<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/NCT03231631</url>
  </required_header>
  <id_info>
    <org_study_id>0001</org_study_id>
    <nct_id>NCT03231631</nct_id>
  </id_info>
  <brief_title>Efficacy Of An Education Plan And Adherence Follow-Up To The Exercise In Patients With Angioplasty And Stent Coronary</brief_title>
  <official_title>Efficacy Of An Education Plan And Adherence Follow-Up To The Exercise In Patients With Angioplasty And Implantation Of Coronary Stent, Measured With Hdl And Met In A Cardiac Rehabilitation Unit - Random Triple Blind Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clínica de Occidente S.A</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clínica de Occidente S.A</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Cardiovascular diseases are a leading cause of death worldwide. Some of the risk factors that&#xD;
      have been identified are considered as be non-modifiable and modifiable. Among the&#xD;
      non-modifiable, gender, age, race, family history and pathological antecedents such as&#xD;
      diabetes and hypertension among others are taken into account. The modifiable factors are&#xD;
      weight, abdominal circumference, habits such as smoking, alcohol consumption, diet and&#xD;
      especially the EXERCISE.&#xD;
&#xD;
      In order to modify these risk factors, patients are submitted to a strategy of health&#xD;
      promotion, disease prevention, pharmacological treatments, non-invasive and invasive&#xD;
      treatments such as cardiac catheterization, balloon coronary angioplasty and / or stent&#xD;
      implantation, cardiovascular surgeries etc. However, one of the most important strategies&#xD;
      that should be of great importance is to involve the patient and his family in these&#xD;
      treatments through education and follow-up strategies whether it is through the telephone,&#xD;
      home visit, e-mail, messages, etc. In this way, the patient is brought to a state of&#xD;
      self-determination and self-awareness that leads him to perform physical activity routinely&#xD;
      so he can change his cardiovascular risk factors and become a patient adherent to exercise or&#xD;
      any other treatment. This is where the importance of exercise or aerobic physical activity is&#xD;
      emphasized, as it is a low-cost activity that can be performed by any type of patient, and&#xD;
      that results are easily observed in physical and physiological changes that can be&#xD;
      objectively measurable, such as the levels in serum lipid profile (cholesterol,&#xD;
      triglycerides, LDL and HDL), or cardiovascular function tests such as stress tests with METs&#xD;
      indicating increased aerobic capacity (Improvement in ability to withstand a stress test).&#xD;
&#xD;
      Therefore, the purpose of this study is to submit a group of patients to an education and&#xD;
      telephone follow-up plan, emphasizing on the importance of performing physical activity with&#xD;
      the appropriate intensity and frequency so that they can include it within their daily&#xD;
      routine by itself and ensure &quot;the adherence to physical activity&quot;.&#xD;
&#xD;
      Physiological changes that these patients may present as a consequence of the acquired&#xD;
      routine physical activity by being subject to the education and telephone follow-up plan of&#xD;
      this research will be measured with serum HDL levels in a clinical laboratory test and MET in&#xD;
      a stress test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the population of the cardiac rehabilitation center of the Private IPS of Cali,&#xD;
      it will be analyzed by the program coordinator (Cardiac Rehabilitation Center) who are the&#xD;
      patients that finished the 36 sessions or finished their rehabilitation treatment scheme and&#xD;
      that will become potential candidates for the study.&#xD;
&#xD;
      If the patient is considered a candidate to enter the study, an interview will be made to&#xD;
      explain what the study is about and to verify whether or not he wishes to participate,&#xD;
      without indicating to which group he will belong (follow-up or control). If the patient&#xD;
      agrees to participate in the study, the process of signing the informed consent and the&#xD;
      application of the clinical trail where the basic patient information necessary for the study&#xD;
      entrance is collected.&#xD;
&#xD;
      Once the informed consent is signed, the patient is given a physical examination of his&#xD;
      clinical and physical condition (anthropometric parameters - exercise test) at the beginning&#xD;
      of the exercise, which consists of physical ergonomic tests (exercise test).&#xD;
&#xD;
      The test was performed from a symptom-limited ergometry in a treadmill stress test kit. The&#xD;
      Bruce protocol was used in the treadmill, which started after a warm-up period of three&#xD;
      minutes. During the test, continuous electrocardiographic monitoring and blood pressure&#xD;
      measurements were performed with a blood pressure monitor and heart rate monitor. The test&#xD;
      was terminated by the onset of fatigue, severe dyspnea, dizziness or when the patient reached&#xD;
      the highest heart rate expected for age, accompanied by the medical internist of the private&#xD;
      IPS program.&#xD;
&#xD;
      Additionally, a medical order is given with the respective recommendations (identifying that&#xD;
      the patient belongs to the study), for the collection of HDL blood in the clinical laboratory&#xD;
      hired for this purpose, in this way, the clinical laboratory does not perform authorization&#xD;
      requirements or that the patient has obstacles with HDL taking).&#xD;
&#xD;
      Allocation concealment: Once the physical tests and anthropometric parameters were completed&#xD;
      and the clinical survey was applied, the information was stored in a closed envelope and a&#xD;
      consecutive number was assigned according to the order of the exercise. The envelopes were&#xD;
      sent to the person responsible for the implementation of the tracking plan that according to&#xD;
      the order and the consecutive number will be added on the database.&#xD;
&#xD;
      The randomization of the groups is done in a pre-established template as follows: Simple&#xD;
      random sampling with Excel, a list is processed in the table of the study database and where&#xD;
      variables are collected, the numbering of anger from 1 to 80 according to the number of&#xD;
      patients required to enter the study, apply a simple randomization formula and a different&#xD;
      Excel spreadsheet, up to number 40 (the amount corresponding to the entire follow-up group&#xD;
      (group A) and control group B)), the numbers that have resulted from this randomization are&#xD;
      those assigned to the follow-up group.&#xD;
&#xD;
      In this way, when patients are registered in the database in the numerical order in the&#xD;
      envelope, it is automatically assigned according to the randomization of the group to which&#xD;
      the patient belongs (Follow-up or control).&#xD;
&#xD;
      After the patients are entered into the database of data collection and variables, the&#xD;
      patients belonging to the follow-up group (already marked according to previous&#xD;
      randomization) are separated and sent to the responsible nursing assistant with the purpose&#xD;
      of starting the established monitoring plan, such the activity must be registered in an Excel&#xD;
      table where the control and registration of the same will be carried out.&#xD;
&#xD;
      Once the nursing assistant responsible for the implementation of the follow-up plan will&#xD;
