devastating consequences of neglecting physical exercise.&#xD;
      Patients also go to relaxation by reducing their activity to avoid fatigue, which leads to&#xD;
      loss of muscle strength and endurance. As a consequence of all, fatigue, vomiting, weight&#xD;
      loss, anemia, depression, decreased aerobic capacity, muscle weakness, decreased physical&#xD;
      function and poor quality of life are observed in HSCT recipients. It has been shown that&#xD;
      physical exercises improve oxygen consumption, depression and fatigue, cardiorespiratory&#xD;
      fitness, muscle strength and physical well-being in patients with hematologic malignancies&#xD;
      who are at stages of various treatments. In literature, effects of upper extremity aerobic&#xD;
      exercise training have been investigated in patients with spinal cord injury, neuromuscular&#xD;
      diseases, claudication, hypertension, multiple sclerosis, heart failure, paraplegic patients&#xD;
      and healthy individuals. Results of these studies has shown that upper extremity aerobic&#xD;
      exercise training improves walking distance, increases oxygen pulse, muscle strength and&#xD;
      endurance of upper extremity. No study was observed to investigate the effects of upper&#xD;
      extremity aerobic exercise training on exercise capacity and quality of life in HSCT&#xD;
      recipients, as we know. For this reason, our aim is to investigate the effects of upper&#xD;
      extremity aerobic exercise training on exercise capacity and quality of life in HSCT&#xD;
      recipients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Minimum 30 allogeneic and autologous HSCT recipients (˃100 days past post-transplant status)&#xD;
      will be included. Before and after 6-week upper extremity aerobic exercise training, maximal&#xD;
      and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary&#xD;
      functions, physical activity, dyspnea and fatigue perception, anxiety, depression and quality&#xD;
      of life were evaluated. Primary outcome measurements were exercise capacity and quality of&#xD;
      life , secondary outcomes were respiratory and peripheral muscle strength, pulmonary&#xD;
      functions, physical activity, dyspnea and fatigue perception, anxiety and depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>functional exercise capacity evaluation</measure>
    <time_frame>6-week</time_frame>
    <description>Evaluated with 6-minute walking test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pulmonary functions test</measure>
    <time_frame>6-week</time_frame>
    <description>Evaluated with spirometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle strength</measure>
    <time_frame>6-week</time_frame>
    <description>Evaluated with a hand-held dynamometer for peripheral muscles, mouth pressure device for respiratory muscle strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cough strength</measure>
    <time_frame>6-week</time_frame>
    <description>Evaluated with peak flow meter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity level</measure>
    <time_frame>6-week</time_frame>
    <description>Evaluated with a metabolic holter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fatigue severity</measure>
    <time_frame>6-week</time_frame>
    <description>Evaluated using Fatigue Severity Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety and depression perception</measure>
    <time_frame>6-week</time_frame>
    <description>Evaluated using Hospital Anxiety and Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dyspnea perception</measure>
    <time_frame>6-week</time_frame>
    <description>Evaluated using Modified Medical Research Council Dyspnea scale (MMRC) and Modified Borg Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life level</measure>
    <time_frame>6-week</time_frame>
    <description>evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal exercise capacity evaluation</measure>
    <time_frame>6-week</time_frame>
    <description>evaluated using Modified Incremental Shuttle Walk Test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <condition>Aerobic Exercise</condition>
  <arm_group>
    <arm_group_label>Treatment group: aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The upper extremity aerobic exercise training with an arm ergometer will be performed in the treatment group so that training intensity will be between 60% and 80% of the maximum heart rate, dyspnea perception will be 3-4 according to Modified Borg Scale and fatigue perception will be 5-6 according to Modified Borg Scale, training duration will be a 6-week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: deep breathing exercise</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Deep breathing exercises combinated with arm movements will be given as a home schedule in the control group. Training duration will be a 6-week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Upper Extremity Aerobic Exercise</intervention_name>
    <description>Range of maximal heart rate is being followed by a polar band during supervised session each week.&#xD;
Aerobic exercise is being trained for 30 min-per/day, 3 days/week, 6 weeks. All sessions are being performed by a physiotherapist at cardiopulmonary rehabilitation department.</description>
