xml: <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/NCT05963113</url>
    </required_header>
    <id_info>
      <org_study_id>23-00293</org_study_id>
      <nct_id>NCT05963113</nct_id>
    </id_info>
    <brief_title>Pharyngeal Exercise (Plus Protein)</brief_title>
    <acronym>PE(PP)</acronym>
    <official_title>A Single-center Randomized Clinical Trial to Test the Efficacy of Pharyngeal Swallowing Exercises (With or Without Protein Supplementation) to Build Pharyngeal Muscular Reserve in Pre-frail Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>NYU Langone Health</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>
        The swallowing muscles are prone to decreased strength and function as part of the natural&#xD;
        aging process which can lead to difficulty swallowing, malnutrition, and frailty. Exercise&#xD;
        and nutrition are powerful stimulators of muscular change. The proposed research will&#xD;
        investigate the effectiveness of a 12-week proactive regimen of swallowing exercises (with or&#xD;
        without daily protein supplement drinks) to improve the composition, force, and physiology of&#xD;
        the swallowing muscles and explore the relationship to overall health and physical function&#xD;
        in 80 community-dwelling older adults. Each participant will serve as their own control for&#xD;
        12 weeks before being randomized to complete swallowing exercises alone or swallowing&#xD;
        exercises with protein drinks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2028</primary_completion_date>
    <phase>N/A</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>Prevention</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>The PI, outcome assessors, and individuals conducting data analyses will be blinded to randomization. The treating clinicians and participants will be aware of their study group given that they will be provided with either water or protein drinks.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Thickness of the Superior Pharyngeal Constrictor Muscle</measure>
      <time_frame>Baseline, Week 13</time_frame>
      <description>Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Thickness of the Superior Pharyngeal Constrictor Muscle</measure>
      <time_frame>Baseline, Week 28</time_frame>
      <description>Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Thickness of the Middle Pharyngeal Constrictor Muscle</measure>
      <time_frame>Baseline, Week 13</time_frame>
      <description>Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Thickness of the Middle Pharyngeal Constrictor Muscle</measure>
      <time_frame>Baseline, Week 28</time_frame>
      <description>Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Thickness of the Inferior Pharyngeal Constrictor Muscle</measure>
      <time_frame>Baseline, Week 13</time_frame>
      <description>Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Thickness of the Inferior Pharyngeal Constrictor Muscle</measure>
      <time_frame>Baseline, Week 28</time_frame>
      <description>Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Maximum Pharyngeal Constriction During Swallowing</measure>
      <time_frame>Baseline, Week 13</time_frame>
      <description>Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Maximum Pharyngeal Constriction During Swallowing</measure>
      <time_frame>Baseline, Week 28</time_frame>
      <description>Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Short Physical Performance Battery (SPPB) Scores</measure>
      <time_frame>Baseline, Week 13</time_frame>
      <description>The SPPB comprises a gait speed test, a chair stand test, and three balance tests. The gait speed test score ranges from 0 (worst outcome) to 4 (best outcome); the chair stand test score ranges from 0 (worst outcome) to 4 (best outcome); the side-by-side stand test score ranges from 1 (best outcome) to 0 (worst outcome); the semi-tandem stand test score ranges from 1 (best outcome) to 0 (worst outcome); and the tandem stand test scores range from 2 (best outcome) to 0 (worst outcome).&#xD;
  The total SPPB score is the sum of the test scores and ranges from 0-12, with lower scores indicating greater disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Short Physical Performance Battery (SPPB) Scores</measure>
      <time_frame>Baseline, Week 28</time_frame>
      <description>The SPPB comprises a gait speed test, a chair stand test, and three balance tests. The gait speed test score ranges from 0 (worst outcome) to 4 (best outcome); the chair stand test score ranges from 0 (worst outcome) to 4 (best outcome); the side-by-side stand test score ranges from 1 (best outcome) to 0 (worst outcome); the semi-tandem stand test score ranges from 1 (best outcome) to 0 (worst outcome); and the tandem stand test scores range from 2 (best outcome) to 0 (worst outcome).&#xD;
  The total SPPB score is the sum of the test scores and ranges from 0-12, with lower scores indicating greater disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Fat-Free Muscle Index</measure>
      <time_frame>Baseline, Week 13</time_frame>
      <description>Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Fat-Free Muscle Index</measure>
      <time_frame>Baseline, Week 28</time_frame>
      <description>Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pre-Albumin Levels</measure>
      <time_frame>Baseline, Week 13</time_frame>
      <description>Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pre-Albumin Levels</measure>