      proceed to carry out her activities as follows.&#xD;
&#xD;
      She will check the number of patients entering the study, check the date of entry and date of&#xD;
      completion, confirm that all patients have cellphone and land numbers where they can be&#xD;
      located, in addition to their residence address and email.&#xD;
&#xD;
      She will verify that the follow-up boxes for each patient are completed, which are performed&#xD;
      twice weekly for a total of 24 follow-ups or 12 weeks, duration of the follow-up plan.&#xD;
&#xD;
      She will start with phone calls, text messages and email according to the established&#xD;
      schedule in the work template or tracking log format.&#xD;
&#xD;
      In each follow-up box for each patient it will record the type of activity that performed,&#xD;
      call, text message or email where she sent the necessary recommendations for patients to&#xD;
      exercise.&#xD;
&#xD;
      Once the follow-up and the time are completed, the list of the patients who have completed&#xD;
      the data collection will be sent to the program to schedule the second studies in HDL and&#xD;
      Exercise TEST in The Center for Cardiac Rehabilitation.&#xD;
&#xD;
      An exercise adherence survey will be applied once the patient goes on week 6 or follow-up&#xD;
      number 12 in order to measure adherence to exercise by the patient. This result will be&#xD;
      processed in the tracking table, the applied surveys will be saved in a file other than&#xD;
      Excel.&#xD;
&#xD;
      Once the follow-up is completed, the patient will stop calling and the record will be handed&#xD;
      over to the person responsible for collecting data.&#xD;
&#xD;
      In the control group, according to the dates of entry to the study in week 6 related to the&#xD;
      order of admission, a survey of adherence to the exercise will be applied by an&#xD;
      administrative assistant who will keep a record of the same in a separate file and the&#xD;
      respective result.&#xD;
&#xD;
      As the 12-week study period ends, the cardiac rehabilitation nurse assistant will receive the&#xD;
      names of the patients and their respective phones from both the follow-up group and the&#xD;
      control group without having any group marking to which one they belong, so that the second&#xD;
      physical test or exercise test is performed and their respective order of clinical laboratory&#xD;
      HDL is given.&#xD;
&#xD;
      Through email, the laboratory will be requested to deliver physically and in a sealed&#xD;
      envelope all the results of tests performed to the patients that belong to the study. These&#xD;
      results will be delivered to the database manager and registry of variables.&#xD;
&#xD;
      All the documentation that as a result of the study, will be guarded by the person in charge&#xD;
      of the management of the database and registration of variables.&#xD;
&#xD;
      The person in charge of the database and registry of variables is the one who will inform the&#xD;
      moment in which the study has finished. Subsequently, the information will be organized and&#xD;
      the data will be given to the methodological adviser in order to organize, process and&#xD;
      analyze the statistical information as a result of it.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 29, 2019</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to exercise</measure>
    <time_frame>Measured at the end of the 12 week monitoring</time_frame>
    <description>Perform routine physical activity as a principle of self-determination and convert it into a healthy lifestyle or habit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HDL levels and MET</measure>
    <time_frame>Measured at baseline HDL and MET and at the end of the 12 week monitoring</time_frame>
    <description>Change in HDL level and MET as the difference between baseline HDL and MET and final HDL and MET</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Patient Adherence</condition>
  <arm_group>
    <arm_group_label>Education plan and adherence to exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational talk about the importance of nutrition and exercise as an important strategy to change cardiovascular risk factors at the start of the study.&#xD;
It will be sent via text, whatsapp, and / or e-mail on a weekly basis three text messages that remind them of the importance of doing the exercise and how often they should do it, it will be a predetermined text.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The blood sample will be taken for the collection of serum HDL and the aerobic capacity test measured in MET will be recorded at the beginning of the study.&#xD;
A survey will be conducted at week 12 of monitoring where adherence to exercise is measured during the 12-week study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education plan and adherence to exercise</intervention_name>
    <description>Send text messages with motivational sense at any time of the day, every 3 or 4 days.&#xD;
They will be given the option of performing directed exercise at the cardiac rehabilitation center.&#xD;
It will be recorded in an Excel table every time that text is sent to the patient.&#xD;
At the beginning and monthly, a brochure will be sent out explaining how physical activity is performed at home in case you can not walk.&#xD;
A monthly survey will be applied where the adherence to the exercise during the previous month is measured.&#xD;
These activities will be carried out for 12 weeks. At the end of week 12, patients will be referred to the cardiac rehabilitation unit in order to perform the aerobic capacity test again.</description>
    <arm_group_label>Education plan and adherence to exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postoperative subjects of angioplasty with implantation of coronary stent&#xD;
&#xD;
          -  Age between 35 and 65&#xD;
&#xD;
          -  Subjects with ability to perform the aerobic capacity test&#xD;
&#xD;
          -  Subjects culminating the cardiac rehabilitation program (3 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active phase of any acute disease&#xD;
&#xD;
          -  Poor adherence to the rehabilitation program (failure to comply with appointments or&#xD;
             with the recommendations given)&#xD;
&#xD;
          -  Patient with cardiovascular decompensation (unstable angina)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Ávila, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clínica de Occidente S.A</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Juan Carlos Avila</name>
      <address>
        <city>Cali</city>
        <state>Valle</state>
        <zip>32</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
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  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 1, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Education</keyword>
  <keyword>Stents</keyword>
  <keyword>Angioplasty</keyword>
  <keyword>Cardiac Rehabilitation</keyword>
  <keyword>Cholesterol, HDL</keyword>
  <keyword>Metabolic Equivalent</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03231631
org study id: 0001
nct id: NCT03231631
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cardiovascular diseases are a leading cause of death worldwide. Some of the risk factors that
      have been identified are considered as be non-modifiable and modifiable. Among the
      non-modifiable, gender, age, race, family history and pathological antecedents such as
      diabetes and hypertension among others are taken into account. The modifiable factors are
      weight, abdominal circumference, habits such as smoking, alcohol consumption, diet and
      especially the EXERCISE.

