xml: <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/NCT06038383</url>
    </required_header>
    <id_info>
      <org_study_id>5.802.024</org_study_id>
      <nct_id>NCT06038383</nct_id>
    </id_info>
    <brief_title>Effect of Physical Exercise Performed Through Virtual Reality Games on Chronic Renal Patients During Hemodialysis</brief_title>
    <official_title>Effect of Physical Exercise Performed Through Virtual Reality Games on the Modulation of Heart Rate Variability in Chronic Renal Patients During Hemodialysis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Sao Paulo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Federal University of São Paulo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Sao Paulo</source>
    <oversight_info>
      <has_dmc>No</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>
        Patients with chronic kidney diseases, especially those requiring hemodialysis, are&#xD;
        characterized by an increased risk of numerous morbidities. This is a condition that&#xD;
        significantly impacts the patient's quality of life, leads to dependence, and involves&#xD;
        high-cost treatment. The physical condition of chronic kidney disease patients falls well&#xD;
        below the recommendations set by the World Health Organization, indicating effective&#xD;
        difficulties in the approaches used for implementing physical activity programs. New&#xD;
        approaches must be considered. Physical activity through virtual reality can foster greater&#xD;
        social integration of patients with physical exercise during hemodialysis, enabling improved&#xD;
        quality of life and decreased frailty levels for these individuals due to its playful and&#xD;
        motivational nature.&#xD;
  &#xD;
        Objective: To assess changes in heart rate variability modulation and the quality of life of&#xD;
        chronic kidney disease patients undergoing virtual reality-based exercise during hemodialysis&#xD;
        sessions.&#xD;
  &#xD;
        Methods: A longitudinal, controlled, randomized crossover clinical trial. The chronic kidney&#xD;
        disease groups will be divided into two groups, Group A (GA) and Group B (GB). Group GA will&#xD;
        engage in 10 interventions, with each intervention involving the completion of 3 sessions of&#xD;
        a Virtual Reality (VR) game lasting 5 minutes each, totaling 15 minutes of exercise. Group GB&#xD;
        will participate in 10 interventions, with each intervention comprising 15 minutes of&#xD;
        physical exercise on a cycle ergometer, referred to here as conventional exercise.&#xD;
  &#xD;
        After the initial 10 interventions, the groups will switch exercises; that is, GA will cease&#xD;
        VR interventions and begin another 10 interventions with conventional exercise, while GB will&#xD;
        stop conventional exercise interventions and start another 10 interventions with VR.&#xD;
  &#xD;
        The Kidney Disease Quality of Life Short Form questionnaire, Beck's Anxiety and Depression&#xD;
        Inventory, and the International Physical Activity Questionnaire will also be administered to&#xD;
        all groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this Longitudinal CrossOver Clinical Trial is to compare changes in heart&#xD;
        rate variability modulation in chronic renal patients undergoing conventional physical&#xD;
        exercise and in a virtual environment during hemodialysis sessions.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
        What are the differences in changes in heart rate variability modulation between chronic&#xD;
        renal patients who undergo conventional physical exercise before and during hemodialysis&#xD;
        sessions, and those who engage in virtual environment exercises?&#xD;
  &#xD;
        How does the virtual environment influence changes in heart rate variability modulation&#xD;
        compared to conventional physical exercise in chronic renal patients before and during&#xD;
        hemodialysis sessions?&#xD;
  &#xD;
        What is the relative effectiveness of conventional physical exercise compared to virtual&#xD;
        environment exercise in improving heart rate variability modulation in chronic renal patients&#xD;
        before and during hemodialysis sessions?&#xD;
  &#xD;
        Group A will participate in 10 interventions, each intervention consisting of playing 3&#xD;
        rounds of a Virtual Reality game lasting 5 minutes, totaling 15 minutes of exercise. Group B&#xD;
        will participate in 10 interventions, each intervention consisting of 15 minutes of physical&#xD;
        exercise on a cycle ergometer, referred to here as conventional exercise.&#xD;
  &#xD;
        After the initial 10 interventions,there will be a 1-week washout period and the groups will&#xD;
        switch exercises. Heart rate and respiratory rate, oxygen saturation, systemic blood&#xD;
        pressure, laboratory tests, as well as the Kidney Disease Quality of Life Short Form&#xD;
        questionnaire, the Beck Anxiety and Depression Inventory, and the International Physical&#xD;
        Activity Questionnaire will be assessed in all groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Heart Rate Variability behavior during interventions with Virtual Reality and Stationary Bike while in hemodialysis.</measure>
      <time_frame>4 days</time_frame>
      <description>Measurements made by heart rate variability indices, using both linear and non-linear measurements, using a chest trap that captures the R-R intervals in milliseconds.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood pressure during interventions with Virtual Reality and Stationary Bike while in hemodialysis</measure>
      <time_frame>20 days</time_frame>
      <description>Measurements made by blood pressure in mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis</measure>
      <time_frame>20 days</time_frame>
      <description>Measurements made by heart rate in beats per minute.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis</measure>
      <time_frame>20 days</time_frame>
