<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/NCT04496011</url>
  </required_header>
  <id_info>
    <org_study_id>TMO 2020</org_study_id>
    <nct_id>NCT04496011</nct_id>
  </id_info>
  <brief_title>Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation</brief_title>
  <official_title>Effect of the Use of a Cycloergometer on the Physical Performance of Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized and Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Health Science of Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Health Science of Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physiological changes caused by hematological diseases associated with high dose chemotherapy&#xD;
      have a negative impact on patient's functionality, making them more fragile and vulnerable&#xD;
      after hematopoietic cell transplantation. Currently, randomized studies have shown that&#xD;
      physical exercise can contribute to improve Quality of Life of these patients. In this&#xD;
      randomized controlled trial, we will study the effect of using the bicycle ergometer on the&#xD;
      physical performance of patients undergoing transplantation of hematopoietic stem cells&#xD;
      (HSCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The sample consists of 30 patients diagnosed with leukemia, lymphoma and multiple myeloma,&#xD;
      undergoing high-dose chemotherapy and hematopoietic stem cells transplantation, who will be&#xD;
      randomized into two groups. The results of muscle strength in the lower limbs, general&#xD;
      mobility, fatigue and clinical symptoms will be compared between the control group and the&#xD;
      experimental group.&#xD;
&#xD;
      The control group will perform an exercise program based on the standard protocol of the&#xD;
      physiotherapy service, where exercises are performed to gain strength in muscle groups of the&#xD;
      upper and lower limbs, range of motion, balance and functional movements. The experimental&#xD;
      group will perform the same exercises as the control group, added to a training program using&#xD;
      a bicycle ergometer, with an incremental load (from 60% to 70% of the maximum heart rate) for&#xD;
      20 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 2, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Patients will be included by convenience (according to the inclusion and exclusion criteria) in non-probabilistic form. The included individuals will be randomized by (nome do Sofwate) in two lists: one for the control group and other for the experimental group. Once defined that the patient will be part of the experimental group, a bicycle ergometer will be kept in the patient's accommodation during the period of hospitalization due to restrictions imposed by the Infection Control Department. Thus, the equipment will remain in the patient´s room during the hospitalization, while the other patients will be allocated to the control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lower Limb Physical Functioning and Strength</measure>
    <time_frame>Trough study completion, an average of 2 months</time_frame>
    <description>The 30-Second Chair Stand evaluates lower limb strength and, indirectly, the risk of falls, especially in the elderly population (JONES, J., RIKLI, 2002). This way, it will compose the set of tests used to determine the physical performance by measuring the number of stands from an armless chair of standard height (45 cm) performed in 30 seconds. The test will be begin when the participant, seating on a neutral spine position and feet flat on the floor, will be instructed to rise to a full stand and return to the original seated position, as quickly as possible. The participant will be instructed to move at maximal speed until they either feel the need to stop or the 30-second time limit is reached. More than 8 unassisted stands for men and women are considered above average for their age, and those below the range as below average</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Trough study completion, an average of 2 months</time_frame>
    <description>Piper Fatigue Scale, developed by Piper et al. (1998), is a multidimensional measure of fatigue in the field of cancer research and includes subdomains of the behavioral, affective, sensorial and cognitive attributes / fatigue mood, composed of 22 items. The scores for each item range from 0 to 10 and can total 220 points. Higher values characterize a greater perception of fatigue. It will be applied on patient's evaluation day and on hospital discharge day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms Assessment</measure>
    <time_frame>Trough study completion, an average of 2 months</time_frame>
    <description>The Edmonton Symptom Assessment Scalemorning will be applied to eavaluate symptoms of pain, tiredness, drowsiness, appetite, nausea, shortness of breath, depression, anxiety and well-being. It is a scale where the patient provides an auto-report on a score that can vary from 0 to 10, being score 0 absence of symptoms and 10 represents the most intense sensation experienced by the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and Go (TUG)</measure>
