<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/NCT03016416</url>
  </required_header>
  <id_info>
    <org_study_id>0063-16-COM</org_study_id>
    <nct_id>NCT03016416</nct_id>
  </id_info>
  <brief_title>The Influence of Rhythm, Cognitive Task and Physical Activity on the Cardiac ANS in Chronic Stroke Patients</brief_title>
  <official_title>The Influence of Rhythm, Cognitive Task and Physical Activity on the Cardiac Autonomic Nerve System in Chronic Stroke Patients and in a Control Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clalit Health Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clalit Health Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Autonomic dysfunction is a common complication of stroke that may lead to poor rehabilitation&#xD;
      outcomes and to increase in mortality. The severity of the autonomic dysfunction can be&#xD;
      measured in many ways, but the most common way is assessment of the&#xD;
      sympathetic-parasympathetic equilibrium by heart rate variability analysis. It is known that&#xD;
      the plasticity of the brain can influence the autonomic nerve system and that providing&#xD;
      appropriate stimuli encourages these changes. It was found that stimulation of rhythm,&#xD;
      stimulation of cognitive tasks and stimulation of activity, influence the autonomic nerve&#xD;
      system in healthy subjects. Thus, we can ask if an integrated task (activity, cognitive,&#xD;
      rhythm) may influence the autonomic nervous system and cause an increase in brain activity,&#xD;
      therefore contributing to the rehabilitation of stroke patients. Taken together, the purpose&#xD;
      of this study is to examine the influence of stimulation of rhythm, stimulation of cognition,&#xD;
      stimulation of activity and combined stimulation, on the autonomic nerve system. This effect&#xD;
      will be tested by measuring heart rate variability in chronic stroke patients and in a&#xD;
      control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      background and Rationale: Autonomic dysfunction is a common complication of stroke that may&#xD;
      lead to poor rehabilitation outcomes and to increase in mortality. Although this dysfunction&#xD;
      is a common symptom of stroke, both in the acute phase and in the chronic phase, it is not a&#xD;
      specific therapeutic target yet. The severity of the autonomic dysfunction can be measured in&#xD;
      many ways, but the most common way is assessment of the sympathetic-parasympathetic&#xD;
      equilibrium by heart rate variability analysis. It is known that the plasticity of the brain&#xD;
      can influence the autonomic nerve system and that providing appropriate stimuli encourages&#xD;
      these changes. It was found that stimulation of rhythm, stimulation of cognitive tasks (in&#xD;
      particular, stimulation of executive functions) and stimulation of activity, influence the&#xD;
      autonomic nerve system in healthy subjects. Thus, we can ask if an integrated task (activity,&#xD;
      cognitive, rhythm) may influence the autonomic nervous system and cause an increase in brain&#xD;
      activity, therefore contributing to the rehabilitation of stroke patients. Taken together,&#xD;
      the purpose of this study is to examine the influence of stimulation of rapid or slow rhythm,&#xD;
      stimulation of cognition by cognitive tasks, stimulation of activity by pedaling a fitness&#xD;
      bike and combined stimulation, on the autonomic nerve system. This effect will be tested by&#xD;
      measuring heart rate variability in chronic stroke patients and in a control group with&#xD;
      equivalent age and lifestyle.&#xD;
&#xD;
      The Medical Device:&#xD;
&#xD;
      Heart rate and heart rate variability will be monitored by Polar RS800CX watch (PolarElectro&#xD;
      OY, Kempele, Finland(. A transmitter placed on the patient's chest will collect the data.&#xD;
      This data will be stored in the watch's computer and then analyzed in a specific Polar&#xD;
      software (Polar Protrainer 5 inc.). An appropriate filtration will be made after a&#xD;
      preliminary study. Pedaling capability, RPM, will be collected from cadence sensor with&#xD;
      Bluetooth smart.&#xD;
&#xD;
      The Purpose of this Medical Research:&#xD;
&#xD;
      The purpose of this study is to examine the influence of stimulation of rapid or slow rhythm,&#xD;
      stimulation of cognition by cognitive tasks, stimulation of activity by pedaling a fitness&#xD;
      bike and combined stimulation, on the autonomic nerve system in chronic stroke patients and&#xD;
      in a control group with equivalent age and lifestyle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>90 min</time_frame>
    <description>Heart rate variability will be monitored by Polar RS800CX watch (PolarElectro OY, Kempele, Finland). A transmitter put on the patient's chest will collect the data. This data will be stored in the watch's computer and then analyzed in a specific Polar software (Polar Protrainer 5 inc.). An appropriate filtration will be made after a preliminary study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pedaling capability</measure>
    <time_frame>25 min</time_frame>
    <description>Pedaling capability, rpm, will be collected from cadence sensor with Bluetooth smart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive outcomes</measure>
    <time_frame>10 min task</time_frame>
    <description>Cognitive outcomes will be evaluated by Digit Span, a sub section of Wechsler Adult Intelligence test (Choi et al., 2014).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Unrecognized Condition</condition>
  <arm_group>
    <arm_group_label>chronic stroke patients</arm_group_label>
    <description>Participants for the study group will be recruited from the Clalit Health Services- Ben Yair Rehabilitation Center in Jaffa Israel.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>The control group will be with equivalent age and lifestyle as the studt group. Participants for the control group will be recruited via solicitation adds at the Ben Yair Rehabilitation Center and at near-by clinics.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The research will include two study groups, each with 16 participants. Participants in the&#xD;
        study group will include 16 patients after first ischemic stroke, one sided, in the chronic&#xD;
        phase.&#xD;
&#xD;
          -  Participants in the control group will include 16 healthy adults with equivalent age&#xD;
             and lifestyle and without stroke history.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants will be &gt; 60 years, have Clalit health insurance, walking and Hebrew&#xD;
             native speakers. Number of man and woman participating in the study will be equal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with any of the following criteria will not participate in the study:&#xD;
             participants with communication problems such as language, hearing or visual problems,&#xD;
             recurrent strokes, cognitive deficiency (MoCA≤ 26) (Toglia et al., 2011), neglect by&#xD;
             BIT - Star cancellation test (Wilsonet et al., 1987), patients with central or&#xD;
             peripheral neurological problems, heart pacemaker and/or patients that use medications&#xD;
             that effect the autonomic nerve system such asβ blockers, or use alcohol or drugs.&#xD;
&#xD;
          -  Patients that suffer from background illness that can effect their ability to cycle&#xD;
             such as knee OA.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 25, 2016</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 8, 2017</last_update_submitted>
  <last_update_submitted_qc>January 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clalit Health Services</investigator_affiliation>
    <investigator_full_name>Alon Erez</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <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/NCT03016416
org study id: 0063-16-COM
nct id: NCT03016416
lead sponsor: 
has dmc: No
Autonomic dysfunction is a common complication of stroke that may lead to poor rehabilitation
      outcomes and to increase in mortality. The severity of the autonomic dysfunction can be
      measured in many ways, but the most common way is assessment of the
      sympathetic-parasympathetic equilibrium by heart rate variability analysis. It is known that
      the plasticity of the brain can influence the autonomic nerve system and that providing
      appropriate stimuli encourages these changes. It was found that stimulation of rhythm,
      stimulation of cognitive tasks and stimulation of activity, influence the autonomic nerve
      system in healthy subjects. Thus, we can ask if an integrated task (activity, cognitive,
      rhythm) may influence the autonomic nervous system and cause an increase in brain activity,
      therefore contributing to the rehabilitation of stroke patients. Taken together, the purpose
      of this study is to examine the influence of stimulation of rhythm, stimulation of cognition,
      stimulation of activity and combined stimulation, on the autonomic nerve system. This effect
      will be tested by measuring heart rate variability in chronic stroke patients and in a
      control group.
background and Rationale: Autonomic dysfunction is a common complication of stroke that may
      lead to poor rehabilitation outcomes and to increase in mortality. Although this dysfunction
      is a common symptom of stroke, both in the acute phase and in the chronic phase, it is not a
      specific therapeutic target yet. The severity of the autonomic dysfunction can be measured in
      many ways, but the most common way is assessment of the sympathetic-parasympathetic
      equilibrium by heart rate variability analysis. It is known that the plasticity of the brain
      can influence the autonomic nerve system and that providing appropriate stimuli encourages
      these changes. It was found that stimulation of rhythm, stimulation of cognitive tasks (in
      particular, stimulation of executive functions) and stimulation of activity, influence the
      autonomic nerve system in healthy subjects. Thus, we can ask if an integrated task (activity,
      cognitive, rhythm) may influence the autonomic nervous system and cause an increase in brain
      activity, therefore contributing to the rehabilitation of stroke patients. Taken together,
      the purpose of this study is to examine the influence of stimulation of rapid or slow rhythm,
      stimulation of cognition by cognitive tasks, stimulation of activity by pedaling a fitness
      bike and combined stimulation, on the autonomic nerve system. This effect will be tested by
      measuring heart rate variability in chronic stroke patients and in a control group with
      equivalent age and lifestyle.

