<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/NCT02999360</url>
  </required_header>
  <id_info>
    <org_study_id>16-00960</org_study_id>
    <nct_id>NCT02999360</nct_id>
  </id_info>
  <brief_title>Aerobic Exercise and Aphasia Treatment</brief_title>
  <official_title>Aerobic Exercise and Aphasia Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      The purpose of the study is to determine if speech therapy can be enhanced by Aerobic&#xD;
      Exercise (AE). Investigators will use a single subject design to determine if aphasia therapy&#xD;
      result in greater gains when combined with aerobic exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: To test the feasibility of a research study that combines speech therapy with aerobic&#xD;
      exercise (AE). Participants will be alternately assigned to receiving AE during during a 30&#xD;
      minute break from speech therapy.&#xD;
&#xD;
      Aim 2: To test the preliminary efficacy of combining speech therapy with AE to promote&#xD;
      language improvements in aphasia. These data will inform the design of a large, controlled&#xD;
      clinical trial&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 19, 2016</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Actual">September 20, 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Aphasia Communication Outcome Measure (ACOM) (Hula et al., 2015)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Patient-reported outcome measure of communicative functioning for persons with aphasia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Boston Naming Test</measure>
    <time_frame>24 Weeks</time_frame>
    <description>The examiner begins with Item 1 and continues through Item 60, unless the patient is in distress or refuses to continue. The patient is told to tell the examiner the name of each picture and is given about 20 seconds to respond for each trial. The examiner writes down the patient's responses in detail, using codes. If the patient fails to give the correct response, the examiner at her or his discretion may give the patient a phonemic cue, which is the initial sound of the target word. After the patient completes the test, the examiner scores each item + or - according to the response coding and scoring procedures</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Aphasia</condition>
  <arm_group>
    <arm_group_label>Treatment 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Language therapy</intervention_name>
    <description>There will be three blocks of treatment, ideally three times a week 100 minutes per day. Treatment will target impairment-directed speech language therapy (SLT) approaches or compensatory-directed SLT in each of the three treatment blocks. Half of the participants will receive the impairment-directed SLT. Half of the participants, will receive treatment that will target compensatory-directed speech language therapy approaches that are focused on functional communication skills in the conversational context. Methods of treatment will include PACE (Promoting Aphasics Communicative Effectiveness (Davis, 2005), conversational coaching (Hopper et al., 2002), and supported conversation (Kagan et al., 2001). The clinician will model and encourage all (verbal and non verbal) modalities of communication.</description>
    <arm_group_label>Treatment 1</arm_group_label>
    <arm_group_label>Treatment 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Background Music</intervention_name>
    <description>30 minutes background music only</description>
    <arm_group_label>Treatment 1</arm_group_label>
    <arm_group_label>Treatment 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic Exercise</intervention_name>
    <description>There will be three blocks of treatment and the AE will take place for all participants during one or two treatment blocks (randomly assigned), threetimes a week (sessions are three times a week prior to speech therapy but may be one or two times a week if a session is missed or may be up to four or five times a week if one or two sessions are missed and rescheduled due to weather or other circumstances).</description>
    <arm_group_label>Treatment 1</arm_group_label>
    <arm_group_label>Treatment 2</arm_group_label>
    <other_name>AE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aphasia severity based on Western Aphasia Battery-Revised (WAB-R) aphasia&#xD;
             quotient(AQ)&gt;50. An AQ of 51-75 correlates to moderate aphasia severity and an AQ of&#xD;
             76 and above correlates to mild aphasia severity. Only participants with mild to&#xD;
             moderate aphasia (WAB AQ&gt;50) will be included. The Aphasia Quotient (AQ) is an&#xD;
             essential summary value of the individual's aphasic deficit and is proportional to the&#xD;
             severity of aphasia regardless of the type of aphasia or etiology of aphasia. Type of&#xD;
