<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/NCT03780309</url>
  </required_header>
  <id_info>
    <org_study_id>H15-277HHC</org_study_id>
    <nct_id>NCT03780309</nct_id>
  </id_info>
  <brief_title>Postexercise Hypotension and Exercise Adherence</brief_title>
  <official_title>Using the Immediate Blood Pressure Benefits of Exercise to Improve Exercise Adherence Among Adults With Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Connecticut</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hartford Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Connecticut</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>
      Sedentary (n=24) adults ≥18 yr with elevated BP to established hypertension were enrolled&#xD;
      into this randomized clinical trial entitled, 'Blood Pressure UtiLizing Self-Monitoring after&#xD;
      Exercise study or PULSE'. Participants were randomly assigned to either an exercise only&#xD;
      (EXERCISE; n=12) or exercise plus BP self-monitoring (EXERCISE+PEH) (n=12) group. All&#xD;
      participants participated in a 12 wk supervised moderate intensity aerobic exercise training&#xD;
      program 40 min/d for 3 d/wk. In addition, they were encouraged to exercise at home ≥30 min/d&#xD;
      for 1-2 d/wk. All participants self-monitored exercise with a traditional calendar recording&#xD;
      method and heart rate (HR) monitor. In addition to traditional exercise self-monitoring&#xD;
      (EXERCISE), individuals in the EXERCISE+PEH group were given a home BP monitor to assess home&#xD;
      BP twice daily (in the morning upon awakening and in the evening) and prior to and after&#xD;
      voluntary home exercise sessions. Resting BP, peak oxygen consumption (VO2peak), physical&#xD;
      activity, dietary and salt intake, and antihypertensive medication adherence were measured&#xD;
      before and after the 12 wk supervised exercise training program. In addition, integrated&#xD;
      social-cognitive predictors of exercise that included questionnaires on exercise&#xD;
      self-efficacy, barriers self-efficacy, outcome expectations for exercise, exercise intention,&#xD;
      and affective responses to exercise were measured before and after the 12 wk supervised&#xD;
      exercise training program. Four weeks following the completion of exercise training,&#xD;
      self-reported exercise levels were assessed during a telephone interview in both groups.&#xD;
      Among EXERCISE+PEH only, self-monitoring of BP was also self-reported during this telephone&#xD;
      interview.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 28, 2016</start_date>
  <completion_date type="Actual">May 29, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise Adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>Exercise adherence to the 12 wk supervised portion of the aerobic exercise training program was calculated as the percent of supervised exercise sessions completed divided by the total number of supervised sessions possible (# of supervised sessions performed ÷ total number of possible supervised sessions X 100%). In this calculation, the total number of possible sessions was calculated as: 3 supervised exercise training days per wk for 12 wk = 36 sessions with a maximum possible adherence of 100% (e.g., 36÷36 X 100% =100%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>The BP response to aerobic exercise training was calculated in two ways and in units 'mmHg': (1) in the laboratory (post training resting BP - pre training resting BP) during the control visits (Visits 1 or 2 vs. Visit 4 or 5); and (2) under ambulatory conditions (post training ambulatory BP - pre training ambulatory BP) following the control visits (Visits 1 or 2 vs. Visit 4 or 5) over the awake, sleep, and 19 hr.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise Training Characteristics: Frequency</measure>
    <time_frame>12 weeks</time_frame>
    <description>Exercise training frequency (d/wk) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Training Characteristics: Intensity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Exercise training intensity (%heart rate reserve) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Training Characteristics: Time</measure>
    <time_frame>12 weeks</time_frame>
    <description>Exercise training time (min) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Training Characteristics: Type</measure>
    <time_frame>12 weeks</time_frame>
    <description>Exercise training type (treadmill, cycle ergometer, elliptical) was recorded for unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Integrated social-cognitive predictor of exercise</measure>
    <time_frame>12 weeks</time_frame>
    <description>Participants were administered a validated questionnaire packet to assess whether EXERCISE and EXERCISE+PEH self-monitoring favorably modulated measures of integrated social-cognitive predictors of exercise (unitless).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Reported Physical activity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess self reported. physical activity (min).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>12 weeks</time_frame>
    <description>Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess dietary intake (kcal/d).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salt Intake</measure>
