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/NCT05987436</url>
    </required_header>
    <id_info>
      <org_study_id>HKara2</org_study_id>
      <nct_id>NCT05987436</nct_id>
    </id_info>
    <brief_title>Effect of Aerobic Exercise in Patients With Essential Hypertension</brief_title>
    <official_title>Effects of Supervised Versus Unsupervised Aerobic Exercise Training on Weight Loss, Functional Capacity, Quality of Life and Depression Level in Patients With Essential Hypertension</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>TC Erciyes University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>TC Erciyes 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 goal of this observational study is to evaluate the effects of a supervised aerobic&#xD;
        exercise training program on weight loss, functional capacity, quality of life (QoL), and&#xD;
        depression levels in patients with essential hypertension.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who chose the treatment type according to personal preferences were divided into two&#xD;
        groups: Group 1(n:91) exercised for six weeks, five sessions per week under the supervision&#xD;
        of a medical doctor in the aerobic exercise laboratory, and group 2(n:47) was advised to&#xD;
        maintain dietary habits and physical activity levels. Body weight, serum lipid levels,&#xD;
        functional capacity, QoL, and depression level of all the participants were evaluated at&#xD;
        baseline and 6 weeks later.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2017</start_date>
    <completion_date type="Actual">December 1, 2019</completion_date>
    <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Body weight</measure>
      <time_frame>was measured at the pre-treatment period and the post-treatment 6th week for all the participants by the same physician.</time_frame>
      <description>kilograms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood samples</measure>
      <time_frame>Twelve-hour fasting blood samples were collected between 6.00 am, and 10.00 am at baseline and week 6.</time_frame>
      <description>Serum total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, and triglycerides</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The functional capacity</measure>
      <time_frame>6MWT was assessed in face-to-face interviews before and immediately after the treatment was completed.</time_frame>
      <description>The 6MWT test and the estimated metabolic equivalents or METs were used performed to evaluate functional capacity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Life</measure>
      <time_frame>SF36 was assessed in face-to-face interviews before and immediately after the treatment was completed.</time_frame>
      <description>Quality of life was assessed with Short Form-36 (SF-36).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depression level</measure>
      <time_frame>BDI was assessed in face-to-face interviews before and immediately after the treatment was completed.</time_frame>
      <description>Depression level was assessed Beck Depression Inventory (BDI).</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">138</enrollment>
    <condition>Aerobic Exercise</condition>
    <condition>Essential Hypertension</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Group 1 exercised for six weeks, involving once per day, five sessions per week under the supervision of a medical doctor, and a nurse in the aerobic exercise laboratory. The aerobic exercise training program lasted six weeks, and patients lived in the hospital for the whole period. Aerobic exercise training was performed on cycle ergometers (Ergoline, ergoselect II 100/200/Reha, Germany) equipped with a computed ergometer and developed to monitor electrocardiography (ECG), heart rhythm, and BP. Each session consisted of a 5-minute warm-up, followed by 50 minutes of aerobic exercise with an intensity of 50% to 70% of heart rate reserve, calculated by Karvonen formula, and ended with a 5-min cool-down period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>The subjects assigned to the control group (Group 2) were advised to maintain dietary habits and physical activity levels and the aerobic exercise program was provided to them after completing the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Supervised Aerobic Exercise</intervention_name>
      <description>Group 1 exercised for six weeks, five sessions per week under the supervision of a medical doctor in the aerobic exercise laboratory.</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Essential Hypertension&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over 18 years of age,&#xD;
  &#xD;
            -  Absence of concomitant other metabolic and cardiovascular diseases.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having suffered an event of ischaemic heart disease (&lt;6 months),&#xD;
  &#xD;
            -  Secondary hypertension,&#xD;
