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/NCT05991505</url>
    </required_header>
    <id_info>
      <org_study_id>5174</org_study_id>
      <nct_id>NCT05991505</nct_id>
    </id_info>
    <brief_title>Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women</brief_title>
    <official_title>Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Sao Paulo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Sao Paulo</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 objective of the present study was to verify the impact of physical exercise at a&#xD;
        distance (EFAD) on the level of mobility and quality of sleep of hypertensive elderly women.&#xD;
        To this end, hypertensive elderly women under drug treatment aged between 60 and 79 years old&#xD;
        age, without orthopedic limitations and/or cardiovascular complaints were assessed using&#xD;
        questionnaires, functional tests, sleep scale classification and use of actigraphy for 7&#xD;
        days. Afterwards, they were randomized into 2 groups, control and EFAD, with synchronous&#xD;
        training online 2x/week and by recorded class 1x/week. Reassessments were made after 10&#xD;
        weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Weight was checked using an OMRON model HBF-214 scale and height was checked using a 2-meter&#xD;
        Slim Fit compact stadiometer, after which the body mass index (BMI) was calculated. All&#xD;
        procedures took approximately 35 minutes, supervised by the researcher in charge. The&#xD;
        researcher used personal protective equipment, such as an N95 mask and frequent use of&#xD;
        alcohol gel on hands and surfaces. All participants and researchers involved in the study&#xD;
        were vaccinated against SARS COV-2 according to the health status of the study period.&#xD;
  &#xD;
        Physical tests were performed after measuring blood pressure (BP) with values equal to or&#xD;
        less than 160x100 mmHg. The Timed Up and Go (TUG) test was performed to assess the&#xD;
        participants' mobility and risk of falling. Studies show a greater risk of falling with times&#xD;
        above 20 seconds. After the TUG, the gait speed test was performed, as it is an important&#xD;
        predictor of cardiovascular health. In this test, a speed equal to or greater than 0.89&#xD;
        meters per second is expected in elderly people with preserved capacity.&#xD;
  &#xD;
        Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire .&#xD;
        There are 19 questions grouped into seven categories: subjective sleep quality; sleep&#xD;
        latency; nocturnal sleep duration; sleep effectiveness; sleep disorders; sleeping pills;&#xD;
        daytime sleepiness. Each category is scored from 0 to 3, allowing a total sum of 0 to 21.&#xD;
        Values above 9 in the total sum indicate poor sleep quality. This questionnaire is validated&#xD;
        and widely used. In addition to this questionnaire, the Epworth sleepiness scale was used,&#xD;
        containing 8 questions with scores from 0 to 3 points in each situation, with abnormal&#xD;
        sleepiness classification above 9 points.&#xD;
  &#xD;
        Subjects were also assessed for sleep quality with actigraphy. The ActTrust device, Condor&#xD;
        Instruments - Brazil was used. The device was placed on the participant's non-dominant wrist.&#xD;
        Participants' activities were monitored for a period of 7 days (24 hours), allowing for an&#xD;
        objective analysis of sleep quality. At the end of this period, a new home visit was carried&#xD;
        out to remove the actigraph and the information was transferred through a USB interface and&#xD;
        specific software that performed the data analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2021</start_date>
    <completion_date type="Actual">November 30, 2022</completion_date>
    <primary_completion_date type="Actual">November 30, 2022</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of sleep</measure>
      <time_frame>1</time_frame>
      <description>Quality of sleep evaluated by actigraphy and Pittsburgh Sleep Quality Index</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mobility</measure>
      <time_frame>2</time_frame>
      <description>Mobility evaluated by Timed up and Go Test and walking speed</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Aging Well</condition>
    <condition>Training Group, Sensitivity</condition>
    <arm_group>
      <arm_group_label>1- Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Volunteers with no physical activity during 10 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2 - Training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Volunteers with supervised home physical activity, twice a week, during 10 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical exercise</intervention_name>
      <description>Multimodal exercises twice a week</description>
      <arm_group_label>2 - Training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: hypertensive women in regular use of medication prescribed for high&#xD;
          blood pressure, physically active, and with basic knowledge to use smartphones, tablets,&#xD;
          with internet access and able to understand and answer the survey questionnaires.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:orthopedic limitations, cardiovascular complaints or limitation for&#xD;
          performing basic movements&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Julio C Moriguti, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Ribeirão Preto Medical School - USP</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Clinics Hospital, Ribeirão Preto Medical School, University of São Paulo</name>
        <address>
          <city>Ribeirão Preto</city>
          <state>São Paulo</state>
          <zip>14048900</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 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>University of Sao Paulo</investigator_affiliation>
      <investigator_full_name>Nereida Kilza da Costa Lima</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <!-- 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/NCT05991505
  org study id: 5174
  nct id: NCT05991505
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the present study was to verify the impact of physical exercise at a
        distance (EFAD) on the level of mobility and quality of sleep of hypertensive elderly women.
        To this end, hypertensive elderly women under drug treatment aged between 60 and 79 years old
        age, without orthopedic limitations and/or cardiovascular complaints were assessed using
        questionnaires, functional tests, sleep scale classification and use of actigraphy for 7
        days. Afterwards, they were randomized into 2 groups, control and EFAD, with synchronous
        training online 2x/week and by recorded class 1x/week. Reassessments were made after 10
        weeks.
  Weight was checked using an OMRON model HBF-214 scale and height was checked using a 2-meter
        Slim Fit compact stadiometer, after which the body mass index (BMI) was calculated. All
        procedures took approximately 35 minutes, supervised by the researcher in charge. The
        researcher used personal protective equipment, such as an N95 mask and frequent use of
        alcohol gel on hands and surfaces. All participants and researchers involved in the study
        were vaccinated against SARS COV-2 according to the health status of the study period.
  
