<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/NCT02976506</url>
  </required_header>
  <id_info>
    <org_study_id>30847614.6.0000.5078</org_study_id>
    <nct_id>NCT02976506</nct_id>
  </id_info>
  <brief_title>Unsupervised Physical Activity in Elderly</brief_title>
  <official_title>Safety of an Unsupervised Physical Activity Program and Effects Over Blood Pressure, Physical Fitness and Quality of Life of Elderly Hypertensive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Goias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Goias</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over&#xD;
      blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study was approved by the Human and Animal Ethics Committee of the institution&#xD;
      and the participants were only randomized to participate after having signed the informed&#xD;
      consent form.&#xD;
&#xD;
      A population of elderly hypertensive patients registered at a reference center for&#xD;
      hypertension treatment was selected. The sample size was calculated considering a test power&#xD;
      of 80% with significance level of 5% and estimating a difference to be observed within the BP&#xD;
      values of 7 mmHg for systolic blood pressure (SBP) and 4 mmHg for diastolic blood pressure&#xD;
      (DBP). The sample calculated was 25 participants in each group being selected 20% more in&#xD;
      case of losses.&#xD;
&#xD;
      An electronic chart was created with numbers for the patients that were randomized into&#xD;
      control (CG) and intervention groups (IG).&#xD;
&#xD;
      The IG was included in an USPAP and the control group was kept under the usual care of the&#xD;
      service that includes orientation to perform PA according to the World Health Organization&#xD;
      recommendations.&#xD;
&#xD;
      Before the beginning of the protocol clinical and laboratorial data collected included:&#xD;
      weight, height, waist circumference, fasting glucose, hemoglobin A1C and lipid profile.&#xD;
&#xD;
      In addition to that health-related quality of life was assessed with the Short Form 36-item&#xD;
      Health Survey (SF-36). The SF-36 Questionnaire includes one multi-item scale that assesses&#xD;
      eight health concepts: 1) functional capacity; 2) physical aspects; 3) pain; 4) general&#xD;
      health status; 5) vitality; 6) social aspects; 7) emotional aspects; and 8) mental health.&#xD;
      The score of each health concept ranges from 0 to 100, in which zero means the worst general&#xD;
      health state and one hundred the best health state.&#xD;
&#xD;
      All patients underwent physical tests to evaluate their physical fitness: cardiorespiratory&#xD;
      fitness test (Cooper Test) and abdominal resistance test. Patients were classified according&#xD;
      to the Physical Aptitude Classification Tables for Users of Public Parks.&#xD;
&#xD;
      The BP was assessed with office BP measurements using OMRON - HEM 705 CP® semi-automatic&#xD;
      devices according to the VI Brazilian Hypertension Guidelines (BHG). Home blood pressure was&#xD;
      also performed following the same technics of office measurements and according to the III&#xD;
      Brazilian Guidelines of Home Blood Pressure Monitoring with 3 measurements in the morning&#xD;
      fasting and 3 at night before dinner in four consecutive days.&#xD;
&#xD;
      The physical activity prescriptions were individualized so that the patients would have no&#xD;
      doubts regarding execution when performing the exercise without the presence of the&#xD;
      prescribing professional. The prescribed physical activity was aerobic and walking was the&#xD;
      chosen one. The activity was prescribed in a planned, structured and repetitive way aiming to&#xD;
      maintain or improve one or more components of physical fitness. To achieve those goals&#xD;
      patients attended to 2 supervised sessions that took place in a one week period in&#xD;
      non-consecutive days. They were instructed to perform training at least 3 times a week during&#xD;
      30 minutes or more with a moderate intensity of 40 to 60% of their reserve heart rate which&#xD;
      mean walking slightly breathless but being able to pronounce complete phrases according to&#xD;
      the VI BHG recommendations. The total number of sessions prescribed was 36 throughout the 12&#xD;
      weeks. The minimum of 30 sessions was needed so the results could be validated.&#xD;
&#xD;
      Health educational strategies were used simultaneously to data collection to improve&#xD;
      adherence of both groups. Motivational actions were used specific for the IG. Weekly phone&#xD;
      calls were carried out to the IG in order to know about the number of sessions performed that&#xD;
      week, the duration of the practice and the total number of steps of each session. All&#xD;
      participants received a pedometer and a diary to register activities.&#xD;
&#xD;
      Safety was assessed considering: need to interrupt training due to lesions, falls,&#xD;
      incapacitating pain or acute events related to training that would require medical&#xD;