      In order to modify these risk factors, patients are submitted to a strategy of health
      promotion, disease prevention, pharmacological treatments, non-invasive and invasive
      treatments such as cardiac catheterization, balloon coronary angioplasty and / or stent
      implantation, cardiovascular surgeries etc. However, one of the most important strategies
      that should be of great importance is to involve the patient and his family in these
      treatments through education and follow-up strategies whether it is through the telephone,
      home visit, e-mail, messages, etc. In this way, the patient is brought to a state of
      self-determination and self-awareness that leads him to perform physical activity routinely
      so he can change his cardiovascular risk factors and become a patient adherent to exercise or
      any other treatment. This is where the importance of exercise or aerobic physical activity is
      emphasized, as it is a low-cost activity that can be performed by any type of patient, and
      that results are easily observed in physical and physiological changes that can be
      objectively measurable, such as the levels in serum lipid profile (cholesterol,
      triglycerides, LDL and HDL), or cardiovascular function tests such as stress tests with METs
      indicating increased aerobic capacity (Improvement in ability to withstand a stress test).

      Therefore, the purpose of this study is to submit a group of patients to an education and
      telephone follow-up plan, emphasizing on the importance of performing physical activity with
      the appropriate intensity and frequency so that they can include it within their daily
      routine by itself and ensure "the adherence to physical activity".