    <time_frame>12 weeks</time_frame>
    <description>Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess salt intake (mg/d).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antihypertensive Medication Adherence.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Participants taking antihypertensive medication were administered a validated questionnaire to assess antihypertensive medication adherence (%).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>EXERCISE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants participated in a the exercise training program and engaged in exercise self-monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EXERCISE+PEH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants participated in the exercise training program and engaged in exercise self-monitoring and blood pressure self-monitoring (daily and before and after exercise).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Self-Monitoring</intervention_name>
    <description>Participants engaged in exercise self-monitoring utilizing a traditional calendar recording method and heart rate monitor.</description>
    <arm_group_label>EXERCISE</arm_group_label>
    <arm_group_label>EXERCISE+PEH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Blood Pressure Self-Monitoring</intervention_name>
    <description>Participants engaged in blood pressure self-monitoring by measuring blood pressure twice daily and before and after exercise.</description>
    <arm_group_label>EXERCISE+PEH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 yr&#xD;
&#xD;
          -  SBP ≥130 mmHg or DBP ≥80 mmHg or taking antihypertensive medication regardless of BP&#xD;
             with a SBP &lt;160 mmHg and DBP &lt;100 mmHg&#xD;
&#xD;
          -  Free of diagnosed cardiovascular, pulmonary, renal, metabolic, or other chronic&#xD;
             diseases or depression&#xD;
&#xD;
          -  Non-smokers for at least 6 mo prior to entry&#xD;
&#xD;
          -  Consumed &lt;2 alcoholic drinks daily&#xD;
&#xD;
          -  Physically inactive defined as engaging in formal exercise ≤ 2d/wk.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking medications that influenced blood pressure such as inhaled or oral steroids,&#xD;
             nonsteroidal anti-inflammatory agents, aspirin, and nutritional supplements with the&#xD;
             exception of a 1-a-day vitamin, cold medications, and herbal supplements&#xD;
&#xD;
          -  Osteoarthritis and orthopedic problems that compromised ability to exercise.&#xD;
&#xD;
          -  Past medical history of cancer-related lymphedema&#xD;
&#xD;
          -  Seeking to gain or lose weight&#xD;
&#xD;
          -  Pregnant, lactating, or planning to become pregnant.&#xD;
&#xD;
          -  Hormone-altering contraception administered in a bolus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda S Pescatello, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Connecticut</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Connecticut</investigator_affiliation>
    <investigator_full_name>Linda Pescatello</investigator_full_name>
    <investigator_title>Board of Trustees Distinguished Professor</investigator_title>
  </responsible_party>
  <keyword>antihypertensive lifestyle therapy</keyword>
  <keyword>positive outcome expectations</keyword>
  <keyword>postexercise hypotension</keyword>
  <keyword>self-efficacy</keyword>
  <keyword>self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Post-Exercise Hypotension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03780309
org study id: H15-277HHC
nct id: NCT03780309
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sedentary (n=24) adults ≥18 yr with elevated BP to established hypertension were enrolled
      into this randomized clinical trial entitled, 'Blood Pressure UtiLizing Self-Monitoring after
      Exercise study or PULSE'. Participants were randomly assigned to either an exercise only
      (EXERCISE; n=12) or exercise plus BP self-monitoring (EXERCISE+PEH) (n=12) group. All
      participants participated in a 12 wk supervised moderate intensity aerobic exercise training
      program 40 min/d for 3 d/wk. In addition, they were encouraged to exercise at home ≥30 min/d
      for 1-2 d/wk. All participants self-monitored exercise with a traditional calendar recording
      method and heart rate (HR) monitor. In addition to traditional exercise self-monitoring
      (EXERCISE), individuals in the EXERCISE+PEH group were given a home BP monitor to assess home
      BP twice daily (in the morning upon awakening and in the evening) and prior to and after
      voluntary home exercise sessions. Resting BP, peak oxygen consumption (VO2peak), physical
      activity, dietary and salt intake, and antihypertensive medication adherence were measured
      before and after the 12 wk supervised exercise training program. In addition, integrated
      social-cognitive predictors of exercise that included questionnaires on exercise
      self-efficacy, barriers self-efficacy, outcome expectations for exercise, exercise intention,
      and affective responses to exercise were measured before and after the 12 wk supervised
      exercise training program. Four weeks following the completion of exercise training,
      self-reported exercise levels were assessed during a telephone interview in both groups.
