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/NCT06042439</url>
    </required_header>
    <id_info>
      <org_study_id>R01HL164575-Study3</org_study_id>
      <secondary_id>1R01HL164575-01A1</secondary_id>
      <nct_id>NCT06042439</nct_id>
    </id_info>
    <brief_title>AM vs PM Exercise Training</brief_title>
    <official_title>Effects of AM vs. PM Exercise Training on Blood Pressure and Vascular Health in Postmenopausal Females With Hypertension</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Michigan State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Michigan State University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The treatment of high blood pressure, or hypertension, is multifaceted and can include&#xD;
        pharmacological therapies (i.e., medications) and lifestyle modifications such as physical&#xD;
        activity. Chronotherapy, which describes timing of a treatment with the body's daily rhythms,&#xD;
        has recently been used with hypertension medications and has been shown to be effective at&#xD;
        lowering blood pressure and reducing the risk of cardiovascular disease events. Specifically,&#xD;
        taking medications in the evening was shown to be more effective than morning medication&#xD;
        routines. Little information is available about the effectiveness of chronotherapy combined&#xD;
        with exercise (i.e., planned physical activity) interventions in older adults with&#xD;
        hypertension. The purpose of this study is to examine how exercise training performed in the&#xD;
        morning and early evening affects blood pressure and other measures of blood vessel health in&#xD;
        postmenopausal females with hypertension.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Blood pressure has an internal rhythm associated with the 24-hr clock. Nocturnal blood&#xD;
        pressure (BP) is a key contributor to cardiovascular health and may be improved by exercise.&#xD;
        Moreover, the time of day of the exercise may be a key factor. This study aims to evaluate&#xD;
        the effects of morning and evening exercise training on BP and other measures of vascular&#xD;
        function in older females with hypertension.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">June 2026</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Nocturnal systolic blood pressure (BP)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Reduction in systolic nocturnal BP (Pre-training - Post-training)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Endothelial function</measure>
      <time_frame>6 weeks</time_frame>
      <description>Increase in flow mediated dilation of the brachial artery (Post-training - Pre-training)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microvascular function</measure>
      <time_frame>6 weeks</time_frame>
      <description>Increase in rapid onset vasodilation of the popliteal artery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ambulatory blood pressure</measure>
      <time_frame>6 weeks</time_frame>
      <description>Reduction in systolic and diastolic BPs over a 24-hr period (Pre-training - Post-training)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arterial stiffness</measure>
      <time_frame>6 weeks</time_frame>
      <description>Reduction in carotid femoral pulse wave velocity (Pre-training - Post-training)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">79</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Morning (AM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exercise starting before 10:01 AM</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Evening (PM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exercise starting after 3:59 PM</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>6 weeks of exercise training (Pre-training)</intervention_name>
      <description>handgrip and treadmill walking 4 days per week</description>
      <arm_group_label>Evening (PM)</arm_group_label>
      <arm_group_label>Morning (AM)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>6 weeks of exercise training (Post-training)</intervention_name>
      <description>handgrip and treadmill walking 4 days per week</description>
      <arm_group_label>Evening (PM)</arm_group_label>
      <arm_group_label>Morning (AM)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Systolic BP equal to or greater than 130 mmHg without BP medication or greater than&#xD;
               120 mmHg with medication and diastolic blood pressure equal to and greater than 80&#xD;
               mmHg&#xD;
  &#xD;
            -  55-80 years old&#xD;
  &#xD;
            -  Post-menopausal female&#xD;
  &#xD;
            -  Able to walk without assistance&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Habitually physically active defined as 150 minutes of moderate-intensity or 75&#xD;
               minutes of vigorous-intensity aerobic physical activity per week&#xD;
  &#xD;
            -  Overt pulmonary disease/condition as follows: chronic bronchitis, chronic obstructive&#xD;
               pulmonary disease, emphysema, or pulmonary hypertension&#xD;
  &#xD;
            -  Cardiometabolic disease/condition as follows: diabetes, heart failure, peripheral&#xD;
               arterial disease, stroke, coronary artery disease, renal disease, secondary&#xD;
