<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/NCT03750006</url>
  </required_header>
  <id_info>
    <org_study_id>E2902-P</org_study_id>
    <secondary_id>RX002902</secondary_id>
    <nct_id>NCT03750006</nct_id>
  </id_info>
  <brief_title>Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training</brief_title>
  <acronym>HIIT-VA</acronym>
  <official_title>Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Western New York Healthcare System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University at Buffalo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Frailty is a clinical condition of poor physiological reserve that increases risks for&#xD;
      adverse health outcomes including falls, hospitalization and mortality. Exercise is&#xD;
      beneficial for the prevention and even reversal of frailty, yet participation among older&#xD;
      individuals is limited. Short session high intensity interval training (HIIT) is emerging as&#xD;
      a promising exercise strategy that achieves performance gains with lower time commitment. The&#xD;
      goal of this pilot proposal is to establish the feasibility of HIIT exercise training&#xD;
      protocols in 65-85 year old individuals, as well as to demonstrate the ability to detect&#xD;
      functional and physiologic benefits. The investigators anticipate the preliminary research&#xD;
      findings will lay the foundation for future human clinical studies that will permit us to&#xD;
      significantly improve the health of Veterans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enhancing functional capacity in older adults with short session high intensity interval&#xD;
      training&#xD;
&#xD;
      Frailty is a condition of poor physiological reserve that increases susceptibility to falls,&#xD;
      hospitalization, disability and mortality. The incidence of frailty rapidly increases after&#xD;
      the age 65, growing from 10% to as many as 50% of those 85 years or older; therefore over 9&#xD;
      million Veterans are either frail or at risk for frailty. Exercise has proven benefits for&#xD;
      frailty, yet older adults rarely attain the recommended 150 minutes a week of moderate&#xD;
      intensity exercise. High intensity interval training (HIIT) is emerging as an alternative as&#xD;
      it delivers similar or better gains than moderate intensity exercise in less time. Recently,&#xD;
      the investigators published that a 3-day-a-week, 10-minute HIIT regimen in aged mice not only&#xD;
      reduces frailty, but leads to both strength and endurance benefits. In addition, the&#xD;
      preliminary data demonstrate significant changes in microRNA (miRNA) profiles. Despite the&#xD;
      potential of short session HIIT to improve functional capacity and lead to better adherence,&#xD;
      the modality has not been tested in individuals 65-85 years of age, and in particular, frail&#xD;
      individuals. The goals of this proposal are to: 1) investigate the feasibility of recruiting&#xD;
      and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2)&#xD;
      to characterize the physical performance benefits and serum microRNA (miRNA) profiles in&#xD;
      those participants.&#xD;
&#xD;
      To accomplish these goals the investigators will administer a short session HIIT regimen&#xD;
      totaling only 10-minutes, 3-days-a-week for 3 months, using recumbent exercise cycles, to&#xD;
      65-85 year old participants. The investigators will also utilize next generation RNA sequence&#xD;
      technology to assess HIIT impacts upon microRNA profiles in serum samples. The investigators&#xD;
      anticipate this project will demonstrate the feasibility of administering short session HIIT&#xD;
      to older individuals, including vulnerable frail and pre-frail populations as well as&#xD;
      demonstrate the ability to collect and analyze serum miRNA profiles. The advantages to this&#xD;
      program are the ability to maintain or build muscle mass and improve aerobic conditioning,&#xD;
      especially in older patients where frailty and sarcopenia are so prevalent. This pilot&#xD;
      project will therefore lay the foundation for future clinical trials that further explore the&#xD;
      utility of HIIT to prevent or delay the onset of frailty in larger cohorts, and ultimately&#xD;
      lead to the enhancement of functional capacity and quality of life in aging Veteran&#xD;
      populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <intervention_model_description>The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline VO2 Max at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>VO2 max, also known as maximal oxygen uptake, will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in physical activity enjoyment at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 subscales, each of which can receive a score from 1 to 7. Therefore the total range of the test spans summed scores from 18 to 126.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the SPPB at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, including balance, side-by-side/semi-tandem/tandem stands, and gait speed. There are 3 subscales, each of which can receive up to 4 points. Therefore the total range of the test spans summed scores from 1 to 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in frailty phenotype at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>Fried frailty phenotype assessment including: gait speed, grip strength, endurance, activity level, weight loss.&#xD;
These scales report summed scores of 0 to 5. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) fof the age and gender adjusted range, then it is given a score of &quot;1&quot;. If both questions on the endurance or activity measures are positive then then it is given a score of &quot;1&quot;. If weight loss is greater than 5% over the past year, then it is given a score of &quot;1&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Quality of Life at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5. Therefore the total range of the test spans scores from 14 to 70.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in cognition at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>VA-SLUMS: VA Saint Louis University Mental Status screen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Activities of Daily Living &amp; Instrumental Activities of Daily Living at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>ADLs: dressing, eating, ambulation, toileting, and hygiene IADLs: shopping, housework, accounting, food preparation, transportation/telephone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in microRNA profiling at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>Next Generation Sequencing of microRNA species from serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum 25-hydroxy-vitamin D</measure>