             aphasia is not an inclusionary/exclusionary criterion because the focus is on language&#xD;
             recovery regardless of aphasia type.&#xD;
&#xD;
          -  The inclusionary criterion regarding etiology is aphasia post ischemic stroke; no&#xD;
             specific location of stroke is required.&#xD;
&#xD;
          -  Associated cognitive deficits are not a part of the inclusionary/exclusionary criteria&#xD;
             because aphasia is a language disorder and the treatment is a language treatment.&#xD;
&#xD;
          -  English is primary language (patient report). Participant may have exposure to another&#xD;
             language however English is the native language and primary language used for&#xD;
             communication premorbidly.&#xD;
&#xD;
          -  At least 9 months post CVA (patient report and confirmed by medical records review&#xD;
             when records available). The participant must be at least 9 months post stroke, which&#xD;
             is considered to be the chronic stage therefore there is no restriction on the maximum&#xD;
             number of months/years post stroke.&#xD;
&#xD;
          -  Able to participate in AE based on MD screening that follows recommendations for&#xD;
             exercise in stroke patients .&#xD;
&#xD;
          -  Have a history of only one stroke.&#xD;
&#xD;
          -  Independent in walking (with or without assistive device).&#xD;
&#xD;
          -  Medically stable.&#xD;
&#xD;
          -  No previous myocardial infarction.&#xD;
&#xD;
          -  No significant musculo-skeletal problems from conditions other than stroke.&#xD;
&#xD;
          -  History taken by MD and is part of practices standard of care/best practice for&#xD;
             physicians interviewing patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MD considers participant unable to comply with study requirements.&#xD;
&#xD;
          -  MD evaluates medication history and determines if current medications will have a&#xD;
             negative impact and if so MD will not recommend patient inclusion.&#xD;
&#xD;
          -  Mood will first be screened by the Beck Depression Inventory screen and then assessed&#xD;
             with the Beck Depression Inventory (BDI) if the participant does not pass the&#xD;
             screening. This is a 21-item self-report assessment designed specifically to identify&#xD;
             depression. The items are scored 0 (no problem) to 3. Thus, the possible score is&#xD;
             between 0 - 63. A score of 9 or lower is the usual threshold to separate depressed&#xD;
             from non-depressed subjects. If a subject scores 10 or higher the subject will not be&#xD;
             included in the study and the MD will discuss with the subject the possibility of a&#xD;
             referral for a psychiatric evaluation.&#xD;
&#xD;
          -  Stroke due to intracranial hemorrhage primarily due to bleeding from ruptured aneurysm&#xD;
             or arteriovenous malformation.&#xD;
&#xD;
          -  Progressive stroke (primary progressive aphasia diagnosis)&#xD;
&#xD;
          -  Comorbid neurological diagnosis (e.g. MS, PD, dementia)&#xD;
&#xD;
          -  Unable to perform the required exercises due to a) medical, b) musculo-skeletal, or c)&#xD;
             neurological problems (for details see below, a-c)&#xD;
&#xD;
               1. medical problems: unstable cardiovascular condition, or other serious cardiac&#xD;
                  conditions (for example, anyone meeting New York Heart Association Class IV&#xD;
                  criteria, hospitalization for myocardial infarction or heart surgery within 120&#xD;
                  days, severe cardiomyopathy or documented serious and unstable cardiac&#xD;
                  arrhythmias)&#xD;
&#xD;
               2. musculo-skeletal problems: restricted passive range of motion in the major lower&#xD;
                  limb joints (that is, an extension deficit of &gt;20° for the affected hip or knee&#xD;
                  joints, or a dorsiflexion deficit of &gt;20° for the affected ankle)&#xD;
&#xD;
               3. neurological problems: severity of stroke-related deficits Required help of at&#xD;
                  least 1 person to walk before stroke due to neurological (for example, advanced&#xD;
                  Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis) or&#xD;
                  non-neurological (for example, heart failure, orthopaedic problems)&#xD;
                  co-morbidities with life expectancy of less than 1 year as determined by&#xD;
                  physician.&#xD;
&#xD;
          -  Drug or alcohol addiction within the last 6 months.&#xD;
&#xD;
          -  Significant current psychiatric illness defined as affective disorder unresponsive to&#xD;
             medication or bipolar affective disorder, psychosis, schizophrenia or suicidality.&#xD;
&#xD;
          -  Current participation in another interventional trial.&#xD;
&#xD;
        Vulnerable Subjects&#xD;