      <time_frame>Baseline, Week 28</time_frame>
      <description>Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Pre-Frail Older Adults</condition>
    <arm_group>
      <arm_group_label>Control, then Swallowing Exercises + Protein</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of &quot;usual activity.&quot;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control, then Swallowing Exercises</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of &quot;usual activity.&quot;</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pharyngeal Swallowing Exercises</intervention_name>
      <description>12-weeks of proactive pharyngeal swallowing exercises conducted 5 times per week. The exercise program will include the following four exercises: effortful saliva swallows, tongue-hold swallows, effortful pitch glides and posterior lingual resistance. Each exercise set will include 10 repetitions of each exercise (40 reps per set). The number of sets will be gradually increased as tolerance builds.</description>
      <arm_group_label>Control, then Swallowing Exercises</arm_group_label>
      <arm_group_label>Control, then Swallowing Exercises + Protein</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Protein Supplementation</intervention_name>
      <description>12-week supply of the commercially-available Premier Protein Clear ® High Protein (20 grams of protein and 90 calories per 16.9 oz. drink). Participants will be asked to consume one drink per day for the 12-week intervention period.</description>
      <arm_group_label>Control, then Swallowing Exercises + Protein</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MRI</intervention_name>
      <description>Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.</description>
      <arm_group_label>Control, then Swallowing Exercises</arm_group_label>
      <arm_group_label>Control, then Swallowing Exercises + Protein</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants must be 65 years of age or older.&#xD;
  &#xD;
            2. Participants must score a 1 or 2 on the FRAIL scale OR a 4 or greater on the Strength,&#xD;
               Assistance in Walking, Rise from a Chair, Climb Stairs and Falls (SARC-F)&#xD;
               Questionnaire.&#xD;
  &#xD;
            3. Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA).&#xD;
  &#xD;
            4. Willingness to participate in the study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known structural or neurological causes of dysphagia.&#xD;
  &#xD;
            2. Cannot consume high levels of protein (Chronic Kidney Disease Stage 3 or higher).&#xD;
  &#xD;
            3. Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm&#xD;
               clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye,&#xD;
               claustrophobia, or other problems).&#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>Sonja Molfenter</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sonja Molfenter</last_name>
      <phone>212-992-7694</phone>
      <email>Smm16@nyu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Matina Balou</last_name>
      <phone>646-754-1207</phone>
      <email>Stamatela.Balou@nyulangone.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NYU Steinhardt School of Education</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10003</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>NYU Langone Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10017</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>proactive exercise</keyword>
    <keyword>protein</keyword>
    <keyword>nutrition</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: smm16@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
      <ipd_access_criteria>The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to smm16@nyu.edu. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963113
  org study id: 23-00293
  nct id: NCT05963113
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The swallowing muscles are prone to decreased strength and function as part of the natural
        aging process which can lead to difficulty swallowing, malnutrition, and frailty. Exercise
        and nutrition are powerful stimulators of muscular change. The proposed research will
        investigate the effectiveness of a 12-week proactive regimen of swallowing exercises (with or
        without daily protein supplement drinks) to improve the composition, force, and physiology of
        the swallowing muscles and explore the relationship to overall health and physical function
        in 80 community-dwelling older adults. Each participant will serve as their own control for
        12 weeks before being randomized to complete swallowing exercises alone or swallowing
        exercises with protein drinks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Investigator, Outcomes Assessor)
  masking description: The PI, outcome assessors, and individuals conducting data analyses will be blinded to randomization. The treating clinicians and participants will be aware of their study group given that they will be provided with either water or protein drinks.
  measure: Change in Thickness of the Superior Pharyngeal Constrictor Muscle
  time frame: Baseline, Week 13
  description: Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle.
  measure: Change in Thickness of the Superior Pharyngeal Constrictor Muscle
  time frame: Baseline, Week 28
  description: Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle.