      <description>Measurements made by respiratory rate in incursions per minute.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxygen saturation during interventions with Virtual Reality and Stationary Bike while in hemodialysis</measure>
      <time_frame>20 days</time_frame>
      <description>Measurements made by oxygen saturation in percentage.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Renal Insufficiency, Chronic</condition>
    <arm_group>
      <arm_group_label>Group A - Intervention with Virtual Reality (VR)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group of people with kidney disease that enrolled the intervention with VR during hemodialysis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B - Intervention with Stationary Bike (SB)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group of people with kidney disease that enrolled the intervention with SB during hemodialysis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group A - Intervention with Stationary Bike (SB) - Crossover</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group of people with kidney disease that enrolled the intervention with SB during hemodialysis, after the period of washout.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B - Intervention with Virtual Reality (VR) - Crossover</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group of people with kidney disease that enrolled the intervention with VR during hemodialysis, after the period of washout.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Group A - Intervention with Virtual Reality (VR)</intervention_name>
      <description>Group of people with kidney disease that performed VR intervention during hemodialysis.</description>
      <arm_group_label>Group A - Intervention with Virtual Reality (VR)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Group B - Intervention with Stationary Bike (SB)</intervention_name>
      <description>Group of people with kidney disease that performed SB intervention during hemodialysis.</description>
      <arm_group_label>Group B - Intervention with Stationary Bike (SB)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Group A - Intervention with Stationary Bike (SB) - Crossover</intervention_name>
      <description>Group of people with kidney disease that performed SB intervention during hemodialysis after the washout period.</description>
      <arm_group_label>Group A - Intervention with Stationary Bike (SB) - Crossover</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Group B - Intervention with Virtual Reality (VR) - Crossover</intervention_name>
      <description>Group of people with kidney disease that performed VR intervention during hemodialysis after the washout period.</description>
      <arm_group_label>Group B - Intervention with Virtual Reality (VR) - Crossover</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with diagnosed chronic renal insufficiency requiring hemodialysis at any&#xD;
               classification level.&#xD;
  &#xD;
            -  Age over 18 years.&#xD;
  &#xD;
            -  Possession of medical clearance for participating in physical exercise.&#xD;
  &#xD;
            -  Ability for lower limb movement without affecting dialysis treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute use of medications that affect the cardiovascular system and/or alter the&#xD;
               function of the nervous system, unless they are part of the disease treatment protocol&#xD;
               and are part of the patient's routine.&#xD;
  &#xD;
            -  Reports of persistent pain and fatigue arising after the start of exercise training.&#xD;
  &#xD;
            -  Changes in the type of renal treatment during the protocol application period.&#xD;
  &#xD;
            -  Absence from three consecutive exercise training sessions.&#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>Talita D Silva, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Federal University of São Paulo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jacqueline C Macedo-Dias, Masters</last_name>
      <phone>+5515991929494</phone>
      <email>jacqueline.macedo@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Talita D Silva, PhD</last_name>
      <phone>+5511998590188</phone>
      <email>ft.talitadias@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Comitê de Etica da Universidade Federal de São Paulo</name>
        <address>
          <city>São Paulo</city>
          <zip>04.023-900</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Miguel Jorge</last_name>
        <phone>+55(11)55711062</phone>
        <email>cep@unifesp.br</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
      <investigator_full_name>Talita Dias da Silva</investigator_full_name>
      <investigator_title>Researcher</investigator_title>
    </responsible_party>
    <keyword>hemodialysis</keyword>
    <keyword>physical exercise</keyword>
    <keyword>virtual reality</keyword>
    <keyword>Renal Insufficiency</keyword>
    <keyword>heart rate variability</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Renal Insufficiency</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038383
  org study id: 5.802.024
  nct id: NCT06038383
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients with chronic kidney diseases, especially those requiring hemodialysis, are
        characterized by an increased risk of numerous morbidities. This is a condition that
        significantly impacts the patient's quality of life, leads to dependence, and involves
        high-cost treatment. The physical condition of chronic kidney disease patients falls well
        below the recommendations set by the World Health Organization, indicating effective
        difficulties in the approaches used for implementing physical activity programs. New
        approaches must be considered. Physical activity through virtual reality can foster greater
        social integration of patients with physical exercise during hemodialysis, enabling improved
        quality of life and decreased frailty levels for these individuals due to its playful and
        motivational nature.
  
