<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/NCT03266510</url>
  </required_header>
  <id_info>
    <org_study_id>17-0151</org_study_id>
    <nct_id>NCT03266510</nct_id>
  </id_info>
  <brief_title>Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function</brief_title>
  <official_title>Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Douglas Seals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Boulder</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 purpose of this study is to assess the efficacy of inspiratory muscle strength training&#xD;
      for lowering blood pressure and improving physiological function (vascular, motor, and&#xD;
      cognitive) in middle-aged and older adults with elevated systolic blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over, the proposed research project has the long-term potential to influence clinical&#xD;
      practice by establishing a novel lifestyle intervention for treating multiple domains of age-&#xD;
      and hypertension-associated physiological dysfunction and thereby reducing the risk of&#xD;
      clinical disease and disability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 25, 2017</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 14, 2020</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>6 weeks</time_frame>
    <description>Resting blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ambulatory blood pressure</measure>
    <time_frame>6 weeks</time_frame>
    <description>24-hour mean blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelium-dependent dilation</measure>
    <time_frame>6 weeks</time_frame>
    <description>Flow-mediated dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial stiffness</measure>
    <time_frame>6 weeks</time_frame>
    <description>Aortic pulse wave velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor function</measure>
    <time_frame>6 weeks</time_frame>
    <description>NIH Toolbox motor test battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>6 weeks</time_frame>
    <description>NIH Toolbox cognition test battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic markers of oxidative stress</measure>
    <time_frame>6 weeks</time_frame>
    <description>Oxidized LDL levels in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial cell markers of oxidative stress</measure>
    <time_frame>6 weeks</time_frame>
    <description>Nitrotyrosine levels in biopsied endothelial cells</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Hypertension</condition>
  <condition>Prehypertension</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Inspiratory muscle strength training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be strong.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham training</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Using a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be weak.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspiratory muscle strength training</intervention_name>
    <description>Subjects will perform inspiratory muscle strength training for 6 weeks.</description>
    <arm_group_label>Inspiratory muscle strength training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham training</intervention_name>
    <description>Subjects will perform sham training for 6 weeks.</description>
    <arm_group_label>Sham training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Willing to accept random assignment to condition&#xD;
&#xD;
          -  Women will be confirmed as postmenopausal (either natural or surgical) based on&#xD;
             cessation of menses for &gt;1 year.&#xD;
&#xD;
          -  Resting systolic blood pressure 120-159 mmHg&#xD;
&#xD;
          -  Resting diastolic blood pressure &lt;100 mmHg&#xD;
&#xD;
          -  Subjects taking anti-hypertensive medications will be included provided they meet the&#xD;
             other inclusion criteria, including elevated systolic blood pressure. These&#xD;
             medications will not be withheld prior to experimental protocols.&#xD;
&#xD;
          -  Free from alcohol dependence or abuse, as defined by the American Psychiatry&#xD;
             Association, Diagnostic and Statistical Manual or Mental Disorders (DSM-IV)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smoking&#xD;
&#xD;
          -  Chronic clinical disease (e.g., inflammatory bowel disease/irritable bowel syndrome,&#xD;
             coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney&#xD;
             disease requiring dialysis, neurological disorders or diseases that may affect&#xD;
             motor/cognitive function [multiple sclerosis, Parkinson's disease, polio, Alzheimer's&#xD;
             disease, dementia, or other brain diseases of aging]), except hypertension&#xD;
&#xD;
          -  Postmenopausal &lt;1 year&#xD;
&#xD;
          -  Scoring &lt;21 on the mini-mental state examination&#xD;
&#xD;
          -  Moderate or sever peripheral artery disease (ankle-brachial index 0.7)&#xD;
&#xD;
          -  Taking a medication that your doctor deems unsafe to hold for &gt;1 week&#xD;
&#xD;
          -  A graded exercise test will be performed by all subjects. If there is physician&#xD;
             concern or an adverse event, the subject will not participate in the study.&#xD;
&#xD;
          -  No weight stable in the prior 3 months (&gt;2 kg weight change) or unwilling to remain&#xD;
             weight stable throughout study (rationale: recent weight change or weight loss can&#xD;
             influence vascular function)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel H Craighead, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Douglas R Seals, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Integrative Physiology of Aging Laboratory</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.colorado.edu/intphys/research/cardiovascular.html</url>
    <description>Description of our Research Laboratory</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Colorado, Boulder</investigator_affiliation>
    <investigator_full_name>Douglas Seals</investigator_full_name>
    <investigator_title>Professor of Distinction</investigator_title>
  </responsible_party>
  <keyword>Inspiratory muscle strength training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Prehypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 24, 2021</submitted>
    <returned>October 22, 2021</returned>
    <submitted>December 10, 2021</submitted>
    <returned>March 3, 2022</returned>
  </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/NCT03266510
org study id: 17-0151
nct id: NCT03266510
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the efficacy of inspiratory muscle strength training
      for lowering blood pressure and improving physiological function (vascular, motor, and
      cognitive) in middle-aged and older adults with elevated systolic blood pressure.
Over, the proposed research project has the long-term potential to influence clinical
      practice by establishing a novel lifestyle intervention for treating multiple domains of age-
      and hypertension-associated physiological dysfunction and thereby reducing the risk of
      clinical disease and disability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Blood pressure
time frame: 6 weeks
description: Resting blood pressure
measure: Ambulatory blood pressure
time frame: 6 weeks
description: 24-hour mean blood pressure
measure: Endothelium-dependent dilation
time frame: 6 weeks
description: Flow-mediated dilation
measure: Arterial stiffness
time frame: 6 weeks
description: Aortic pulse wave velocity
measure: Motor function
time frame: 6 weeks
description: NIH Toolbox motor test battery
measure: Cognitive function
time frame: 6 weeks
description: NIH Toolbox cognition test battery
measure: Systemic markers of oxidative stress
time frame: 6 weeks
description: Oxidized LDL levels in blood
measure: Endothelial cell markers of oxidative stress
time frame: 6 weeks
description: Nitrotyrosine levels in biopsied endothelial cells
arm group label: Inspiratory muscle strength training
arm group type: Experimental
description: Using a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be strong.
arm group label: Sham training
arm group type: Sham Comparator
description: Using a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be weak.
intervention type: Other
intervention name: Inspiratory muscle strength training
description: Subjects will perform inspiratory muscle strength training for 6 weeks.
arm group label: Inspiratory muscle strength training
intervention type: Other
intervention name: Sham training
description: Subjects will perform sham training for 6 weeks.
arm group label: Sham training
criteria: 
gender: All
minimum age: 50 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel H Craighead, PhD
role: Principal Investigator
affiliation: University of Colorado, Boulder
last name: Douglas R Seals, PhD
role: Study Director
affiliation: University of Colorado, Boulder
facility: 
country: United States
url: http://www.colorado.edu/intphys/research/cardiovascular.html
description: Description of our Research Laboratory
responsible party type: Sponsor-Investigator
investigator affiliation: University of Colorado, Boulder
investigator full name: Douglas Seals
investigator title: Professor of Distinction
mesh term: Respiratory Aspiration
mesh term: Prehypertension
sharing ipd: No
submitted: September 24, 2021
returned: October 22, 2021
submitted: December 10, 2021
returned: March 3, 2022