               hypertension, chronic venous insufficiency or deep vein thrombosis within last 6&#xD;
               months&#xD;
  &#xD;
            -  Cancer within last 5 years&#xD;
  &#xD;
            -  Body mass index &gt;39 kg/m2&#xD;
  &#xD;
            -  Current smoking or vape&#xD;
  &#xD;
            -  Evening shift work&#xD;
  &#xD;
            -  uncontrolled thyroid disorder&#xD;
  &#xD;
            -  2 or more falls in the last year&#xD;
  &#xD;
            -  Anemia within 3 months of enrollment&#xD;
  &#xD;
            -  Parkinson's disease&#xD;
  &#xD;
            -  Dementia&#xD;
  &#xD;
            -  Unstable angina&#xD;
  &#xD;
            -  Acute pulmonary embolus or infarction&#xD;
  &#xD;
            -  Acute myocarditis or pericarditis&#xD;
  &#xD;
            -  Acute aortic dissection&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jill Slade, PhD</last_name>
      <phone>5178843351</phone>
      <email>jslade@msu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Katharine Currie, PhD</last_name>
      <phone>517-432-4073</phone>
      <email>curriek4@msu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Michigan State University</name>
        <address>
          <city>East Lansing</city>
          <state>Michigan</state>
          <zip>48824</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jill Slade, PhD</last_name>
        <phone>517-884-3351</phone>
        <email>jslade@msu.edu</email>
      </contact>
      <contact_backup>
        <last_name>Katharine Currie, PhD</last_name>
        <phone>517-432-4073</phone>
        <email>curriek4@msu.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Michigan State University</investigator_affiliation>
      <investigator_full_name>Katharine Currie</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06042439
  org study id: R01HL164575-Study3
  secondary id: 1R01HL164575-01A1
  nct id: NCT06042439
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The treatment of high blood pressure, or hypertension, is multifaceted and can include
        pharmacological therapies (i.e., medications) and lifestyle modifications such as physical
        activity. Chronotherapy, which describes timing of a treatment with the body's daily rhythms,
        has recently been used with hypertension medications and has been shown to be effective at
        lowering blood pressure and reducing the risk of cardiovascular disease events. Specifically,
        taking medications in the evening was shown to be more effective than morning medication
        routines. Little information is available about the effectiveness of chronotherapy combined
        with exercise (i.e., planned physical activity) interventions in older adults with
        hypertension. The purpose of this study is to examine how exercise training performed in the
        morning and early evening affects blood pressure and other measures of blood vessel health in
        postmenopausal females with hypertension.
  Blood pressure has an internal rhythm associated with the 24-hr clock. Nocturnal blood
        pressure (BP) is a key contributor to cardiovascular health and may be improved by exercise.
        Moreover, the time of day of the exercise may be a key factor. This study aims to evaluate
        the effects of morning and evening exercise training on BP and other measures of vascular
        function in older females with hypertension.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Nocturnal systolic blood pressure (BP)
  time frame: 6 weeks
  description: Reduction in systolic nocturnal BP (Pre-training - Post-training)
  measure: Endothelial function
  time frame: 6 weeks
  description: Increase in flow mediated dilation of the brachial artery (Post-training - Pre-training)
  measure: Microvascular function
  time frame: 6 weeks
  description: Increase in rapid onset vasodilation of the popliteal artery
  measure: Ambulatory blood pressure
  time frame: 6 weeks
  description: Reduction in systolic and diastolic BPs over a 24-hr period (Pre-training - Post-training)
  measure: Arterial stiffness
  time frame: 6 weeks
  description: Reduction in carotid femoral pulse wave velocity (Pre-training - Post-training)
  arm group label: Morning (AM)
  arm group type: Experimental
  description: Exercise starting before 10:01 AM
  arm group label: Evening (PM)
  arm group type: Experimental
  description: Exercise starting after 3:59 PM
  intervention type: Behavioral
  intervention name: 6 weeks of exercise training (Pre-training)
  description: handgrip and treadmill walking 4 days per week
  arm group label: Evening (PM)
  arm group label: Morning (AM)
  intervention type: Behavioral
  intervention name: 6 weeks of exercise training (Post-training)
  description: handgrip and treadmill walking 4 days per week
  arm group label: Evening (PM)
  arm group label: Morning (AM)
  criteria: 
  gender: Female
  minimum age: 55 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jill Slade, PhD
  phone: 5178843351
  email: jslade@msu.edu
  last name: Katharine Currie, PhD
  phone: 517-432-4073
  email: curriek4@msu.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Michigan State University
  investigator full name: Katharine Currie
  investigator title: Assistant Professor
  mesh term: Hypertension
  sharing ipd: No