<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/NCT03247205</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00073627</org_study_id>
    <nct_id>NCT03247205</nct_id>
  </id_info>
  <brief_title>Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study</brief_title>
  <acronym>HipERS</acronym>
  <official_title>Feasibility of Extended Post-Acute Intervention for Hip Fracture Patients With Cognitive Limitations: Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study (HipERS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</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 pilot study will look at whether it is possible to give better physical therapy to&#xD;
      people with cognitive limitations who have had a hip fracture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although a small number of interventions have been found to be effective in improving&#xD;
      mobility and functional recovery after a hip fracture, these studies have routinely excluded&#xD;
      patients with cognitive limitations, a group with poor outcomes after hip fracture. It is&#xD;
      estimated that 15-20% of all hip fracture patients experience cognitive limitation following&#xD;
      surgery from previously undetected cognitive impairment, delirium, and other post-operative&#xD;
      complications that persist following hospital discharge and those with cognitive limitations&#xD;
      are slow to recover. Despite potential for a full recovery, many hip fracture patients with&#xD;
      cognitive limitation may be discharged early from rehabilitation settings due to&#xD;
      misperceptions about rehabilitation potential, or other psychological issues that limit their&#xD;
      participation.&#xD;
&#xD;
      The innovation of this study is that it focuses on a critically vulnerable and costly group&#xD;
      of patients (hip fracture patients with cognitive limitations) with an extended intervention&#xD;
      that is tailored to the patient's needs and cognitive abilities. The post-rehabilitation&#xD;
      period after hip fracture has been largely ignored and little is known about the effective&#xD;
      strategies to help transition and maintain hip fracture patients (especially those with&#xD;
      cognitive limitations) in the home setting. HipERS utilizes an effective approach to address&#xD;
      for functional gains, but where limited attention has been given. It focuses on motivational&#xD;
      and behavioral challenges in patients with cognitive limitations and their caregivers, which&#xD;
      has been largely ignored in the hip fracture research&#xD;
&#xD;
      This study will gather information from 5 people with cognitive limitations who fractured a&#xD;
      hip. Caregivers (family relative or non-relative, unpaid or paid, formal or informal) will&#xD;
      also be invited to participate. Hip fracture participants will receive a home-based exercise&#xD;
      intervention that will start after their &quot;normal&quot; rehabilitation is done. The function-based&#xD;
      exercise intervention will be provided by physical therapists 2-3 times a week for 6 weeks.&#xD;
      Additionally, the physical therapist will encourage the caregiver to motivate and actively&#xD;
      engage the hip fracture participant in the therapist-prescribed home exercise program so that&#xD;
      this can be maintained at the end of the 6-week intervention. The feasibility of the&#xD;
      intervention will be based on the percentage of sessions participants complete. The&#xD;
      information we get from this feasibility study will be used to plan a larger study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding ran out and no subjects recruited.&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2018</start_date>
  <completion_date type="Actual">August 22, 2018</completion_date>
  <primary_completion_date type="Actual">August 22, 2018</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>
    <intervention_model_description>All participants will receive the intervention</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of the Intervention</measure>
    <time_frame>6 weeks</time_frame>
    <description>Data regarding feasibility will include numbers of participants contacted, enrolled, drop-outs/withdrawals, and completing intervention and the number of adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the Intervention (time)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Data regarding feasibility will include total time to implement the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Fidelity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Treatment fidelity of the intervention will include recording of adherence and logs of intervention tasks and problems regarding barriers to implementation of the intervention and open-ended interviews with caregivers about their experiences with the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery (SPPB)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Short Physical Performance Battery (SPPB) will be used to assess timed physical performance of balance, gait, strength, and endurance. Walking speed over 3 meters and a single timed chair rise without using arms will also be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Index for Activities of Daily Living</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Barthel Index will be rated by research staff after observing activity of daily living (ADL) performance. The Barthel Index is a measure of physical function that assesses a participant's ability for self-care. The Barthel Index consists of 14 items, each of which relates to a different functional activity. A total score of 100 indicates complete independence in self-care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower Extremity Gain Scale (LEGS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Lower Extremity Gain Scale (LEGS) is a portable measure of gait and global balance, specially developed for older adults who have sustained a hip fracture. This performance measure determines how steady or unsteady the older adult is during a series of balance and gait tasks. The tasks are summarized to yield an 11-item balance score, an 8-item gait score, and a combined overall mobility score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric Inventory (NPI)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Behavioral and affective outcomes will be used to examine the impact of the intervention on behavioral symptoms of cognitive limitation using the Neuropsychiatric Inventory (NPI). The NPI includes items on 10 behavioral disturbances: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. These are all rated by the caregiver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Interview</measure>