    <arm_group_label>Treatment group: aerobic exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being an hematopoietic stem cell transplantation recipient during the&#xD;
             intermediate/late post-transplant phase (&gt;100 days),&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  under standard medications.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having a cognitive disorder,&#xD;
&#xD;
          -  orthopedic or neurological disease with a potential to affect functional capacity,&#xD;
&#xD;
          -  comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute&#xD;
             infections or pneumonia,&#xD;
&#xD;
          -  problems which may prevent training such as visual problems and mucositis&#xD;
&#xD;
          -  having metastasis to any region (bone etc.)&#xD;
&#xD;
          -  having acute hemorrhage in the intracranial and / or lung and other areas&#xD;
&#xD;
          -  having any contraindication to exercise training&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gülşah Barğı, MSc.</last_name>
    <role>Study Chair</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Meral Boşnak Güçlü, PhD.</last_name>
    <role>Study Director</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zübeyde Nur Özkurt, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Münci Yağcı, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/?term=2)%09Cullen+M.+%E2%80%99Best+supportive+care%E2%80%99+has+had+its+day.+The+Lancet+Oncology+2001%3B2(3)%3A173%E2%80%935.+%5BPUBMED%3A+11902569%5D</url>
    <description>'Best supportive care' has had its day.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/?term=3)%09Tosetto+A%2C+Balduini+CL%2C+Cattaneo+M%2C+De+Candia+E%2C+Mariani+G%2C+Molinari+AC%2C+et+al.Management+of+bleeding+and+of+invasive+procedures+in+patients+with+platelet+disorders+and%2For+thrombocytopenia%3A+Guidelines+of+the+Italian+Society+for+Haemostasis+and+Thrombosis+(SISET).+Thrombosis+Research+2009%3B124(5)%3Ae13%E2%80%938.+%5BPUBMED%3A+19631969%5D</url>
    <description>Management of bleeding and of invasive procedures in patients with platelet disorders and/or thrombocytopenia: Guidelines of the Italian Society for Haemostasis and Thrombosis (SISET).</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Bergenthal+N%2C+Will+A%2C+Streckmann+F%2C+Wolkewitz+KD%2C+Monsef+I%2C+Engert+A%2C+Elter+T%2C+Skoetz+N.+Aerobic+physical+exercise+for+adult+patients+with+haematological+malignancies.+Cochrane+Database+Syst+Rev.</url>
    <description>Aerobic physical exercise for adult patients with haematological malignancies.</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Meral Boşnak Güçlü</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Hematopoietic stem cell transplantation</keyword>
  <keyword>Aerobic exercise</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Muscle Strength</keyword>
  <keyword>Depression</keyword>
  <keyword>exercise capacity</keyword>
  <keyword>dyspnea</keyword>
  <keyword>anxiety</keyword>
  <keyword>fatigue</keyword>
  <keyword>pulmonary functions</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.</ipd_description>
  </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/NCT03007602
org study id: Gazi-231
nct id: NCT03007602
lead sponsor: 
has dmc: No
Hematologic malignancy is a tumor of myeloid or lymphatic cells that affects lymph nodes with
      the involvement of blood, bone marrow or other organs.There are various treatment options for
      hematological malignancies ranging from follow-up to single or multiple agent chemotherapy,
      radiotherapy, immunotherapy and autologous or allogeneic hematopoietic stem cell
      transplantations (HSCT). The general recommendation for patients is to relax and avoid
      intense exercise, regardless of the devastating consequences of neglecting physical exercise.
      Patients also go to relaxation by reducing their activity to avoid fatigue, which leads to
      loss of muscle strength and endurance. As a consequence of all, fatigue, vomiting, weight
      loss, anemia, depression, decreased aerobic capacity, muscle weakness, decreased physical
      function and poor quality of life are observed in HSCT recipients. It has been shown that
      physical exercises improve oxygen consumption, depression and fatigue, cardiorespiratory
      fitness, muscle strength and physical well-being in patients with hematologic malignancies
      who are at stages of various treatments. In literature, effects of upper extremity aerobic
      exercise training have been investigated in patients with spinal cord injury, neuromuscular
      diseases, claudication, hypertension, multiple sclerosis, heart failure, paraplegic patients
      and healthy individuals. Results of these studies has shown that upper extremity aerobic
      exercise training improves walking distance, increases oxygen pulse, muscle strength and
      endurance of upper extremity. No study was observed to investigate the effects of upper
      extremity aerobic exercise training on exercise capacity and quality of life in HSCT
      recipients, as we know. For this reason, our aim is to investigate the effects of upper
      extremity aerobic exercise training on exercise capacity and quality of life in HSCT
      recipients.