      Physiological changes that these patients may present as a consequence of the acquired
      routine physical activity by being subject to the education and telephone follow-up plan of
      this research will be measured with serum HDL levels in a clinical laboratory test and MET in
      a stress test.
According to the population of the cardiac rehabilitation center of the Private IPS of Cali,
      it will be analyzed by the program coordinator (Cardiac Rehabilitation Center) who are the
      patients that finished the 36 sessions or finished their rehabilitation treatment scheme and
      that will become potential candidates for the study.

      If the patient is considered a candidate to enter the study, an interview will be made to
      explain what the study is about and to verify whether or not he wishes to participate,
      without indicating to which group he will belong (follow-up or control). If the patient
      agrees to participate in the study, the process of signing the informed consent and the
      application of the clinical trail where the basic patient information necessary for the study
      entrance is collected.

      Once the informed consent is signed, the patient is given a physical examination of his
      clinical and physical condition (anthropometric parameters - exercise test) at the beginning
      of the exercise, which consists of physical ergonomic tests (exercise test).

      The test was performed from a symptom-limited ergometry in a treadmill stress test kit. The
      Bruce protocol was used in the treadmill, which started after a warm-up period of three
      minutes. During the test, continuous electrocardiographic monitoring and blood pressure
      measurements were performed with a blood pressure monitor and heart rate monitor. The test
      was terminated by the onset of fatigue, severe dyspnea, dizziness or when the patient reached
      the highest heart rate expected for age, accompanied by the medical internist of the private
      IPS program.

      Additionally, a medical order is given with the respective recommendations (identifying that
      the patient belongs to the study), for the collection of HDL blood in the clinical laboratory
      hired for this purpose, in this way, the clinical laboratory does not perform authorization
      requirements or that the patient has obstacles with HDL taking).

      Allocation concealment: Once the physical tests and anthropometric parameters were completed
      and the clinical survey was applied, the information was stored in a closed envelope and a
      consecutive number was assigned according to the order of the exercise. The envelopes were
      sent to the person responsible for the implementation of the tracking plan that according to
      the order and the consecutive number will be added on the database.

      The randomization of the groups is done in a pre-established template as follows: Simple
      random sampling with Excel, a list is processed in the table of the study database and where
      variables are collected, the numbering of anger from 1 to 80 according to the number of
      patients required to enter the study, apply a simple randomization formula and a different
      Excel spreadsheet, up to number 40 (the amount corresponding to the entire follow-up group
      (group A) and control group B)), the numbers that have resulted from this randomization are
      those assigned to the follow-up group.

      In this way, when patients are registered in the database in the numerical order in the
      envelope, it is automatically assigned according to the randomization of the group to which
      the patient belongs (Follow-up or control).

      After the patients are entered into the database of data collection and variables, the
      patients belonging to the follow-up group (already marked according to previous
      randomization) are separated and sent to the responsible nursing assistant with the purpose
      of starting the established monitoring plan, such the activity must be registered in an Excel
      table where the control and registration of the same will be carried out.