      assistance.&#xD;
&#xD;
      After 12 weeks all participants were reevaluated and all procedures were repeated to evaluate&#xD;
      the effects of the intervention.&#xD;
&#xD;
      Data collected was analyzed with software Statistical Package of Social Science, version&#xD;
      23.0, Chicago, USA. Qualitative variables were presented in absolute numbers and percentages&#xD;
      with the comparison between them being made with Qui Square Test or Exact Fisher Test.&#xD;
      Proportion comparison in the groups was performed applying Wilcoxon Test. Quantitative&#xD;
      variables were initially analyzed in terms of its distribution with Shapiro-Wilk test. Mean&#xD;
      variables comparison was performed with T-Student test for paired and unpaired samples. The&#xD;
      results were presented as mean values and standard deviation and p value &lt; 0,05 was&#xD;
      considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Lower Blood Pressure and or keeping it under control</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improve Cardiorespiratory fitness.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cooper Test (before and after the intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improve abdominal strength.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Abdominal resistance test before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>12 weeks</time_frame>
    <description>SF-36 questionnaire before and after the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Elderly</condition>
  <condition>Hypertension</condition>
  <condition>Physical Conditioning</condition>
  <arm_group>
    <arm_group_label>Unsupervised exercise program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To verify the interference of an unsupervised exercise program on blood pressure, physical fitness, quality of life and safety in elderly hypertensive patients. Participants were divided into the study group or control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical fitness and quality of life</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To verify the interference of a walking program on physical fitness and quality of life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Unsupervised exercise program</intervention_name>
    <description>Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to &lt; 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.</description>
    <arm_group_label>Unsupervised exercise program</arm_group_label>
    <other_name>interference on blood pressure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical fitness and quality of life</intervention_name>
    <description>Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to &lt; 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.</description>
    <arm_group_label>Physical fitness and quality of life</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion criteria were:&#xD;
&#xD;
          -  60 years old or more, stable BP on the last three months, no changes on&#xD;
             pharmacological treatment over the last six months and a sedentary behavior&#xD;
             (non-participation in any kind of physical activity for at least 2 months).&#xD;
&#xD;
        The exclusion criteria considered were:&#xD;
&#xD;
          -  uncontrolled diabetes&#xD;
&#xD;
          -  congestive heart failure&#xD;
&#xD;
          -  acute myocardial infarction in the last six months&#xD;
&#xD;
          -  stroke in the last six months or under rehabilitation&#xD;
&#xD;
          -  previously diagnosed chronic renal failure&#xD;
&#xD;
          -  acute infectious diseases&#xD;
&#xD;
          -  recent systemic or pulmonary embolism&#xD;
&#xD;
          -  pulmonary hypertension&#xD;
&#xD;
          -  BP higher than 159 x 99 mmHg&#xD;
&#xD;
          -  neuromuscular&#xD;
&#xD;
          -  musculoskeletal or articular disorders diagnosed and not treated&#xD;
&#xD;
          -  clinical evaluation restraining PA&#xD;
&#xD;
          -  any situation preventing the patient from walk. Those criteria were verified in&#xD;
             patients' medical charts.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hypertension League</name>
      <address>
        <city>Goiania</city>
        <state>Goias</state>
        <zip>74000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Goias</investigator_affiliation>
    <investigator_full_name>Patricia Silva Carneiro</investigator_full_name>
    <investigator_title>Principal Investigator</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>Undecided</sharing_ipd>
    <ipd_description>OPEN ACCESS</ipd_description>
  </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/NCT02976506
org study id: 30847614.6.0000.5078
nct id: NCT02976506
lead sponsor: 
has dmc: Yes
To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over
      blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive
      patients.
The present study was approved by the Human and Animal Ethics Committee of the institution
      and the participants were only randomized to participate after having signed the informed
      consent form.