      The Medical Device:

      Heart rate and heart rate variability will be monitored by Polar RS800CX watch (PolarElectro
      OY, Kempele, Finland(. A transmitter placed on the patient's chest will collect the data.
      This data will be stored in the watch's computer and then analyzed in a specific Polar
      software (Polar Protrainer 5 inc.). An appropriate filtration will be made after a
      preliminary study. Pedaling capability, RPM, will be collected from cadence sensor with
      Bluetooth smart.

      The Purpose of this Medical Research:

      The purpose of this study is to examine the influence of stimulation of rapid or slow rhythm,
      stimulation of cognition by cognitive tasks, stimulation of activity by pedaling a fitness
      bike and combined stimulation, on the autonomic nerve system in chronic stroke patients and
      in a control group with equivalent age and lifestyle.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Heart rate variability
time frame: 90 min
description: Heart rate variability will be monitored by Polar RS800CX watch (PolarElectro OY, Kempele, Finland). A transmitter put on the patient's chest will collect the data. This data will be stored in the watch's computer and then analyzed in a specific Polar software (Polar Protrainer 5 inc.). An appropriate filtration will be made after a preliminary study.
measure: Pedaling capability
time frame: 25 min
description: Pedaling capability, rpm, will be collected from cadence sensor with Bluetooth smart
measure: Cognitive outcomes
time frame: 10 min task
description: Cognitive outcomes will be evaluated by Digit Span, a sub section of Wechsler Adult Intelligence test (Choi et al., 2014).
arm group label: chronic stroke patients
description: Participants for the study group will be recruited from the Clalit Health Services- Ben Yair Rehabilitation Center in Jaffa Israel.
arm group label: control group
description: The control group will be with equivalent age and lifestyle as the studt group. Participants for the control group will be recruited via solicitation adds at the Ben Yair Rehabilitation Center and at near-by clinics.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Clalit Health Services
investigator full name: Alon Erez
investigator title: Doctor
sharing ipd: No