    <time_frame>Trough study completion, an average of 2 months</time_frame>
    <description>TUG is used in clinical practice to assess mobility, the risk of falls and also to assist in the diagnosis of sarcopenia. For this reason, that test will be compiled or set of tests that will be used to determine physical performance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Fatigue</condition>
  <condition>Leukemia</condition>
  <condition>Lymphoma</condition>
  <condition>Multiple Myeloma</condition>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group the exercise program will be based on the protocol of Control Group, without the exception of walking training, adding aerobic capacity training using the bicycle ergometer, model CBL11 Classic® from ACT®.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this group the exercise program is based on the standard physiotherapy protocol that is part of the care routines performed at the bone marrow transplant service.&#xD;
It includes essential components of a rehabilitation program: range of motion, balance training, gait and strength of the upper and lower limbs</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic training with cycle ergometer</intervention_name>
    <description>Patients start with an initial warm-up of 2 minutes, with rotations per minute free, without load. Progressively, the load of the exercise cycle increases every minute up to the supported limit or up to 60% - 70% of maximum heart rate (HRmax). The training will be carried out for 20 continuous minutes, being interrupted whenever the heart rate (HR) reaches 90% of the maximum expected for the age and / or the loss of effort perceived in the BORG scale, above 8 on a scale of 0 to 10.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (18-70 years) scheduled to perform the first HSCT;&#xD;
&#xD;
          -  Be with a preserved neurological function and full cognition;&#xD;
&#xD;
          -  Have clinical conditions that allow participation in the motor physiotherapy program;&#xD;
&#xD;
          -  Be agreed with a study proposal and sign the free and informed consent form (ICF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Develop clinical complications that contraindicate the performance of motor&#xD;
             physiotherapy including the practice of the cycle ergometer;&#xD;
&#xD;
          -  Present a previous musculoskeletal alteration that interferes with the performance of&#xD;
             physical performance assessment tests;&#xD;
&#xD;
          -  Recent cardiovascular or pulmonary disease;&#xD;
&#xD;
          -  Psychiatric or neurological disorder;&#xD;
&#xD;
          -  Need for gait assistance or presence of bone metastasis&#xD;
&#xD;
          -  Adherence below 50% of the total motor physiotherapy protocol.&#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>Fabricio Edler Macagnan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Health Science of Porto Alegre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fabricio Edler Macagnan, PhD</last_name>
    <phone>+55 (51) 3309.8876</phone>
    <email>fabriciom@ufcspa.edu.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90050-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabricio Edler Macagnan, PhD</last_name>
      <phone>+55 (51) 3309.8876</phone>
      <email>fabriciom@ufcspa.edu.br</email>
    </contact>
    <investigator>
      <last_name>Michele Adriane Froelich, Superior</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Health Science of Porto Alegre</investigator_affiliation>
    <investigator_full_name>Fabrício Edler Macagnan</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>Autologous transplant</keyword>
  <keyword>Allogeneic transplant</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Exercise</keyword>
  <keyword>Fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04496011
org study id: TMO 2020
nct id: NCT04496011
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Physiological changes caused by hematological diseases associated with high dose chemotherapy
      have a negative impact on patient's functionality, making them more fragile and vulnerable
      after hematopoietic cell transplantation. Currently, randomized studies have shown that
      physical exercise can contribute to improve Quality of Life of these patients. In this
      randomized controlled trial, we will study the effect of using the bicycle ergometer on the
      physical performance of patients undergoing transplantation of hematopoietic stem cells
      (HSCT).
The sample consists of 30 patients diagnosed with leukemia, lymphoma and multiple myeloma,
      undergoing high-dose chemotherapy and hematopoietic stem cells transplantation, who will be
      randomized into two groups. The results of muscle strength in the lower limbs, general
      mobility, fatigue and clinical symptoms will be compared between the control group and the
      experimental group.