      Among EXERCISE+PEH only, self-monitoring of BP was also self-reported during this telephone
      interview.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Exercise Adherence
time frame: 12 weeks
description: Exercise adherence to the 12 wk supervised portion of the aerobic exercise training program was calculated as the percent of supervised exercise sessions completed divided by the total number of supervised sessions possible (# of supervised sessions performed ÷ total number of possible supervised sessions X 100%). In this calculation, the total number of possible sessions was calculated as: 3 supervised exercise training days per wk for 12 wk = 36 sessions with a maximum possible adherence of 100% (e.g., 36÷36 X 100% =100%).
measure: Blood Pressure
time frame: 12 weeks
description: The BP response to aerobic exercise training was calculated in two ways and in units 'mmHg': (1) in the laboratory (post training resting BP - pre training resting BP) during the control visits (Visits 1 or 2 vs. Visit 4 or 5); and (2) under ambulatory conditions (post training ambulatory BP - pre training ambulatory BP) following the control visits (Visits 1 or 2 vs. Visit 4 or 5) over the awake, sleep, and 19 hr.
measure: Exercise Training Characteristics: Frequency
time frame: 12 weeks
description: Exercise training frequency (d/wk) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
measure: Exercise Training Characteristics: Intensity
time frame: 12 weeks
description: Exercise training intensity (%heart rate reserve) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
measure: Exercise Training Characteristics: Time
time frame: 12 weeks
description: Exercise training time (min) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
measure: Exercise Training Characteristics: Type
time frame: 12 weeks
description: Exercise training type (treadmill, cycle ergometer, elliptical) was recorded for unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
measure: Integrated social-cognitive predictor of exercise
time frame: 12 weeks
description: Participants were administered a validated questionnaire packet to assess whether EXERCISE and EXERCISE+PEH self-monitoring favorably modulated measures of integrated social-cognitive predictors of exercise (unitless).
measure: Self Reported Physical activity
time frame: 12 weeks
description: Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess self reported. physical activity (min).
measure: Dietary Intake
time frame: 12 weeks
description: Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess dietary intake (kcal/d).
measure: Salt Intake
time frame: 12 weeks
description: Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess salt intake (mg/d).
measure: Antihypertensive Medication Adherence.
time frame: 12 weeks
description: Participants taking antihypertensive medication were administered a validated questionnaire to assess antihypertensive medication adherence (%).
arm group label: EXERCISE
arm group type: Active Comparator
description: Participants participated in a the exercise training program and engaged in exercise self-monitoring.
arm group label: EXERCISE+PEH
arm group type: Experimental
description: Participants participated in the exercise training program and engaged in exercise self-monitoring and blood pressure self-monitoring (daily and before and after exercise).
intervention type: Behavioral
intervention name: Exercise Self-Monitoring
description: Participants engaged in exercise self-monitoring utilizing a traditional calendar recording method and heart rate monitor.
arm group label: EXERCISE
arm group label: EXERCISE+PEH
intervention type: Behavioral
intervention name: Blood Pressure Self-Monitoring
description: Participants engaged in blood pressure self-monitoring by measuring blood pressure twice daily and before and after exercise.
arm group label: EXERCISE+PEH
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Linda S Pescatello, PhD
role: Principal Investigator
affiliation: University of Connecticut
responsible party type: Principal Investigator
investigator affiliation: University of Connecticut
investigator full name: Linda Pescatello
investigator title: Board of Trustees Distinguished Professor
mesh term: Post-Exercise Hypotension
mesh term: Hypertension
sharing ipd: Undecided