<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/NCT02992275</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00072630</org_study_id>
    <nct_id>NCT02992275</nct_id>
  </id_info>
  <brief_title>NMES to Improve Hip Abductor Strength and Balance</brief_title>
  <acronym>IMAGINE+NMES</acronym>
  <official_title>Neuromuscular Electrical Stimulation as an Adjunct to Improve Hip Abductor Muscle Quality and Reduce Fall Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baltimore VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baltimore VA Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study will examine the addition of neuromuscular electrical stimulation (NMES) on the&#xD;
      hip abductors during strength training and a fall prevention program for improving muscle&#xD;
      strength and improving balance. All individuals in this study will receive NMES to their hip&#xD;
      abductors and will participate in a fall reduction program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Falls are a leading cause of disability in older adults. Decreased lower extremity muscle&#xD;
      mass and strength contribute to balance and mobility limitations. Our more recent work also&#xD;
      suggests that in addition to the traditional targets of muscle mass of the thigh and leg&#xD;
      muscles, dysfunction of the hip abductors may contribute to balance and mobility limitations&#xD;
      resulting in increased fall risk. Older adults with impaired hip abductor muscles demonstrate&#xD;
      increased amounts of intramuscular fat (IMAT) in and around the muscles, decreased hip&#xD;
      abductor strength, lower balance scores, increased gait variability (a predictor of future&#xD;
      falls), and poor stepping mechanics when recovering from a balance perturbation. Increased&#xD;
      IMAT and muscle dysfunction of the hip abductors may contribute to poor hip abductor muscle&#xD;
      recruitment and make changing these muscle during a traditional intervention difficult.&#xD;
      Neuromuscular electrical stimulation (NMES) is one method to improve muscle mass, strength&#xD;
      and quality in older adults, but has not traditionally been used on the hip abductors. We&#xD;
      propose that a targeted multimodality balance intervention (MMBI) focused on the lateral and&#xD;
      diagonal stepping and hip abductor strengthening when combined with NMES will result in&#xD;
      improvements in mobility and balance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mobility</measure>
    <time_frame>6 months</time_frame>
    <description>Mobility will be measured with the use of the mini-BesTest</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>6-months</time_frame>
    <description>Balance will be measured with the four-square step test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>6-months</time_frame>
    <description>Muscle strength will be measured as hip abductor strength quantified by use of a biodex</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Postural Balance</condition>
  <arm_group>
    <arm_group_label>NMES + MMBI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neuromuscular electrical stimulation (NMES)</intervention_name>
    <description>Participants will receive NMES to the hip abductors while performing strength training 3 times per week for 24 weeks</description>
    <arm_group_label>NMES + MMBI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multi-Modality Balance Intervention (MMBI)</intervention_name>
    <description>Participants will attend a group balance class that focuses on movement and obstacle negotiation 3 times per week for 24 weeks</description>
    <arm_group_label>NMES + MMBI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Mobility and balance limitations as demonstrated by a self-reported fall within the past&#xD;
        year or requiring greater than 8 seconds to complete the 4-square step test&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cardiovascular Risks: Poorly controlled hypertension (&gt;160/100); or patient report of:&#xD;
             symptomatic angina at rest or during exercise, syncope without known resolution of&#xD;
             cause, or a significant coronary event (such as a MI) in the past six months&#xD;
&#xD;
          2. COPD requiring home oxygen&#xD;
&#xD;
          3. Contraindications to resistance training, including a self-reported history of&#xD;
             intracranial or retinal bleeding in the last year or Diabetes with active&#xD;
             proliferative retinopathy&#xD;
&#xD;
          4. Patient report of significant spinal stenosis that would limit participation in the&#xD;
             exercise intervention&#xD;
&#xD;
          5. Non-ambulatory mobility status or a transtibial or transfemoral amputation&#xD;
&#xD;
          6. Dementia (on medical record review or mini-mental status exam score &lt;24).&#xD;
&#xD;
          7. Other severe medical illness or condition that would preclude safe participation in&#xD;
             the study as determined by the study team&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Les Katzel, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Director Baltmore GRECC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Odessa Addison, DPT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Scientist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baltimore VA Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baltimore VA Medical Center</investigator_affiliation>
    <investigator_full_name>Odessa Addison</investigator_full_name>
    <investigator_title>Research Scientist</investigator_title>
  </responsible_party>
  <keyword>Hip</keyword>
  <keyword>Muscle</keyword>
  <keyword>Skeletal/physiopathology</keyword>
  <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/NCT02992275
org study id: HP-00072630
nct id: NCT02992275
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will examine the addition of neuromuscular electrical stimulation (NMES) on the
      hip abductors during strength training and a fall prevention program for improving muscle
      strength and improving balance. All individuals in this study will receive NMES to their hip
      abductors and will participate in a fall reduction program.
Falls are a leading cause of disability in older adults. Decreased lower extremity muscle
      mass and strength contribute to balance and mobility limitations. Our more recent work also
      suggests that in addition to the traditional targets of muscle mass of the thigh and leg
      muscles, dysfunction of the hip abductors may contribute to balance and mobility limitations
      resulting in increased fall risk. Older adults with impaired hip abductor muscles demonstrate
      increased amounts of intramuscular fat (IMAT) in and around the muscles, decreased hip
      abductor strength, lower balance scores, increased gait variability (a predictor of future
      falls), and poor stepping mechanics when recovering from a balance perturbation. Increased
      IMAT and muscle dysfunction of the hip abductors may contribute to poor hip abductor muscle
      recruitment and make changing these muscle during a traditional intervention difficult.
      Neuromuscular electrical stimulation (NMES) is one method to improve muscle mass, strength
      and quality in older adults, but has not traditionally been used on the hip abductors. We
      propose that a targeted multimodality balance intervention (MMBI) focused on the lateral and
      diagonal stepping and hip abductor strengthening when combined with NMES will result in
      improvements in mobility and balance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mobility
time frame: 6 months
description: Mobility will be measured with the use of the mini-BesTest
measure: Balance
time frame: 6-months
description: Balance will be measured with the four-square step test
measure: Muscle Strength
time frame: 6-months
description: Muscle strength will be measured as hip abductor strength quantified by use of a biodex
arm group label: NMES + MMBI
arm group type: Experimental
description: Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention
intervention type: Other
intervention name: Neuromuscular electrical stimulation (NMES)
description: Participants will receive NMES to the hip abductors while performing strength training 3 times per week for 24 weeks
arm group label: NMES + MMBI
intervention type: Other
intervention name: Multi-Modality Balance Intervention (MMBI)
description: Participants will attend a group balance class that focuses on movement and obstacle negotiation 3 times per week for 24 weeks
arm group label: NMES + MMBI
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Les Katzel, MD, PhD
role: Study Director
affiliation: Director Baltmore GRECC
last name: Odessa Addison, DPT, PhD
role: Principal Investigator
affiliation: Research Scientist
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baltimore VA Medical Center
investigator full name: Odessa Addison
investigator title: Research Scientist
sharing ipd: No