<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/NCT02203656</url>
  </required_header>
  <id_info>
    <org_study_id>13-038</org_study_id>
    <secondary_id>1229</secondary_id>
    <nct_id>NCT02203656</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults</brief_title>
  <acronym>PACE</acronym>
  <official_title>Feasibility Study of Post-hospitalization Interventions to Improve Physical Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dairy Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Dairy Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the feasibility of interventions to accelerate recovery&#xD;
      of muscle mass and function in older adults following acute hospitalization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to test the feasibility of interventions to accelerate recovery&#xD;
      of muscle mass and function in older adults following acute hospitalization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score</measure>
    <time_frame>at pre-testing, 1-week post discharge and 4-week post discharge</time_frame>
    <description>Changes in SPPB score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>at pre-testing, 1-week post discharge and 4-week post discharge</time_frame>
    <description>Body composition will be measured using a bioimpedance scale. Changes in weight and % body fat will be calculated over the duration of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand grip strength (kg)</measure>
    <time_frame>at pre-testing, 1-week post discharge and 4-week post discharge</time_frame>
    <description>Changes in hand grip will be calculated over duration of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADLS, IADLS</measure>
    <time_frame>at pre-testing, 1-week post discharge and 4-week post discharge</time_frame>
    <description>Changes in Instrumental activities of daily living (IADLS), and Activities of daily living (ADLS) will be measured over the duration of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Levels</measure>
    <time_frame>at pre-testing, 1-week post discharge and 4-week post discharge</time_frame>
    <description>Physical activity levels will be measured using a step activity monitor and actiwatch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait Speed (m/s)</measure>
    <time_frame>at pre-testing, 1-week post discharge and 4-week post discharge</time_frame>
    <description>Changes in gait speed will be calculated over duration of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Measures</measure>
    <time_frame>at pre-testing, 1-week post discharge and 4-week post discharge</time_frame>
    <description>microRNA levels in blood will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 day re-hospitalization</measure>
    <time_frame>30 days post-discharge</time_frame>
    <description>re-hospitalization rates will be collected</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Follow-up Measures</measure>
    <time_frame>1 year post discharge</time_frame>
    <description>Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Placebo Supplement</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily placebo supplement for 30 days after discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutritional Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily nutritional supplement for 30 days after discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-home exercise + placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-home exercise + nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testosterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single testosterone injection within 24 hours of hospital discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo supplement</description>
    <arm_group_label>In-home exercise + placebo</arm_group_label>
    <arm_group_label>Placebo Supplement</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutritional Supplement</intervention_name>
    <description>protein supplement</description>
    <arm_group_label>In-home exercise + nutrition</arm_group_label>
    <arm_group_label>Nutritional Supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>In-home exercise</intervention_name>
    <description>In-home exercise program</description>
    <arm_group_label>In-home exercise + nutrition</arm_group_label>
    <arm_group_label>In-home exercise + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone</intervention_name>
    <description>Testosterone injection</description>
    <arm_group_label>Testosterone</arm_group_label>
    <other_name>Testosterone enanthate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to the University of Texas Medical Branch (UTMB) ACE unit with an admitting&#xD;
             diagnosis of congestive heart failure, respiratory infection, kidney/urinary tract&#xD;
             infection, or metabolic disorder; or other condition that will allow a subject to&#xD;
             participate in the study after patient review&#xD;
&#xD;
          -  Aged 65 years or older&#xD;
&#xD;
          -  Self-reported ability (with or without the aid of an assistive device) to walk across&#xD;
             a small room two weeks prior to hospitalization&#xD;
&#xD;
          -  Lives within 30 miles of UTMB&#xD;
&#xD;
          -  Can stand without assistance at the time of pretesting&#xD;
&#xD;
          -  Presents no medical contraindication to wearing a loose fitting velcro strap for the&#xD;
             accelerometer on one ankle&#xD;
&#xD;
          -  Score ≥26 on the 30-item Mini Mental State Examination or alert and oriented X3 by&#xD;
             physician on H&amp;P&#xD;
&#xD;
          -  Is discharged &quot;to home&quot; at ACE unit discharge.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nursing home resident or hospice patient&#xD;
&#xD;
          -  Uncontrolled blood pressure (systolic &gt;150, or diastolic &gt; 100)&#xD;
&#xD;
          -  History of stroke with motor disability&#xD;
&#xD;
          -  Glomerular filtration rate (GFR) &lt;30 mL/min/1.73m2 or evidence of kidney disease or&#xD;
             failure&#xD;
&#xD;
          -  Liver disease ( aspartate aminotransferase (AST) /Alanine transaminase (ALT) 2 times&#xD;
             above the normal limit, hyperbilirubinemia)&#xD;
&#xD;
          -  Recent (within 3 months) treatment with anabolic steroids&#xD;
&#xD;
          -  Any other condition or event considered exclusionary by the PI and faculty physician&#xD;
&#xD;
          -  Planned or elective hospitalization within 30 days of discharge&#xD;
&#xD;
        Additional Exclusion Criteria for Subjects Randomized to the Testosterone Group&#xD;
&#xD;
          -  Breast or prostate cancer&#xD;
&#xD;