  measure: Change in Thickness of the Middle Pharyngeal Constrictor Muscle
  time frame: Baseline, Week 13
  description: Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle.
  measure: Change in Thickness of the Middle Pharyngeal Constrictor Muscle
  time frame: Baseline, Week 28
  description: Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle.
  measure: Change in Thickness of the Inferior Pharyngeal Constrictor Muscle
  time frame: Baseline, Week 13
  description: Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle.
  measure: Change in Thickness of the Inferior Pharyngeal Constrictor Muscle
  time frame: Baseline, Week 28
  description: Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle.
  measure: Change in Maximum Pharyngeal Constriction During Swallowing
  time frame: Baseline, Week 13
  description: Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.
  measure: Change in Maximum Pharyngeal Constriction During Swallowing
  time frame: Baseline, Week 28
  description: Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.
  measure: Change in Short Physical Performance Battery (SPPB) Scores
  time frame: Baseline, Week 13
  description: The SPPB comprises a gait speed test, a chair stand test, and three balance tests. The gait speed test score ranges from 0 (worst outcome) to 4 (best outcome); the chair stand test score ranges from 0 (worst outcome) to 4 (best outcome); the side-by-side stand test score ranges from 1 (best outcome) to 0 (worst outcome); the semi-tandem stand test score ranges from 1 (best outcome) to 0 (worst outcome); and the tandem stand test scores range from 2 (best outcome) to 0 (worst outcome).
  The total SPPB score is the sum of the test scores and ranges from 0-12, with lower scores indicating greater disability.
  measure: Change in Short Physical Performance Battery (SPPB) Scores
  time frame: Baseline, Week 28
  description: The SPPB comprises a gait speed test, a chair stand test, and three balance tests. The gait speed test score ranges from 0 (worst outcome) to 4 (best outcome); the chair stand test score ranges from 0 (worst outcome) to 4 (best outcome); the side-by-side stand test score ranges from 1 (best outcome) to 0 (worst outcome); the semi-tandem stand test score ranges from 1 (best outcome) to 0 (worst outcome); and the tandem stand test scores range from 2 (best outcome) to 0 (worst outcome).
  The total SPPB score is the sum of the test scores and ranges from 0-12, with lower scores indicating greater disability.
  measure: Change in Fat-Free Muscle Index
  time frame: Baseline, Week 13
  description: Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer.
  measure: Change in Fat-Free Muscle Index
  time frame: Baseline, Week 28
  description: Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer.
  measure: Change in Pre-Albumin Levels
  time frame: Baseline, Week 13
  description: Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples.
  measure: Change in Pre-Albumin Levels
  time frame: Baseline, Week 28
  description: Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples.
  arm group label: Control, then Swallowing Exercises + Protein
  arm group type: Experimental
  description: Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."
  arm group label: Control, then Swallowing Exercises
  arm group type: Active Comparator
  description: Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity."
  intervention type: Behavioral
  intervention name: Pharyngeal Swallowing Exercises
  description: 12-weeks of proactive pharyngeal swallowing exercises conducted 5 times per week. The exercise program will include the following four exercises: effortful saliva swallows, tongue-hold swallows, effortful pitch glides and posterior lingual resistance. Each exercise set will include 10 repetitions of each exercise (40 reps per set). The number of sets will be gradually increased as tolerance builds.
  arm group label: Control, then Swallowing Exercises
  arm group label: Control, then Swallowing Exercises + Protein
  intervention type: Dietary Supplement
  intervention name: Protein Supplementation
  description: 12-week supply of the commercially-available Premier Protein Clear ® High Protein (20 grams of protein and 90 calories per 16.9 oz. drink). Participants will be asked to consume one drink per day for the 12-week intervention period.
  arm group label: Control, then Swallowing Exercises + Protein
  intervention type: Device
  intervention name: MRI
  description: Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.
  arm group label: Control, then Swallowing Exercises
  arm group label: Control, then Swallowing Exercises + Protein
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sonja Molfenter
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: Sonja Molfenter
  phone: 212-992-7694
  email: Smm16@nyu.edu
  last name: Matina Balou
  phone: 646-754-1207
  email: Stamatela.Balou@nyulangone.org
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: smm16@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
  ipd access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to smm16@nyu.edu. To gain access, data requestors will need to sign a data access agreement.