      Once the nursing assistant responsible for the implementation of the follow-up plan will
      proceed to carry out her activities as follows.

      She will check the number of patients entering the study, check the date of entry and date of
      completion, confirm that all patients have cellphone and land numbers where they can be
      located, in addition to their residence address and email.

      She will verify that the follow-up boxes for each patient are completed, which are performed
      twice weekly for a total of 24 follow-ups or 12 weeks, duration of the follow-up plan.

      She will start with phone calls, text messages and email according to the established
      schedule in the work template or tracking log format.

      In each follow-up box for each patient it will record the type of activity that performed,
      call, text message or email where she sent the necessary recommendations for patients to
      exercise.

      Once the follow-up and the time are completed, the list of the patients who have completed
      the data collection will be sent to the program to schedule the second studies in HDL and
      Exercise TEST in The Center for Cardiac Rehabilitation.

      An exercise adherence survey will be applied once the patient goes on week 6 or follow-up
      number 12 in order to measure adherence to exercise by the patient. This result will be
      processed in the tracking table, the applied surveys will be saved in a file other than
      Excel.

      Once the follow-up is completed, the patient will stop calling and the record will be handed
      over to the person responsible for collecting data.

      In the control group, according to the dates of entry to the study in week 6 related to the
      order of admission, a survey of adherence to the exercise will be applied by an
      administrative assistant who will keep a record of the same in a separate file and the
      respective result.

      As the 12-week study period ends, the cardiac rehabilitation nurse assistant will receive the
      names of the patients and their respective phones from both the follow-up group and the
      control group without having any group marking to which one they belong, so that the second
      physical test or exercise test is performed and their respective order of clinical laboratory
      HDL is given.

      Through email, the laboratory will be requested to deliver physically and in a sealed
      envelope all the results of tests performed to the patients that belong to the study. These
      results will be delivered to the database manager and registry of variables.

      All the documentation that as a result of the study, will be guarded by the person in charge
      of the management of the database and registration of variables.

      The person in charge of the database and registry of variables is the one who will inform the
      moment in which the study has finished. Subsequently, the information will be organized and
      the data will be given to the methodological adviser in order to organize, process and
      analyze the statistical information as a result of it.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Adherence to exercise
time frame: Measured at the end of the 12 week monitoring
description: Perform routine physical activity as a principle of self-determination and convert it into a healthy lifestyle or habit
measure: Change in HDL levels and MET
time frame: Measured at baseline HDL and MET and at the end of the 12 week monitoring
description: Change in HDL level and MET as the difference between baseline HDL and MET and final HDL and MET
arm group label: Education plan and adherence to exercise
arm group type: Experimental
description: Educational talk about the importance of nutrition and exercise as an important strategy to change cardiovascular risk factors at the start of the study.
It will be sent via text, whatsapp, and / or e-mail on a weekly basis three text messages that remind them of the importance of doing the exercise and how often they should do it, it will be a predetermined text.
arm group label: Control
arm group type: No Intervention
description: The blood sample will be taken for the collection of serum HDL and the aerobic capacity test measured in MET will be recorded at the beginning of the study.
A survey will be conducted at week 12 of monitoring where adherence to exercise is measured during the 12-week study.
intervention type: Behavioral
intervention name: Education plan and adherence to exercise
description: Send text messages with motivational sense at any time of the day, every 3 or 4 days.
They will be given the option of performing directed exercise at the cardiac rehabilitation center.
It will be recorded in an Excel table every time that text is sent to the patient.
At the beginning and monthly, a brochure will be sent out explaining how physical activity is performed at home in case you can not walk.
A monthly survey will be applied where the adherence to the exercise during the previous month is measured.
These activities will be carried out for 12 weeks. At the end of week 12, patients will be referred to the cardiac rehabilitation unit in order to perform the aerobic capacity test again.
arm group label: Education plan and adherence to exercise
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: No
last name: Juan Ávila, PT
role: Principal Investigator
affiliation: Clínica de Occidente S.A
facility: 
country: Colombia
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responsible party type: Sponsor
sharing ipd: No