        Objective: To assess changes in heart rate variability modulation and the quality of life of
        chronic kidney disease patients undergoing virtual reality-based exercise during hemodialysis
        sessions.
  
        Methods: A longitudinal, controlled, randomized crossover clinical trial. The chronic kidney
        disease groups will be divided into two groups, Group A (GA) and Group B (GB). Group GA will
        engage in 10 interventions, with each intervention involving the completion of 3 sessions of
        a Virtual Reality (VR) game lasting 5 minutes each, totaling 15 minutes of exercise. Group GB
        will participate in 10 interventions, with each intervention comprising 15 minutes of
        physical exercise on a cycle ergometer, referred to here as conventional exercise.
  
        After the initial 10 interventions, the groups will switch exercises; that is, GA will cease
        VR interventions and begin another 10 interventions with conventional exercise, while GB will
        stop conventional exercise interventions and start another 10 interventions with VR.
  
        The Kidney Disease Quality of Life Short Form questionnaire, Beck's Anxiety and Depression
        Inventory, and the International Physical Activity Questionnaire will also be administered to
        all groups.
  The objective of this Longitudinal CrossOver Clinical Trial is to compare changes in heart
        rate variability modulation in chronic renal patients undergoing conventional physical
        exercise and in a virtual environment during hemodialysis sessions.
  
        The main questions it aims to answer are:
  
        What are the differences in changes in heart rate variability modulation between chronic
        renal patients who undergo conventional physical exercise before and during hemodialysis
        sessions, and those who engage in virtual environment exercises?
  
        How does the virtual environment influence changes in heart rate variability modulation
        compared to conventional physical exercise in chronic renal patients before and during
        hemodialysis sessions?
  
        What is the relative effectiveness of conventional physical exercise compared to virtual
        environment exercise in improving heart rate variability modulation in chronic renal patients
        before and during hemodialysis sessions?
  
        Group A will participate in 10 interventions, each intervention consisting of playing 3
        rounds of a Virtual Reality game lasting 5 minutes, totaling 15 minutes of exercise. Group B
        will participate in 10 interventions, each intervention consisting of 15 minutes of physical
        exercise on a cycle ergometer, referred to here as conventional exercise.
  
        After the initial 10 interventions,there will be a 1-week washout period and the groups will
        switch exercises. Heart rate and respiratory rate, oxygen saturation, systemic blood
        pressure, laboratory tests, as well as the Kidney Disease Quality of Life Short Form
        questionnaire, the Beck Anxiety and Depression Inventory, and the International Physical
        Activity Questionnaire will be assessed in all groups.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Heart Rate Variability behavior during interventions with Virtual Reality and Stationary Bike while in hemodialysis.
  time frame: 4 days
  description: Measurements made by heart rate variability indices, using both linear and non-linear measurements, using a chest trap that captures the R-R intervals in milliseconds.
  measure: Blood pressure during interventions with Virtual Reality and Stationary Bike while in hemodialysis
  time frame: 20 days
  description: Measurements made by blood pressure in mmHg
  measure: Heart rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
  time frame: 20 days
  description: Measurements made by heart rate in beats per minute.
  measure: Respiratory rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
  time frame: 20 days
  description: Measurements made by respiratory rate in incursions per minute.
  measure: Oxygen saturation during interventions with Virtual Reality and Stationary Bike while in hemodialysis
  time frame: 20 days
  description: Measurements made by oxygen saturation in percentage.
  arm group label: Group A - Intervention with Virtual Reality (VR)
  arm group type: Experimental
  description: Group of people with kidney disease that enrolled the intervention with VR during hemodialysis.
  arm group label: Group B - Intervention with Stationary Bike (SB)
  arm group type: Active Comparator
  description: Group of people with kidney disease that enrolled the intervention with SB during hemodialysis.
  arm group label: Group A - Intervention with Stationary Bike (SB) - Crossover
  arm group type: Experimental
  description: Group of people with kidney disease that enrolled the intervention with SB during hemodialysis, after the period of washout.
  arm group label: Group B - Intervention with Virtual Reality (VR) - Crossover
  arm group type: Active Comparator
  description: Group of people with kidney disease that enrolled the intervention with VR during hemodialysis, after the period of washout.
  intervention type: Device
  intervention name: Group A - Intervention with Virtual Reality (VR)
  description: Group of people with kidney disease that performed VR intervention during hemodialysis.
  arm group label: Group A - Intervention with Virtual Reality (VR)
  intervention type: Device
  intervention name: Group B - Intervention with Stationary Bike (SB)
  description: Group of people with kidney disease that performed SB intervention during hemodialysis.
  arm group label: Group B - Intervention with Stationary Bike (SB)
  intervention type: Device
  intervention name: Group A - Intervention with Stationary Bike (SB) - Crossover
  description: Group of people with kidney disease that performed SB intervention during hemodialysis after the washout period.
  arm group label: Group A - Intervention with Stationary Bike (SB) - Crossover
  intervention type: Device
  intervention name: Group B - Intervention with Virtual Reality (VR) - Crossover
  description: Group of people with kidney disease that performed VR intervention during hemodialysis after the washout period.
  arm group label: Group B - Intervention with Virtual Reality (VR) - Crossover
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Talita D Silva, PhD
  role: Principal Investigator
  affiliation: Federal University of São Paulo
  last name: Jacqueline C Macedo-Dias, Masters
  phone: +5515991929494
  email: jacqueline.macedo@gmail.com
  last name: Talita D Silva, PhD
  phone: +5511998590188
  email: ft.talitadias@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: University of Sao Paulo
  investigator full name: Talita Dias da Silva
  investigator title: Researcher
  mesh term: Renal Insufficiency
  mesh term: Renal Insufficiency, Chronic
  sharing ipd: No