<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/NCT03826771</url>
  </required_header>
  <id_info>
    <org_study_id>00077223</org_study_id>
    <secondary_id>R01HD095137</secondary_id>
    <nct_id>NCT03826771</nct_id>
  </id_info>
  <brief_title>Post-Stroke Optimization of Walking Using Explosive Resistance</brief_title>
  <acronym>POWER-D</acronym>
  <official_title>Post-Stroke Optimization of Walking Using Explosive Resistance: Concurrent Effects on Depression (POWER-D Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will study the effects of a 12 week strength training program on&#xD;
      individuals who have had a stroke and are depressed to see if this type of exercise training&#xD;
      helps treat depression and improves walking function. Our goal is to use the information&#xD;
      collected in this study to help design treatments for people who have had a stroke that will&#xD;
      help with many of the common consequences of stroke, including depression, muscle weakness&#xD;
      and slow walking. Progress toward overcoming some of these issues would be incredibly&#xD;
      valuable to any person who has had a stroke and their families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is the most common neuropsychiatric manifestation following stroke and current&#xD;
      treatments are largely ineffective. Depression has both direct and indirect effects on&#xD;
      response to rehabilitation, thus subjects with post-stroke depression (PSD) are routinely&#xD;
      excluded from clinical trials and treatment options are extremely limited. The investigators&#xD;
      propose to determine the impact of a novel, high-intensity resistance training program,&#xD;
      Post-stroke Optimization of Walking using Explosive Resistance (POWER) training, on&#xD;
      post-stroke depressive symptoms. Further, the investiators will determine if depression&#xD;
      limits training-induced improvements in muscular and locomotor function. This project is&#xD;
      based on the premise that depression negatively affects the potential for neuroplastic&#xD;
      changes to occur in response to treatment such that rehabilitation may not produce the same&#xD;
      adaptations that it does in non-depressed individuals. The investigators propose that&#xD;
      effective treatment for PSD would result in a virtuous cycle where reducing depression&#xD;
      enhances neuroplastic changes, thereby facilitating functional gains. That is, effectively&#xD;
      treating depression will make the individual better able to recover from stroke. Furthermore,&#xD;
      in addition to its beneficial effects on depression, POWER training is known to improve&#xD;
      post-stroke walking, thus providing an attractive option for treating depression as well as&#xD;
      an established vehicle to study the effects of PSD on response to rehabilitation. The&#xD;
      experiments proposed as part of this project are designed to address critical questions&#xD;
      related to 1) the effects of POWER training on depressive symptoms; 2) the potential for PSD&#xD;
      to limit improvements following training; and 3) the interaction between improvements in&#xD;
      depression and increases in walking function. Successful completion of this project will&#xD;
      provide a foundation for larger scale trials to determine dosing parameters as well as&#xD;
      establish therapeutic effectiveness of POWER training on post-stroke depression as well as&#xD;
      identify the mechanisms that may be responsible for the changes that occur in response to&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression</measure>
    <time_frame>Visit 1 through visit 24 (up to 12 weeks)</time_frame>
    <description>The Hamilton Rating Scale for Depression, abbreviated HAM-D, is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. A score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Self Selected Walking Speed</measure>
    <time_frame>Visit 1 through visit 24 (up to 12 weeks)</time_frame>
    <description>Subjects will walk on a 14-ft. long gait mat (GaitRite) to measure self-selected and fastest comfortable walking speed and other spatiotemporal parameters of walking. Subjects will be permitted a practice trial, and then be asked to complete three trials at each speed. For all trials, subjects will wear their own shoes and be asked to walk without an assistive device or ankle-foot orthosis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Stroke</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>POWER training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>high velocity strength training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stretching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Upper and lower body range of motion exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Power training</intervention_name>
    <description>high-intensity lower extremity resistance training</description>
    <arm_group_label>POWER training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stretching</intervention_name>
    <description>upper and lower body range of motion exercises</description>
    <arm_group_label>Stretching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 50-70&#xD;
&#xD;
          -  stroke within the past 6 to 60 months&#xD;
&#xD;
          -  residual paresis in the lower extremity (Fugl-Meyer LE motor score &lt;34)&#xD;
&#xD;
          -  ability to walk without assistance and without an AFO during testing and training at&#xD;
             speeds ranging from 0.2-0.8 m/s&#xD;
&#xD;
          -  no antidepressant medications or no change in doses of psychotropic medication for at&#xD;
             least 4 weeks prior to the study (6 weeks if newly initiated medication)&#xD;
&#xD;
          -  HRSD question #9 regarding suicide &lt;2; and 7) provision of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent&#xD;
             claudication while walking&#xD;
&#xD;
          -  history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic&#xD;
             cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's&#xD;
&#xD;
          -  History of COPD or oxygen dependence&#xD;
&#xD;
          -  Preexisting neurological disorders, dementia or previous stroke&#xD;
&#xD;
          -  History of major head trauma&#xD;
&#xD;
          -  Legal blindness or severe visual impairment&#xD;
&#xD;
          -  history of psychosis or other Axis I disorder that is primary&#xD;
&#xD;
          -  Life expectancy &lt;1 yr.&#xD;
&#xD;
          -  Severe arthritis or other problems that limit passive ROM&#xD;
&#xD;
          -  History of DVT or pulmonary embolism within 6 months&#xD;
&#xD;
          -  Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin&#xD;
             reactions&#xD;
&#xD;
          -  Severe hypertension with systolic &gt;200 mmHg and diastolic &gt;110 mmHg at rest&#xD;
&#xD;
          -  attempt of suicide in the last 2 years or at suicidal risk assessed by SCID interview&#xD;
&#xD;
          -  History of seizures or currently prescribed anti-seizure medications&#xD;
&#xD;
          -  Current enrollment in a clinical trial to enhance motor recovery&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chris M Gregory, PhD</last_name>
    <phone>8437921078</phone>
    <email>gregoryc@musc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Chris Gregory</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>depression</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT03826771
org study id: 00077223
secondary id: R01HD095137
nct id: NCT03826771
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The investigators will study the effects of a 12 week strength training program on
      individuals who have had a stroke and are depressed to see if this type of exercise training
      helps treat depression and improves walking function. Our goal is to use the information
      collected in this study to help design treatments for people who have had a stroke that will
      help with many of the common consequences of stroke, including depression, muscle weakness
      and slow walking. Progress toward overcoming some of these issues would be incredibly
      valuable to any person who has had a stroke and their families.
Depression is the most common neuropsychiatric manifestation following stroke and current
      treatments are largely ineffective. Depression has both direct and indirect effects on
      response to rehabilitation, thus subjects with post-stroke depression (PSD) are routinely
      excluded from clinical trials and treatment options are extremely limited. The investigators
      propose to determine the impact of a novel, high-intensity resistance training program,
      Post-stroke Optimization of Walking using Explosive Resistance (POWER) training, on
      post-stroke depressive symptoms. Further, the investiators will determine if depression
      limits training-induced improvements in muscular and locomotor function. This project is
      based on the premise that depression negatively affects the potential for neuroplastic
      changes to occur in response to treatment such that rehabilitation may not produce the same
      adaptations that it does in non-depressed individuals. The investigators propose that
      effective treatment for PSD would result in a virtuous cycle where reducing depression
      enhances neuroplastic changes, thereby facilitating functional gains. That is, effectively
      treating depression will make the individual better able to recover from stroke. Furthermore,
      in addition to its beneficial effects on depression, POWER training is known to improve
      post-stroke walking, thus providing an attractive option for treating depression as well as
      an established vehicle to study the effects of PSD on response to rehabilitation. The
      experiments proposed as part of this project are designed to address critical questions
      related to 1) the effects of POWER training on depressive symptoms; 2) the potential for PSD
      to limit improvements following training; and 3) the interaction between improvements in
      depression and increases in walking function. Successful completion of this project will
      provide a foundation for larger scale trials to determine dosing parameters as well as
      establish therapeutic effectiveness of POWER training on post-stroke depression as well as
      identify the mechanisms that may be responsible for the changes that occur in response to
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression
time frame: Visit 1 through visit 24 (up to 12 weeks)
description: The Hamilton Rating Scale for Depression, abbreviated HAM-D, is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. A score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
measure: Change in Self Selected Walking Speed
time frame: Visit 1 through visit 24 (up to 12 weeks)
description: Subjects will walk on a 14-ft. long gait mat (GaitRite) to measure self-selected and fastest comfortable walking speed and other spatiotemporal parameters of walking. Subjects will be permitted a practice trial, and then be asked to complete three trials at each speed. For all trials, subjects will wear their own shoes and be asked to walk without an assistive device or ankle-foot orthosis.
arm group label: POWER training
arm group type: Experimental
description: high velocity strength training
arm group label: Stretching
arm group type: Active Comparator
description: Upper and lower body range of motion exercises
intervention type: Behavioral
intervention name: Power training
description: high-intensity lower extremity resistance training
arm group label: POWER training
intervention type: Behavioral
intervention name: Stretching
description: upper and lower body range of motion exercises
arm group label: Stretching
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
last name: Chris M Gregory, PhD
phone: 8437921078
email: gregoryc@musc.edu
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Chris Gregory
investigator title: PhD
mesh term: Stroke
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Undecided