      A population of elderly hypertensive patients registered at a reference center for
      hypertension treatment was selected. The sample size was calculated considering a test power
      of 80% with significance level of 5% and estimating a difference to be observed within the BP
      values of 7 mmHg for systolic blood pressure (SBP) and 4 mmHg for diastolic blood pressure
      (DBP). The sample calculated was 25 participants in each group being selected 20% more in
      case of losses.

      An electronic chart was created with numbers for the patients that were randomized into
      control (CG) and intervention groups (IG).

      The IG was included in an USPAP and the control group was kept under the usual care of the
      service that includes orientation to perform PA according to the World Health Organization
      recommendations.

      Before the beginning of the protocol clinical and laboratorial data collected included:
      weight, height, waist circumference, fasting glucose, hemoglobin A1C and lipid profile.

      In addition to that health-related quality of life was assessed with the Short Form 36-item
      Health Survey (SF-36). The SF-36 Questionnaire includes one multi-item scale that assesses
      eight health concepts: 1) functional capacity; 2) physical aspects; 3) pain; 4) general
      health status; 5) vitality; 6) social aspects; 7) emotional aspects; and 8) mental health.
      The score of each health concept ranges from 0 to 100, in which zero means the worst general
      health state and one hundred the best health state.

      All patients underwent physical tests to evaluate their physical fitness: cardiorespiratory
      fitness test (Cooper Test) and abdominal resistance test. Patients were classified according
      to the Physical Aptitude Classification Tables for Users of Public Parks.

      The BP was assessed with office BP measurements using OMRON - HEM 705 CP® semi-automatic
      devices according to the VI Brazilian Hypertension Guidelines (BHG). Home blood pressure was
      also performed following the same technics of office measurements and according to the III
      Brazilian Guidelines of Home Blood Pressure Monitoring with 3 measurements in the morning
      fasting and 3 at night before dinner in four consecutive days.

      The physical activity prescriptions were individualized so that the patients would have no
      doubts regarding execution when performing the exercise without the presence of the
      prescribing professional. The prescribed physical activity was aerobic and walking was the
      chosen one. The activity was prescribed in a planned, structured and repetitive way aiming to
      maintain or improve one or more components of physical fitness. To achieve those goals
      patients attended to 2 supervised sessions that took place in a one week period in
      non-consecutive days. They were instructed to perform training at least 3 times a week during
      30 minutes or more with a moderate intensity of 40 to 60% of their reserve heart rate which
      mean walking slightly breathless but being able to pronounce complete phrases according to
      the VI BHG recommendations. The total number of sessions prescribed was 36 throughout the 12
      weeks. The minimum of 30 sessions was needed so the results could be validated.

      Health educational strategies were used simultaneously to data collection to improve
      adherence of both groups. Motivational actions were used specific for the IG. Weekly phone
      calls were carried out to the IG in order to know about the number of sessions performed that
      week, the duration of the practice and the total number of steps of each session. All
      participants received a pedometer and a diary to register activities.

      Safety was assessed considering: need to interrupt training due to lesions, falls,
      incapacitating pain or acute events related to training that would require medical
      assistance.

      After 12 weeks all participants were reevaluated and all procedures were repeated to evaluate
      the effects of the intervention.

      Data collected was analyzed with software Statistical Package of Social Science, version
      23.0, Chicago, USA. Qualitative variables were presented in absolute numbers and percentages
      with the comparison between them being made with Qui Square Test or Exact Fisher Test.
      Proportion comparison in the groups was performed applying Wilcoxon Test. Quantitative
      variables were initially analyzed in terms of its distribution with Shapiro-Wilk test. Mean
      variables comparison was performed with T-Student test for paired and unpaired samples. The
      results were presented as mean values and standard deviation and p value < 0,05 was
      considered significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Lower Blood Pressure and or keeping it under control
time frame: 12 weeks
measure: Improve Cardiorespiratory fitness.
time frame: 12 weeks
description: Cooper Test (before and after the intervention).
measure: Improve abdominal strength.
time frame: 12 weeks
description: Abdominal resistance test before and after the intervention.
measure: Quality of life
time frame: 12 weeks
description: SF-36 questionnaire before and after the intervention
arm group label: Unsupervised exercise program
arm group type: Experimental
description: To verify the interference of an unsupervised exercise program on blood pressure, physical fitness, quality of life and safety in elderly hypertensive patients. Participants were divided into the study group or control group
arm group label: Physical fitness and quality of life
arm group type: Experimental
description: To verify the interference of a walking program on physical fitness and quality of life.
intervention type: Behavioral
intervention name: Unsupervised exercise program
description: Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to < 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.
arm group label: Unsupervised exercise program
other name: interference on blood pressure
intervention type: Behavioral
intervention name: Physical fitness and quality of life
description: Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to < 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.
arm group label: Physical fitness and quality of life
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Goias
investigator full name: Patricia Silva Carneiro
investigator title: Principal Investigator
mesh term: Hypertension
sharing ipd: Undecided
ipd description: OPEN ACCESS