          -  Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml&#xD;
&#xD;
          -  PSA ≥ 3 ng/ml in men at high risk of prostate cancer, such as African Americans or men&#xD;
             with first-degree relatives with prostate cancer&#xD;
&#xD;
          -  Hematocrit ≥ 50%&#xD;
&#xD;
          -  Decompensated heart failure as determined by a physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Volpi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTMB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UTMB Acute Care for Elders Unit</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jennie Sealy Hospital</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Deer RR, Dickinson JM, Fisher SR, Ju H, Volpi E. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial. Contemp Clin Trials. 2016 Jul;49:6-14. doi: 10.1016/j.cct.2016.05.001. Epub 2016 May 10.</citation>
    <PMID>27178766</PMID>
  </reference>
  <results_reference>
    <citation>Deer RR, Goodlett SM, Fisher SR, Baillargeon J, Dickinson JM, Raji M, Volpi E. A Randomized Controlled Pilot Trial of Interventions to Improve Functional Recovery After Hospitalization in Older Adults: Feasibility and Adherence. J Gerontol A Biol Sci Med Sci. 2018 Jan 16;73(2):187-193. doi: 10.1093/gerona/glx111.</citation>
    <PMID>28591764</PMID>
  </results_reference>
  <results_reference>
    <citation>Deer RR, Dickinson JM, Baillargeon J, Fisher SR, Raji M, Volpi E. A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1628-1636. doi: 10.1093/gerona/glz084.</citation>
    <PMID>30906944</PMID>
  </results_reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>May 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intervention studies</keyword>
  <keyword>nutrition</keyword>
  <keyword>exercise</keyword>
  <keyword>testosterone</keyword>
  <keyword>patient readmission</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No. This is a small Phase 1 pre-pilot study. Risk of loss of confidentiality</ipd_description>
  </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/NCT02203656
org study id: 13-038
secondary id: 1229
nct id: NCT02203656
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to test the feasibility of interventions to accelerate recovery
      of muscle mass and function in older adults following acute hospitalization.
The purpose of this study is to test the feasibility of interventions to accelerate recovery
      of muscle mass and function in older adults following acute hospitalization
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score
time frame: at pre-testing, 1-week post discharge and 4-week post discharge
description: Changes in SPPB score
measure: Body Composition
time frame: at pre-testing, 1-week post discharge and 4-week post discharge
description: Body composition will be measured using a bioimpedance scale. Changes in weight and % body fat will be calculated over the duration of the intervention.
measure: Hand grip strength (kg)
time frame: at pre-testing, 1-week post discharge and 4-week post discharge
description: Changes in hand grip will be calculated over duration of study.
measure: ADLS, IADLS
time frame: at pre-testing, 1-week post discharge and 4-week post discharge
description: Changes in Instrumental activities of daily living (IADLS), and Activities of daily living (ADLS) will be measured over the duration of the intervention.
measure: Physical Activity Levels
time frame: at pre-testing, 1-week post discharge and 4-week post discharge
description: Physical activity levels will be measured using a step activity monitor and actiwatch
measure: Gait Speed (m/s)
time frame: at pre-testing, 1-week post discharge and 4-week post discharge
description: Changes in gait speed will be calculated over duration of study.
measure: Blood Measures
time frame: at pre-testing, 1-week post discharge and 4-week post discharge
description: microRNA levels in blood will be measured
measure: 30 day re-hospitalization
time frame: 30 days post-discharge
description: re-hospitalization rates will be collected
measure: Follow-up Measures
time frame: 1 year post discharge
description: Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death
arm group label: Placebo Supplement
arm group type: Placebo Comparator
description: Daily placebo supplement for 30 days after discharge.
arm group label: Nutritional Supplement
arm group type: Experimental
description: Daily nutritional supplement for 30 days after discharge.
arm group label: In-home exercise + placebo
arm group type: Experimental
description: in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.
arm group label: In-home exercise + nutrition
arm group type: Experimental
description: in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.
arm group label: Testosterone
arm group type: Experimental
description: Single testosterone injection within 24 hours of hospital discharge.
intervention type: Drug
intervention name: Placebo
description: placebo supplement
arm group label: In-home exercise + placebo
arm group label: Placebo Supplement
other name: Control
intervention type: Dietary Supplement
intervention name: Nutritional Supplement
description: protein supplement
arm group label: In-home exercise + nutrition
arm group label: Nutritional Supplement
intervention type: Behavioral
intervention name: In-home exercise
description: In-home exercise program
arm group label: In-home exercise + nutrition
arm group label: In-home exercise + placebo
intervention type: Drug
intervention name: Testosterone
description: Testosterone injection
arm group label: Testosterone
other name: Testosterone enanthate
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Volpi, MD, PhD
role: Principal Investigator
affiliation: UTMB
facility: 
facility: 
country: United States
citation: Deer RR, Dickinson JM, Fisher SR, Ju H, Volpi E. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial. Contemp Clin Trials. 2016 Jul;49:6-14. doi: 10.1016/j.cct.2016.05.001. Epub 2016 May 10.
PMID: 27178766
citation: Deer RR, Goodlett SM, Fisher SR, Baillargeon J, Dickinson JM, Raji M, Volpi E. A Randomized Controlled Pilot Trial of Interventions to Improve Functional Recovery After Hospitalization in Older Adults: Feasibility and Adherence. J Gerontol A Biol Sci Med Sci. 2018 Jan 16;73(2):187-193. doi: 10.1093/gerona/glx111.
PMID: 28591764
citation: Deer RR, Dickinson JM, Baillargeon J, Fisher SR, Raji M, Volpi E. A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1628-1636. doi: 10.1093/gerona/glz084.
PMID: 30906944
responsible party type: Sponsor
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: No
ipd description: No. This is a small Phase 1 pre-pilot study. Risk of loss of confidentiality