      The control group will perform an exercise program based on the standard protocol of the
      physiotherapy service, where exercises are performed to gain strength in muscle groups of the
      upper and lower limbs, range of motion, balance and functional movements. The experimental
      group will perform the same exercises as the control group, added to a training program using
      a bicycle ergometer, with an incremental load (from 60% to 70% of the maximum heart rate) for
      20 minutes.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Patients will be included by convenience (according to the inclusion and exclusion criteria) in non-probabilistic form. The included individuals will be randomized by (nome do Sofwate) in two lists: one for the control group and other for the experimental group. Once defined that the patient will be part of the experimental group, a bicycle ergometer will be kept in the patient's accommodation during the period of hospitalization due to restrictions imposed by the Infection Control Department. Thus, the equipment will remain in the patient´s room during the hospitalization, while the other patients will be allocated to the control group.
primary purpose: Treatment
masking: None (Open Label)
measure: Lower Limb Physical Functioning and Strength
time frame: Trough study completion, an average of 2 months
description: The 30-Second Chair Stand evaluates lower limb strength and, indirectly, the risk of falls, especially in the elderly population (JONES, J., RIKLI, 2002). This way, it will compose the set of tests used to determine the physical performance by measuring the number of stands from an armless chair of standard height (45 cm) performed in 30 seconds. The test will be begin when the participant, seating on a neutral spine position and feet flat on the floor, will be instructed to rise to a full stand and return to the original seated position, as quickly as possible. The participant will be instructed to move at maximal speed until they either feel the need to stop or the 30-second time limit is reached. More than 8 unassisted stands for men and women are considered above average for their age, and those below the range as below average
measure: Fatigue
time frame: Trough study completion, an average of 2 months
description: Piper Fatigue Scale, developed by Piper et al. (1998), is a multidimensional measure of fatigue in the field of cancer research and includes subdomains of the behavioral, affective, sensorial and cognitive attributes / fatigue mood, composed of 22 items. The scores for each item range from 0 to 10 and can total 220 points. Higher values characterize a greater perception of fatigue. It will be applied on patient's evaluation day and on hospital discharge day.
measure: Symptoms Assessment
time frame: Trough study completion, an average of 2 months
description: The Edmonton Symptom Assessment Scalemorning will be applied to eavaluate symptoms of pain, tiredness, drowsiness, appetite, nausea, shortness of breath, depression, anxiety and well-being. It is a scale where the patient provides an auto-report on a score that can vary from 0 to 10, being score 0 absence of symptoms and 10 represents the most intense sensation experienced by the patient.
measure: Timed up and Go (TUG)
time frame: Trough study completion, an average of 2 months
description: TUG is used in clinical practice to assess mobility, the risk of falls and also to assist in the diagnosis of sarcopenia. For this reason, that test will be compiled or set of tests that will be used to determine physical performance.
arm group label: Experimental Group
arm group type: Experimental
description: In this group the exercise program will be based on the protocol of Control Group, without the exception of walking training, adding aerobic capacity training using the bicycle ergometer, model CBL11 Classic® from ACT®.
arm group label: Group Control
arm group type: No Intervention
description: In this group the exercise program is based on the standard physiotherapy protocol that is part of the care routines performed at the bone marrow transplant service.
It includes essential components of a rehabilitation program: range of motion, balance training, gait and strength of the upper and lower limbs
intervention type: Other
intervention name: Aerobic training with cycle ergometer
description: Patients start with an initial warm-up of 2 minutes, with rotations per minute free, without load. Progressively, the load of the exercise cycle increases every minute up to the supported limit or up to 60% - 70% of maximum heart rate (HRmax). The training will be carried out for 20 continuous minutes, being interrupted whenever the heart rate (HR) reaches 90% of the maximum expected for the age and / or the loss of effort perceived in the BORG scale, above 8 on a scale of 0 to 10.
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Fabricio Edler Macagnan, PhD
role: Principal Investigator
affiliation: Federal University of Health Science of Porto Alegre
last name: Fabricio Edler Macagnan, PhD
phone: +55 (51) 3309.8876
email: fabriciom@ufcspa.edu.br
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Health Science of Porto Alegre
investigator full name: Fabrício Edler Macagnan
investigator title: Sponsor-Investigator
mesh term: Multiple Myeloma
mesh term: Fatigue
sharing ipd: No