    <time_frame>6 weeks</time_frame>
    <description>Caregiver burden will be assessed using the Zarit Burden Interview, a 22-item scale answered by caregivers, response options ranging from 0 (Never) to 4 (Nearly Always). Factors capture personal strain and role strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instrumental Activities of Daily Living (IADLs)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Instrumental activities of daily living (IADLs) will be measured by 7 items from the Older Americans' Resources and Services (OARS) Activities of Daily Living Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>6 weeks</time_frame>
    <description>Falls and other adverse events, including hospitalization, nursing home placement, and death, will be recorded throughout the study.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>HipERS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A trained physical therapist will visit each participant for a 1-hour session 3 times a week for the initial 2 weeks, and then 2 times a week for 4 weeks (total 14 hours over 6 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HipERS</intervention_name>
    <description>This is a graduated, functionally-based exercise intervention conducted in the participant's home. The intervention incorporates verbal encouragement and positive reinforcement, role modeling, assessment of and elimination of unpleasant sensations associated with an activity, and confidence building through activity repetition. The exercise component includes 1) strengthening exercises, 2) range of motion exercises, 3) balance training, 4) functional training, such as chair rising, ambulation training, and stair climbing, 5) transfer practice, 6) adjusting walking aides, and 7) adapting and modifying environment; with a focus on lower extremity tasks in all these areas.</description>
    <arm_group_label>HipERS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Hip Fracture Participant&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Hip fracture&#xD;
&#xD;
          -  Age 65+ at time of fracture&#xD;
&#xD;
          -  Had surgical repair for the hip fracture&#xD;
&#xD;
          -  Completed usual rehabilitation&#xD;
&#xD;
          -  Discharged to the community after rehabilitation ends (i.e., private home or assisted&#xD;
             living)&#xD;
&#xD;
          -  Cognitive limitation (MoCA score 18-25)&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Pathologic fracture&#xD;
&#xD;
          -  Not community-dwelling (e.g., nursing home resident) prior to fracture&#xD;
&#xD;
          -  Bedbound during the 6 months prior to fracture&#xD;
&#xD;
          -  Not returning to the community before 180 days post-hospital discharge (can go to&#xD;
             assisted living)&#xD;
&#xD;
          -  Not authorized by a physician to participate in an exercise or rehabilitation program&#xD;
             prior to starting the intervention&#xD;
&#xD;
          -  Gait speed of greater than 0.8 m/s (already walking well) at baseline&#xD;
&#xD;
        Caregiver Participant&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Identified as a caregiver (i.e., family relative or non-relative, unpaid or paid,&#xD;
             informal or formal) who will help or supervise the hip fracture participant with ADL&#xD;
             or IADL tasks after discharge from rehab&#xD;
&#xD;
          -  Helping or supervising the hip fracture participant with one or more ADL or IADL tasks&#xD;
             at least weekly when screened for this study OR plans to be the primary person&#xD;
             providing care at least weekly after the hip fracture participant is discharged from&#xD;
             rehab&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Not English speaking&#xD;
&#xD;
          -  Living more than 40 miles from the hip fracture participant&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann Gruber-Baldini, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, Baltimore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Maryland</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 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>February 22, 2022</last_update_submitted>
  <last_update_submitted_qc>February 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Ann Gruber-Baldini</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>hip fracture</keyword>
  <keyword>cognitive impairment</keyword>
  <keyword>physical therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT03247205
org study id: HP-00073627
nct id: NCT03247205
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot study will look at whether it is possible to give better physical therapy to
      people with cognitive limitations who have had a hip fracture.
Although a small number of interventions have been found to be effective in improving
      mobility and functional recovery after a hip fracture, these studies have routinely excluded
      patients with cognitive limitations, a group with poor outcomes after hip fracture. It is
      estimated that 15-20% of all hip fracture patients experience cognitive limitation following
      surgery from previously undetected cognitive impairment, delirium, and other post-operative
      complications that persist following hospital discharge and those with cognitive limitations
      are slow to recover. Despite potential for a full recovery, many hip fracture patients with
      cognitive limitation may be discharged early from rehabilitation settings due to
      misperceptions about rehabilitation potential, or other psychological issues that limit their
      participation.

