<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/NCT04446455</url>
  </required_header>
  <id_info>
    <org_study_id>3014</org_study_id>
    <nct_id>NCT04446455</nct_id>
  </id_info>
  <brief_title>A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention</brief_title>
  <official_title>A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Boston Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Boston Healthcare System</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 goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in&#xD;
      Veterans 65 years and older. This study will also examine the neuromuscular and cognitive&#xD;
      attributes that contribute to clinically meaningful improvements in mobility; and determine&#xD;
      whether a novel mode of cognitive training can enhance cognition among mobility limited&#xD;
      primary care Veterans 65 years and older.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized control pilot study. All participants will receive rehabilitative&#xD;
      exercise addressing mobility skills. In addition, one group will be will receive additional&#xD;
      cognitive training. Randomization is stratified according to screening mobility and cognitive&#xD;
      score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">November 15, 2018</completion_date>
  <primary_completion_date type="Actual">November 15, 2018</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Randomized Pilot Study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Late-Life Function and Disability Instrument at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Figure-of-8 Performance 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline 400 Meter Walk Test at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Range: 0-12; higher score better physical performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Cognitive Performance at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Trail Making Test at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Clock-in-the-Box Test at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Letter Fluency Test at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Hopkins Verbal Learning Test at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Mobility Limitation</condition>
  <arm_group>
    <arm_group_label>Functional Power + Cognitive Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Functional Power Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Training sessions began with 40 minutes of functional power training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>InVEST: Increased Velocity Exercise Specific to Task</intervention_name>
    <description>Functional Power Training</description>
    <arm_group_label>Functional Power + Cognitive Training</arm_group_label>
    <arm_group_label>Functional Power Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TAPAT: Tonic and Phasic Alertness Training</intervention_name>
    <description>Computerized cognitive training.</description>
    <arm_group_label>Functional Power + Cognitive Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65-90&#xD;
&#xD;
          -  History of fall in the past year OR difficulty or task modification with climbing one&#xD;
             flight of stairs or walking ½ mile (6 blocks)&#xD;
&#xD;
          -  Community Dwelling&#xD;
&#xD;
          -  Ability to speak and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a terminal disease (e.g. receiving hospice services, metastatic cancer&#xD;
&#xD;
          -  Major medical problem interfering with safe and successful testing (i.e. history of&#xD;
             hip replacement with recurrent dislocation; uncontrolled hypertension, use of&#xD;
             supplemental oxygen&#xD;
&#xD;
          -  Myocardial infarction or major surgery in previous 3 months&#xD;
&#xD;
          -  Planned major surgery (e.g. joint replacement)&#xD;
&#xD;
          -  Baseline Short Physical Performance Battery Score &lt;4 or &gt;10&#xD;
&#xD;
          -  Modified Mini Mental Status Examination score of ≤77 out of 100&#xD;
&#xD;
          -  Inability to safely complete the 400 meter walk test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>VA Boston Healthcare System</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Boston Healthcare System</investigator_affiliation>
    <investigator_full_name>Jonathan F. Bean</investigator_full_name>
    <investigator_title>Director, New England Geriatric Research Education and Clinical Center</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Aging</keyword>
  <keyword>Mobility Skills</keyword>
  <keyword>Cognitive Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mobility Limitation</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/NCT04446455
org study id: 3014
nct id: NCT04446455
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in
      Veterans 65 years and older. This study will also examine the neuromuscular and cognitive
      attributes that contribute to clinically meaningful improvements in mobility; and determine
      whether a novel mode of cognitive training can enhance cognition among mobility limited
      primary care Veterans 65 years and older.
This study is a randomized control pilot study. All participants will receive rehabilitative
      exercise addressing mobility skills. In addition, one group will be will receive additional
      cognitive training. Randomization is stratified according to screening mobility and cognitive
      score.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Pilot Study
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change from Baseline Late-Life Function and Disability Instrument at 6 weeks
time frame: Baseline, 6 weeks
description: Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument
measure: Change from Baseline Figure-of-8 Performance 6 weeks
time frame: Baseline, 6 weeks
measure: Change from Baseline 400 Meter Walk Test at 6 weeks
time frame: Baseline, 6 weeks
measure: Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks
time frame: Baseline, 6 weeks
description: Range: 0-12; higher score better physical performance
measure: Change from Baseline Cognitive Performance at 6 weeks
time frame: Baseline, 6 weeks
measure: Change from Baseline Trail Making Test at 6 weeks
time frame: Baseline, 6 weeks
measure: Change from Baseline Clock-in-the-Box Test at 6 weeks
time frame: Baseline, 6 weeks
measure: Change from Baseline Letter Fluency Test at 6 weeks
time frame: Baseline, 6 weeks
measure: Change from Baseline Hopkins Verbal Learning Test at 6 weeks
time frame: Baseline, 6 weeks
arm group label: Functional Power + Cognitive Training
arm group type: Experimental
description: Training sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training.
arm group label: Functional Power Training
arm group type: Active Comparator
description: Training sessions began with 40 minutes of functional power training.
intervention type: Other
intervention name: InVEST: Increased Velocity Exercise Specific to Task
description: Functional Power Training
arm group label: Functional Power + Cognitive Training
arm group label: Functional Power Training
intervention type: Other
intervention name: TAPAT: Tonic and Phasic Alertness Training
description: Computerized cognitive training.
arm group label: Functional Power + Cognitive Training
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA Boston Healthcare System
investigator full name: Jonathan F. Bean
investigator title: Director, New England Geriatric Research Education and Clinical Center
mesh term: Mobility Limitation
sharing ipd: No