    <time_frame>baseline</time_frame>
    <description>serum 25-hydroxy-vitamin D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in C-reactive protein level at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in quadriceps strength at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in newtons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 6 minute walk distance at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>6 minute walk distance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in FRAIL scale at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>FRAIL scale: fatiguability, resistance, ambulation, illnesses, loss of weight. If the answers to any of the questions is yes, then given score is &quot;1&quot; with a total survey range of 0 to 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in interleukin-6 level at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>Interleukin-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in interleukin-10 level at 3 months</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>Interleukin-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fNIRS</measure>
    <time_frame>baseline and at participant completion, an average of 3 months</time_frame>
    <description>functional near infra-red spectroscopy to analyze muscle blood flow in the quadriceps during VO2max test</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>HIIT intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Short session HIIT</intervention_name>
    <description>Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.</description>
    <arm_group_label>HIIT intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Any race&#xD;
&#xD;
          -  Frail, pre-frail, and non-frail&#xD;
&#xD;
          -  Medical clearance for exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe co-morbidity (e.g. - CHF (class III), COPD (GOLD stage IV), CKD (stage 3))&#xD;
&#xD;
          -  VAMC SLUMS score 20&#xD;
&#xD;
          -  Physical impairment that prevents use of a recumbent exercise bike&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce R. Troen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Western New York Healthcare System, Buffalo, NY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Western New York Healthcare System, Buffalo, NY</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>frailty</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>exercise</keyword>
  <keyword>high intensity</keyword>
  <keyword>older adults</keyword>
  <keyword>microRNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Thus, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; (c) restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource, and (d) a commitment to destroying or returning the data after analyses are completed. De identified data will be maintained on a VA server and will only be shared via encrypted devices. Co-Investigators will have access to the data collected as part of their aims. Investigators working on the grant will have access to the data through the PI. The data will be monitored routinely to maintain safety and productivity, as well as to assist with research dissemination annually.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Six months after publication.</ipd_time_frame>
    <ipd_access_criteria>Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>April 17, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03750006
org study id: E2902-P
secondary id: RX002902
nct id: NCT03750006
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Frailty is a clinical condition of poor physiological reserve that increases risks for
      adverse health outcomes including falls, hospitalization and mortality. Exercise is
      beneficial for the prevention and even reversal of frailty, yet participation among older
      individuals is limited. Short session high intensity interval training (HIIT) is emerging as
      a promising exercise strategy that achieves performance gains with lower time commitment. The
      goal of this pilot proposal is to establish the feasibility of HIIT exercise training
      protocols in 65-85 year old individuals, as well as to demonstrate the ability to detect
      functional and physiologic benefits. The investigators anticipate the preliminary research
      findings will lay the foundation for future human clinical studies that will permit us to
      significantly improve the health of Veterans.
Enhancing functional capacity in older adults with short session high intensity interval
      training

      Frailty is a condition of poor physiological reserve that increases susceptibility to falls,
      hospitalization, disability and mortality. The incidence of frailty rapidly increases after
      the age 65, growing from 10% to as many as 50% of those 85 years or older; therefore over 9
      million Veterans are either frail or at risk for frailty. Exercise has proven benefits for
      frailty, yet older adults rarely attain the recommended 150 minutes a week of moderate
      intensity exercise. High intensity interval training (HIIT) is emerging as an alternative as
      it delivers similar or better gains than moderate intensity exercise in less time. Recently,
      the investigators published that a 3-day-a-week, 10-minute HIIT regimen in aged mice not only
      reduces frailty, but leads to both strength and endurance benefits. In addition, the
      preliminary data demonstrate significant changes in microRNA (miRNA) profiles. Despite the
      potential of short session HIIT to improve functional capacity and lead to better adherence,
      the modality has not been tested in individuals 65-85 years of age, and in particular, frail
      individuals. The goals of this proposal are to: 1) investigate the feasibility of recruiting
      and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2)
      to characterize the physical performance benefits and serum microRNA (miRNA) profiles in
      those participants.