&#xD;
          -  People in this study will have mild to moderate aphasia. Although they have language&#xD;
             problems aphasia is not an intellectual disorder and patient's aphasia will not be&#xD;
             severe. Subjects will have the capacity to consent to participate.&#xD;
&#xD;
        ed deficits Required help of at least 1 person to walk before stroke due to neurological&#xD;
        (for example, advanced Parkinson's disease, amyotrophic lateral sclerosis, multiple&#xD;
        sclerosis) or non-neurological (for example, heart failure, orthopaedic problems)&#xD;
        co-morbidities with life expectancy of less than 1 year as determined by physician.&#xD;
&#xD;
          -  Drug or alcohol addiction within the last 6 months.&#xD;
&#xD;
          -  Significant current psychiatric illness defined as affective disorder unresponsive to&#xD;
             medication or bipolar affective disorder, psychosis, schizophrenia or suicidality.&#xD;
&#xD;
          -  Current participation in another interventional trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Galletta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aphasia</keyword>
  <keyword>Speech Therapy</keyword>
  <keyword>Aerobic Exercise (AE)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02999360
org study id: 16-00960
nct id: NCT02999360
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to determine if speech therapy can be enhanced by Aerobic
      Exercise (AE). Investigators will use a single subject design to determine if aphasia therapy
      result in greater gains when combined with aerobic exercise.
Aim 1: To test the feasibility of a research study that combines speech therapy with aerobic
      exercise (AE). Participants will be alternately assigned to receiving AE during during a 30
      minute break from speech therapy.

      Aim 2: To test the preliminary efficacy of combining speech therapy with AE to promote
      language improvements in aphasia. These data will inform the design of a large, controlled
      clinical trial
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The Aphasia Communication Outcome Measure (ACOM) (Hula et al., 2015)
time frame: 24 Weeks
description: Patient-reported outcome measure of communicative functioning for persons with aphasia
measure: The Boston Naming Test
time frame: 24 Weeks
description: The examiner begins with Item 1 and continues through Item 60, unless the patient is in distress or refuses to continue. The patient is told to tell the examiner the name of each picture and is given about 20 seconds to respond for each trial. The examiner writes down the patient's responses in detail, using codes. If the patient fails to give the correct response, the examiner at her or his discretion may give the patient a phonemic cue, which is the initial sound of the target word. After the patient completes the test, the examiner scores each item + or - according to the response coding and scoring procedures
arm group label: Treatment 1
arm group type: Experimental
arm group label: Treatment 2
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Language therapy
description: There will be three blocks of treatment, ideally three times a week 100 minutes per day. Treatment will target impairment-directed speech language therapy (SLT) approaches or compensatory-directed SLT in each of the three treatment blocks. Half of the participants will receive the impairment-directed SLT. Half of the participants, will receive treatment that will target compensatory-directed speech language therapy approaches that are focused on functional communication skills in the conversational context. Methods of treatment will include PACE (Promoting Aphasics Communicative Effectiveness (Davis, 2005), conversational coaching (Hopper et al., 2002), and supported conversation (Kagan et al., 2001). The clinician will model and encourage all (verbal and non verbal) modalities of communication.
arm group label: Treatment 1
arm group label: Treatment 2
intervention type: Behavioral
intervention name: Background Music
description: 30 minutes background music only
arm group label: Treatment 1
arm group label: Treatment 2
intervention type: Behavioral
intervention name: Aerobic Exercise
description: There will be three blocks of treatment and the AE will take place for all participants during one or two treatment blocks (randomly assigned), threetimes a week (sessions are three times a week prior to speech therapy but may be one or two times a week if a session is missed or may be up to four or five times a week if one or two sessions are missed and rescheduled due to weather or other circumstances).
arm group label: Treatment 1
arm group label: Treatment 2
other name: AE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Elizabeth Galletta, MD
role: Principal Investigator
affiliation: NYU Langone Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Aphasia
sharing ipd: Undecided