        Physical tests were performed after measuring blood pressure (BP) with values equal to or
        less than 160x100 mmHg. The Timed Up and Go (TUG) test was performed to assess the
        participants' mobility and risk of falling. Studies show a greater risk of falling with times
        above 20 seconds. After the TUG, the gait speed test was performed, as it is an important
        predictor of cardiovascular health. In this test, a speed equal to or greater than 0.89
        meters per second is expected in elderly people with preserved capacity.
  
        Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire .
        There are 19 questions grouped into seven categories: subjective sleep quality; sleep
        latency; nocturnal sleep duration; sleep effectiveness; sleep disorders; sleeping pills;
        daytime sleepiness. Each category is scored from 0 to 3, allowing a total sum of 0 to 21.
        Values above 9 in the total sum indicate poor sleep quality. This questionnaire is validated
        and widely used. In addition to this questionnaire, the Epworth sleepiness scale was used,
        containing 8 questions with scores from 0 to 3 points in each situation, with abnormal
        sleepiness classification above 9 points.
  
        Subjects were also assessed for sleep quality with actigraphy. The ActTrust device, Condor
        Instruments - Brazil was used. The device was placed on the participant's non-dominant wrist.
        Participants' activities were monitored for a period of 7 days (24 hours), allowing for an
        objective analysis of sleep quality. At the end of this period, a new home visit was carried
        out to remove the actigraph and the information was transferred through a USB interface and
        specific software that performed the data analysis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Quality of sleep
  time frame: 1
  description: Quality of sleep evaluated by actigraphy and Pittsburgh Sleep Quality Index
  measure: Mobility
  time frame: 2
  description: Mobility evaluated by Timed up and Go Test and walking speed
  arm group label: 1- Control
  arm group type: No Intervention
  description: Volunteers with no physical activity during 10 weeks
  arm group label: 2 - Training
  arm group type: Active Comparator
  description: Volunteers with supervised home physical activity, twice a week, during 10 weeks
  intervention type: Other
  intervention name: Physical exercise
  description: Multimodal exercises twice a week
  arm group label: 2 - Training
  criteria: 
  gender: Female
  minimum age: 60 Years
  maximum age: 79 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Julio C Moriguti, MD, PhD
  role: Study Chair
  affiliation: Ribeirão Preto Medical School - USP
  facility: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: University of Sao Paulo
  investigator full name: Nereida Kilza da Costa Lima
  investigator title: MD, PhD
  mesh term: Hypersensitivity