  &#xD;
            -  Hypertrophic obstructive cardiomyopathy,&#xD;
  &#xD;
            -  Congestive heart failure,&#xD;
  &#xD;
            -  Uncontrolled cardiac arrhythmia,&#xD;
  &#xD;
            -  Thyroid dysfunction,&#xD;
  &#xD;
            -  Diabetes mellitus,&#xD;
  &#xD;
            -  Symptomatic peripheral arterial occlusive disease,&#xD;
  &#xD;
            -  Aortic insufficiency or stenosis,&#xD;
  &#xD;
            -  Pulmonary or heart disease with dyspnoea at small or moderate effort,&#xD;
  &#xD;
            -  An outbreak of orthopedic problems on hip, knee or ankles, such as arthroplasty,&#xD;
               contracture or severe osteoarthritis,&#xD;
  &#xD;
            -  Using of antidepressant or anxiolytic drugs,&#xD;
  &#xD;
            -  Pregnancy,&#xD;
  &#xD;
            -  Cognitive disfunction.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Selcuk University Faculty of Medicine</name>
        <address>
          <city>Konya</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>TC Erciyes University</investigator_affiliation>
      <investigator_full_name>Hasan Kara</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>supervised aerobic exercise</keyword>
    <keyword>functional capacity</keyword>
    <keyword>quality of life</keyword>
    <keyword>depression level</keyword>
    <keyword>essential hypertension</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Essential 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/NCT05987436
  org study id: HKara2
  nct id: NCT05987436
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to evaluate the effects of a supervised aerobic
        exercise training program on weight loss, functional capacity, quality of life (QoL), and
        depression levels in patients with essential hypertension.
  Patients who chose the treatment type according to personal preferences were divided into two
        groups: Group 1(n:91) exercised for six weeks, five sessions per week under the supervision
        of a medical doctor in the aerobic exercise laboratory, and group 2(n:47) was advised to
        maintain dietary habits and physical activity levels. Body weight, serum lipid levels,
        functional capacity, QoL, and depression level of all the participants were evaluated at
        baseline and 6 weeks later.
  observational model: Cohort
  time perspective: Prospective
  measure: Body weight
  time frame: was measured at the pre-treatment period and the post-treatment 6th week for all the participants by the same physician.
  description: kilograms
  measure: Blood samples
  time frame: Twelve-hour fasting blood samples were collected between 6.00 am, and 10.00 am at baseline and week 6.
  description: Serum total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, and triglycerides
  measure: The functional capacity
  time frame: 6MWT was assessed in face-to-face interviews before and immediately after the treatment was completed.
  description: The 6MWT test and the estimated metabolic equivalents or METs were used performed to evaluate functional capacity.
  measure: Quality of Life
  time frame: SF36 was assessed in face-to-face interviews before and immediately after the treatment was completed.
  description: Quality of life was assessed with Short Form-36 (SF-36).
  measure: Depression level
  time frame: BDI was assessed in face-to-face interviews before and immediately after the treatment was completed.
  description: Depression level was assessed Beck Depression Inventory (BDI).
  arm group label: Group 1
  description: Group 1 exercised for six weeks, involving once per day, five sessions per week under the supervision of a medical doctor, and a nurse in the aerobic exercise laboratory. The aerobic exercise training program lasted six weeks, and patients lived in the hospital for the whole period. Aerobic exercise training was performed on cycle ergometers (Ergoline, ergoselect II 100/200/Reha, Germany) equipped with a computed ergometer and developed to monitor electrocardiography (ECG), heart rhythm, and BP. Each session consisted of a 5-minute warm-up, followed by 50 minutes of aerobic exercise with an intensity of 50% to 70% of heart rate reserve, calculated by Karvonen formula, and ended with a 5-min cool-down period.
  arm group label: Group 2
  description: The subjects assigned to the control group (Group 2) were advised to maintain dietary habits and physical activity levels and the aerobic exercise program was provided to them after completing the study.
  intervention type: Other
  intervention name: Supervised Aerobic Exercise
  description: Group 1 exercised for six weeks, five sessions per week under the supervision of a medical doctor in the aerobic exercise laboratory.
  arm group label: Group 1
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: TC Erciyes University
  investigator full name: Hasan Kara
  investigator title: Medical Doctor
  mesh term: Hypertension
  mesh term: Essential Hypertension
  sharing ipd: No