      The innovation of this study is that it focuses on a critically vulnerable and costly group
      of patients (hip fracture patients with cognitive limitations) with an extended intervention
      that is tailored to the patient's needs and cognitive abilities. The post-rehabilitation
      period after hip fracture has been largely ignored and little is known about the effective
      strategies to help transition and maintain hip fracture patients (especially those with
      cognitive limitations) in the home setting. HipERS utilizes an effective approach to address
      for functional gains, but where limited attention has been given. It focuses on motivational
      and behavioral challenges in patients with cognitive limitations and their caregivers, which
      has been largely ignored in the hip fracture research

      This study will gather information from 5 people with cognitive limitations who fractured a
      hip. Caregivers (family relative or non-relative, unpaid or paid, formal or informal) will
      also be invited to participate. Hip fracture participants will receive a home-based exercise
      intervention that will start after their "normal" rehabilitation is done. The function-based
      exercise intervention will be provided by physical therapists 2-3 times a week for 6 weeks.
      Additionally, the physical therapist will encourage the caregiver to motivate and actively
      engage the hip fracture participant in the therapist-prescribed home exercise program so that
      this can be maintained at the end of the 6-week intervention. The feasibility of the
      intervention will be based on the percentage of sessions participants complete. The
      information we get from this feasibility study will be used to plan a larger study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants will receive the intervention
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of the Intervention
time frame: 6 weeks
description: Data regarding feasibility will include numbers of participants contacted, enrolled, drop-outs/withdrawals, and completing intervention and the number of adverse events.
measure: Feasibility of the Intervention (time)
time frame: 6 weeks
description: Data regarding feasibility will include total time to implement the intervention.
measure: Treatment Fidelity
time frame: 6 weeks
description: Treatment fidelity of the intervention will include recording of adherence and logs of intervention tasks and problems regarding barriers to implementation of the intervention and open-ended interviews with caregivers about their experiences with the intervention.
measure: Short Physical Performance Battery (SPPB)
time frame: 6 weeks
description: Short Physical Performance Battery (SPPB) will be used to assess timed physical performance of balance, gait, strength, and endurance. Walking speed over 3 meters and a single timed chair rise without using arms will also be assessed.
measure: Barthel Index for Activities of Daily Living
time frame: 6 weeks
description: The Barthel Index will be rated by research staff after observing activity of daily living (ADL) performance. The Barthel Index is a measure of physical function that assesses a participant's ability for self-care. The Barthel Index consists of 14 items, each of which relates to a different functional activity. A total score of 100 indicates complete independence in self-care.
measure: Lower Extremity Gain Scale (LEGS)
time frame: 6 weeks
description: The Lower Extremity Gain Scale (LEGS) is a portable measure of gait and global balance, specially developed for older adults who have sustained a hip fracture. This performance measure determines how steady or unsteady the older adult is during a series of balance and gait tasks. The tasks are summarized to yield an 11-item balance score, an 8-item gait score, and a combined overall mobility score
measure: Neuropsychiatric Inventory (NPI)
time frame: 6 weeks
description: Behavioral and affective outcomes will be used to examine the impact of the intervention on behavioral symptoms of cognitive limitation using the Neuropsychiatric Inventory (NPI). The NPI includes items on 10 behavioral disturbances: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. These are all rated by the caregiver.
measure: Zarit Burden Interview
time frame: 6 weeks
description: Caregiver burden will be assessed using the Zarit Burden Interview, a 22-item scale answered by caregivers, response options ranging from 0 (Never) to 4 (Nearly Always). Factors capture personal strain and role strain.
measure: Instrumental Activities of Daily Living (IADLs)
time frame: 6 weeks
description: Instrumental activities of daily living (IADLs) will be measured by 7 items from the Older Americans' Resources and Services (OARS) Activities of Daily Living Questionnaire.
measure: Adverse Events
time frame: 6 weeks
description: Falls and other adverse events, including hospitalization, nursing home placement, and death, will be recorded throughout the study.
arm group label: HipERS
arm group type: Experimental
description: A trained physical therapist will visit each participant for a 1-hour session 3 times a week for the initial 2 weeks, and then 2 times a week for 4 weeks (total 14 hours over 6 weeks).
intervention type: Behavioral
intervention name: HipERS
description: This is a graduated, functionally-based exercise intervention conducted in the participant's home. The intervention incorporates verbal encouragement and positive reinforcement, role modeling, assessment of and elimination of unpleasant sensations associated with an activity, and confidence building through activity repetition. The exercise component includes 1) strengthening exercises, 2) range of motion exercises, 3) balance training, 4) functional training, such as chair rising, ambulation training, and stair climbing, 5) transfer practice, 6) adjusting walking aides, and 7) adapting and modifying environment; with a focus on lower extremity tasks in all these areas.
arm group label: HipERS
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ann Gruber-Baldini, PhD
role: Principal Investigator
affiliation: University of Maryland, Baltimore
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Ann Gruber-Baldini
investigator title: Professor
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Cognitive Dysfunction
sharing ipd: No