      To accomplish these goals the investigators will administer a short session HIIT regimen
      totaling only 10-minutes, 3-days-a-week for 3 months, using recumbent exercise cycles, to
      65-85 year old participants. The investigators will also utilize next generation RNA sequence
      technology to assess HIIT impacts upon microRNA profiles in serum samples. The investigators
      anticipate this project will demonstrate the feasibility of administering short session HIIT
      to older individuals, including vulnerable frail and pre-frail populations as well as
      demonstrate the ability to collect and analyze serum miRNA profiles. The advantages to this
      program are the ability to maintain or build muscle mass and improve aerobic conditioning,
      especially in older patients where frailty and sarcopenia are so prevalent. This pilot
      project will therefore lay the foundation for future clinical trials that further explore the
      utility of HIIT to prevent or delay the onset of frailty in larger cohorts, and ultimately
      lead to the enhancement of functional capacity and quality of life in aging Veteran
      populations.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline VO2 Max at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: VO2 max, also known as maximal oxygen uptake, will be assessed.
measure: Change from baseline in physical activity enjoyment at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 subscales, each of which can receive a score from 1 to 7. Therefore the total range of the test spans summed scores from 18 to 126.
measure: Change from baseline in the SPPB at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, including balance, side-by-side/semi-tandem/tandem stands, and gait speed. There are 3 subscales, each of which can receive up to 4 points. Therefore the total range of the test spans summed scores from 1 to 12.
measure: Change from baseline in frailty phenotype at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: Fried frailty phenotype assessment including: gait speed, grip strength, endurance, activity level, weight loss.
These scales report summed scores of 0 to 5. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) fof the age and gender adjusted range, then it is given a score of "1". If both questions on the endurance or activity measures are positive then then it is given a score of "1". If weight loss is greater than 5% over the past year, then it is given a score of "1".
measure: Change from baseline in Quality of Life at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5. Therefore the total range of the test spans scores from 14 to 70.
measure: Change from baseline in cognition at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: VA-SLUMS: VA Saint Louis University Mental Status screen.
measure: Change from baseline in Activities of Daily Living & Instrumental Activities of Daily Living at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: ADLs: dressing, eating, ambulation, toileting, and hygiene IADLs: shopping, housework, accounting, food preparation, transportation/telephone
measure: Change from baseline in microRNA profiling at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: Next Generation Sequencing of microRNA species from serum.
measure: serum 25-hydroxy-vitamin D
time frame: baseline
description: serum 25-hydroxy-vitamin D
measure: Change from baseline in C-reactive protein level at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: C-reactive protein
measure: Change from baseline in quadriceps strength at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in newtons.
measure: Change from baseline in 6 minute walk distance at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: 6 minute walk distance
measure: Change from baseline in FRAIL scale at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: FRAIL scale: fatiguability, resistance, ambulation, illnesses, loss of weight. If the answers to any of the questions is yes, then given score is "1" with a total survey range of 0 to 5.
measure: Change from baseline in interleukin-6 level at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: Interleukin-6
measure: Change from baseline in interleukin-10 level at 3 months
time frame: baseline and at participant completion, an average of 3 months
description: Interleukin-10
measure: fNIRS
time frame: baseline and at participant completion, an average of 3 months
description: functional near infra-red spectroscopy to analyze muscle blood flow in the quadriceps during VO2max test
arm group label: HIIT intervention
arm group type: Experimental
description: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
intervention type: Behavioral
intervention name: Short session HIIT
description: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
arm group label: HIIT intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bruce R. Troen, MD
role: Principal Investigator
affiliation: VA Western New York Healthcare System, Buffalo, NY
facility: 
country: United States
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: Yes
ipd description: Thus, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; (c) restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource, and (d) a commitment to destroying or returning the data after analyses are completed. De identified data will be maintained on a VA server and will only be shared via encrypted devices. Co-Investigators will have access to the data collected as part of their aims. Investigators working on the grant will have access to the data through the PI. The data will be monitored routinely to maintain safety and productivity, as well as to assist with research dissemination annually.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Six months after publication.
ipd access criteria: Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.
submitted: April 17, 2023