Minimum 30 allogeneic and autologous HSCT recipients (˃100 days past post-transplant status)
      will be included. Before and after 6-week upper extremity aerobic exercise training, maximal
      and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary
      functions, physical activity, dyspnea and fatigue perception, anxiety, depression and quality
      of life were evaluated. Primary outcome measurements were exercise capacity and quality of
      life , secondary outcomes were respiratory and peripheral muscle strength, pulmonary
      functions, physical activity, dyspnea and fatigue perception, anxiety and depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: functional exercise capacity evaluation
time frame: 6-week
description: Evaluated with 6-minute walking test
measure: pulmonary functions test
time frame: 6-week
description: Evaluated with spirometer
measure: muscle strength
time frame: 6-week
description: Evaluated with a hand-held dynamometer for peripheral muscles, mouth pressure device for respiratory muscle strength
measure: cough strength
time frame: 6-week
description: Evaluated with peak flow meter
measure: physical activity level
time frame: 6-week
description: Evaluated with a metabolic holter
measure: fatigue severity
time frame: 6-week
description: Evaluated using Fatigue Severity Scale
measure: anxiety and depression perception
time frame: 6-week
description: Evaluated using Hospital Anxiety and Depression Scale
measure: dyspnea perception
time frame: 6-week
description: Evaluated using Modified Medical Research Council Dyspnea scale (MMRC) and Modified Borg Scale
measure: quality of life level
time frame: 6-week
description: evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
measure: maximal exercise capacity evaluation
time frame: 6-week
description: evaluated using Modified Incremental Shuttle Walk Test
arm group label: Treatment group: aerobic exercise
arm group type: Experimental
description: The upper extremity aerobic exercise training with an arm ergometer will be performed in the treatment group so that training intensity will be between 60% and 80% of the maximum heart rate, dyspnea perception will be 3-4 according to Modified Borg Scale and fatigue perception will be 5-6 according to Modified Borg Scale, training duration will be a 6-week.
arm group label: Control group: deep breathing exercise
arm group type: No Intervention
description: Deep breathing exercises combinated with arm movements will be given as a home schedule in the control group. Training duration will be a 6-week.
intervention type: Other
intervention name: Upper Extremity Aerobic Exercise
description: Range of maximal heart rate is being followed by a polar band during supervised session each week.
Aerobic exercise is being trained for 30 min-per/day, 3 days/week, 6 weeks. All sessions are being performed by a physiotherapist at cardiopulmonary rehabilitation department.
arm group label: Treatment group: aerobic exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gülşah Barğı, MSc.
role: Study Chair
affiliation: Gazi University
last name: Meral Boşnak Güçlü, PhD.
role: Study Director
affiliation: Gazi University
last name: Zübeyde Nur Özkurt, PhD.
role: Principal Investigator
affiliation: Gazi University
last name: Münci Yağcı, PhD.
role: Principal Investigator
affiliation: Gazi University
facility: 
country: Turkey
url: http://www.ncbi.nlm.nih.gov/pubmed/?term=2)%09Cullen+M.+%E2%80%99Best+supportive+care%E2%80%99+has+had+its+day.+The+Lancet+Oncology+2001%3B2(3)%3A173%E2%80%935.+%5BPUBMED%3A+11902569%5D
description: 'Best supportive care' has had its day.
url: http://www.ncbi.nlm.nih.gov/pubmed/?term=3)%09Tosetto+A%2C+Balduini+CL%2C+Cattaneo+M%2C+De+Candia+E%2C+Mariani+G%2C+Molinari+AC%2C+et+al.Management+of+bleeding+and+of+invasive+procedures+in+patients+with+platelet+disorders+and%2For+thrombocytopenia%3A+Guidelines+of+the+Italian+Society+for+Haemostasis+and+Thrombosis+(SISET).+Thrombosis+Research+2009%3B124(5)%3Ae13%E2%80%938.+%5BPUBMED%3A+19631969%5D
description: Management of bleeding and of invasive procedures in patients with platelet disorders and/or thrombocytopenia: Guidelines of the Italian Society for Haemostasis and Thrombosis (SISET).
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Bergenthal+N%2C+Will+A%2C+Streckmann+F%2C+Wolkewitz+KD%2C+Monsef+I%2C+Engert+A%2C+Elter+T%2C+Skoetz+N.+Aerobic+physical+exercise+for+adult+patients+with+haematological+malignancies.+Cochrane+Database+Syst+Rev.
description: Aerobic physical exercise for adult patients with haematological malignancies.
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Meral Boşnak Güçlü
investigator title: Associate professor
sharing ipd: No
ipd description: There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.