<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/NCT03254251</url>
  </required_header>
  <id_info>
    <org_study_id>PusanNU-3</org_study_id>
    <nct_id>NCT03254251</nct_id>
  </id_info>
  <brief_title>The Effects of Stair Climbing on Arterial Stiffness, Blood Pressure and Leg Strength in Stage-1 Postmenopausal Women</brief_title>
  <official_title>The Effects of a 12-week Stair Climbing Regimen on Arterial Stiffness, BP and Leg Strength in Stage-1 Hypertensive Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dong-Eui University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pusan National University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We used a parallel experimental design. Following an initial screening and familiarization&#xD;
      session of study tests and procedures, eligible postmenopausal women were randomly assigned&#xD;
      to a stair climbing (SC) group or non-exercising control group. SC training session was&#xD;
      progressive program, and was performed 4 days a week for 12 weeks. Measurements were&#xD;
      collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning&#xD;
      following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48&#xD;
      and 72 hours after the last exercise session.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">April 10, 2017</completion_date>
  <primary_completion_date type="Actual">April 3, 2017</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arterial stiffness</measure>
    <time_frame>12 weeks</time_frame>
    <description>Arterial stiff ness was measured by brachial to ankle pulse wave velocity (baPWV, m/s) using volume plethysmographic device (VP-1000).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure (BP)</measure>
    <time_frame>12 weeks</time_frame>
    <description>BP (mmHg) was measured by volume plethysmographic device. Diastolic blood pressure and systolic blood pressure were measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>12 weeks</time_frame>
    <description>Muscle strength was measured by the eight repetition maximum (8RM) test using extension machine (Cyber 6000).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body composition was measured using eight-polar tactile-electrode impedance meter (InBody 720). Body weight (kg), fat mass (kg), and fat free mass (kg) were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height</measure>
    <time_frame>12 weeks</time_frame>
    <description>Height (m) was measured with a stadiometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate (HR)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Heart rate was measured by ECG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>BMI was calculated as weight/height^2 (kg/m^2)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Hypertension</condition>
  <condition>Menopause</condition>
  <arm_group>
    <arm_group_label>Stair Climbing (SC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N=20, 12 weeks of stair climbing exercise training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Exercise (CON)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>N=21, No exercise for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stair climbing</intervention_name>
    <description>Stair climbing (SC) training was 12 weeks of progressive SC program. Each training session consisted of a general warm-up (5 min: slow and fast skipping, stretching) followed by the SC training and was supervised by experienced personnel. The program began with two bouts of stair climbing four days a week in weeks 1 and 2, increasing by one climb a day every three weeks. By the last three weeks (10-12) of the study, all subjects were completing 5 climbs four days a week. During each climb participants ascended 12 flights (192 steps) divided into 3 sets of 4 flights, with a 2 min rest period between each set. There was a 5 min rest period between climbs that allowed the participants to reach the ground floor using an elevator. Subjects in the non-exercising control group did not participate in a supervised exercise program for the duration of the study.</description>
    <arm_group_label>Stair Climbing (SC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage-1 hypertension&#xD;
&#xD;
          -  Postmenopausal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pulmonary, renal, adrenal, pituitary, severe psychiatric, thyroid, or cardiovascular&#xD;
             disease other than stage-1 systolic hypertension (140-159 mmHg)&#xD;
&#xD;
          -  Hormone replacement therapy during the 6 months prior the study&#xD;
&#xD;
          -  Smoker or having any medication changes in the previous year&#xD;
&#xD;
          -  Experience with psychological and physical therapy in the previous year&#xD;
&#xD;
          -  History of steady exercise or exercise training in the last year&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>58 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>October 30, 2020</last_update_submitted>
  <last_update_submitted_qc>October 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University</investigator_affiliation>
    <investigator_full_name>Won-mok son</investigator_full_name>
    <investigator_title>postdoctoral fellow</investigator_title>
  </responsible_party>
  <!-- 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/NCT03254251
org study id: PusanNU-3
nct id: NCT03254251
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
We used a parallel experimental design. Following an initial screening and familiarization
      session of study tests and procedures, eligible postmenopausal women were randomly assigned
      to a stair climbing (SC) group or non-exercising control group. SC training session was
      progressive program, and was performed 4 days a week for 12 weeks. Measurements were
      collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning
      following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48
      and 72 hours after the last exercise session.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Arterial stiffness
time frame: 12 weeks
description: Arterial stiff ness was measured by brachial to ankle pulse wave velocity (baPWV, m/s) using volume plethysmographic device (VP-1000).
measure: Blood pressure (BP)
time frame: 12 weeks
description: BP (mmHg) was measured by volume plethysmographic device. Diastolic blood pressure and systolic blood pressure were measured.
measure: Muscle strength
time frame: 12 weeks
description: Muscle strength was measured by the eight repetition maximum (8RM) test using extension machine (Cyber 6000).
measure: Body composition
time frame: 12 weeks
description: Body composition was measured using eight-polar tactile-electrode impedance meter (InBody 720). Body weight (kg), fat mass (kg), and fat free mass (kg) were assessed.
measure: Height
time frame: 12 weeks
description: Height (m) was measured with a stadiometer
measure: Heart rate (HR)
time frame: 12 weeks
description: Heart rate was measured by ECG
measure: Body mass index (BMI)
time frame: 12 weeks
description: BMI was calculated as weight/height^2 (kg/m^2)
arm group label: Stair Climbing (SC)
arm group type: Experimental
description: N=20, 12 weeks of stair climbing exercise training.
arm group label: No Exercise (CON)
arm group type: No Intervention
description: N=21, No exercise for 12 weeks
intervention type: Behavioral
intervention name: Stair climbing
description: Stair climbing (SC) training was 12 weeks of progressive SC program. Each training session consisted of a general warm-up (5 min: slow and fast skipping, stretching) followed by the SC training and was supervised by experienced personnel. The program began with two bouts of stair climbing four days a week in weeks 1 and 2, increasing by one climb a day every three weeks. By the last three weeks (10-12) of the study, all subjects were completing 5 climbs four days a week. During each climb participants ascended 12 flights (192 steps) divided into 3 sets of 4 flights, with a 2 min rest period between each set. There was a 5 min rest period between climbs that allowed the participants to reach the ground floor using an elevator. Subjects in the non-exercising control group did not participate in a supervised exercise program for the duration of the study.
arm group label: Stair Climbing (SC)
criteria: 
gender: Female
minimum age: 58 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Pusan National University
investigator full name: Won-mok son
investigator title: postdoctoral fellow