<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/NCT03796234</url>
  </required_header>
  <id_info>
    <org_study_id>147697976792</org_study_id>
    <nct_id>NCT03796234</nct_id>
  </id_info>
  <brief_title>Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease</brief_title>
  <official_title>Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease With Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</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>
      A multidisciplinary program based on physiotherapy and diet education will be carried out for&#xD;
      3 months in patients with coronary artery disease with percutaneous coronary intervention.&#xD;
      Educational lectures on nutrition and high intensity interval training will be developed in&#xD;
      old patients with chronic heart disease. A control group will not develop any program.&#xD;
      Effectiveness on anthropometric parameters, eating habits, physical activity, quality of&#xD;
      life, anxiety and depression will be assessed at baseline and at 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multidisciplinary program based on high intensity interval training and diet education will&#xD;
      be carried out for 3 months for patients with coronary artery disease with percutaneous&#xD;
      coronary intervention. Three educational lectures on nutrition and a 3-month high intensity&#xD;
      interval training will be developed in old patients with chronic heart disease. A control&#xD;
      group will not develop any program. Effectiveness on anthropometric parameters, eating&#xD;
      habits, physical activity, quality of life, anxiety and depression will be assessed at&#xD;
      baseline and at 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to the mediterranean diet</measure>
    <time_frame>baseline</time_frame>
    <description>Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to the mediterranean diet</measure>
    <time_frame>3 months</time_frame>
    <description>Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food consumption frequency questonnaire</measure>
    <time_frame>baseline</time_frame>
    <description>Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food consumption frequency questonnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %</measure>
    <time_frame>baseline</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %</measure>
    <time_frame>3 months</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight (in kilograms)</measure>
    <time_frame>baseline</time_frame>
    <description>Weight (in kilograms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight (in kilograms)</measure>
    <time_frame>3 months</time_frame>
    <description>Weight (in kilograms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>baseline</time_frame>
    <description>weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>3 months</time_frame>
    <description>weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm</measure>
    <time_frame>baseline</time_frame>
    <description>Circumferences by using a measuring tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm</measure>
    <time_frame>3 months</time_frame>
    <description>Circumferences by using a measuring tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triceps fat fold in mm</measure>
    <time_frame>Baseline</time_frame>
    <description>Lipocalibre Holtain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triceps fat fold in mm</measure>
    <time_frame>3 months</time_frame>
    <description>Lipocalibre Holtain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>baseline</time_frame>
    <description>International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.&#xD;
The score of the different types of activity is expressed in METS-minutes per week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>3 months</time_frame>
    <description>International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.&#xD;
The score of the different types of activity is expressed in METS-minutes per week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>baseline</time_frame>
    <description>Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status. It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health. The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health. The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100. A result of 100 indicates optimal health and 0 would reflect a very poor state of health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status. It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health. The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health. The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100. A result of 100 indicates optimal health and 0 would reflect a very poor state of health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>baseline</time_frame>
    <description>Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate &quot;case&quot; and greater than eight would be considered &quot;probable case&quot;. The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>3 months</time_frame>
    <description>Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate &quot;case&quot; and greater than eight would be considered &quot;probable case&quot;. The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>baseline</time_frame>
    <description>Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate &quot;case&quot; and greater than eight would be considered &quot;probable case&quot;. The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>3 months</time_frame>
    <description>Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate &quot;case&quot; and greater than eight would be considered &quot;probable case&quot;. The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Dietary and physiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A multidisciplinary program was developed. 3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary and physiotherapy</intervention_name>
    <description>3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.</description>
    <arm_group_label>Dietary and physiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.</description>
    <arm_group_label>Physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infarction or angina pectoris.&#xD;
&#xD;
          -  At least six months elapsed since the diagnosis of heart disease at the time of the&#xD;
             start of the study.&#xD;
&#xD;
          -  Be physically and cognitively able to complete the evaluations and the program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Present another type of cardiac disease different from ischemic heart disease.&#xD;
&#xD;
          -  Present any physical or psychiatric condition that prevents the normal performance of&#xD;
             the evaluations and the program.&#xD;
&#xD;
          -  Mobility problems to attend reassessments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Marques-Sule, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>September 15, 2020</last_update_submitted>
  <last_update_submitted_qc>September 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Elena Marques-Sule</investigator_full_name>
    <investigator_title>Doctor in Physiotherapy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <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/NCT03796234
org study id: 147697976792
nct id: NCT03796234
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A multidisciplinary program based on physiotherapy and diet education will be carried out for
      3 months in patients with coronary artery disease with percutaneous coronary intervention.
      Educational lectures on nutrition and high intensity interval training will be developed in
      old patients with chronic heart disease. A control group will not develop any program.
      Effectiveness on anthropometric parameters, eating habits, physical activity, quality of
      life, anxiety and depression will be assessed at baseline and at 3 months.
A multidisciplinary program based on high intensity interval training and diet education will
      be carried out for 3 months for patients with coronary artery disease with percutaneous
      coronary intervention. Three educational lectures on nutrition and a 3-month high intensity
      interval training will be developed in old patients with chronic heart disease. A control
      group will not develop any program. Effectiveness on anthropometric parameters, eating
      habits, physical activity, quality of life, anxiety and depression will be assessed at
      baseline and at 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Adherence to the mediterranean diet
time frame: baseline
description: Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).
measure: Adherence to the mediterranean diet
time frame: 3 months
description: Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).
measure: Food consumption frequency questonnaire
time frame: baseline
description: Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).
measure: Food consumption frequency questonnaire
time frame: 3 months
description: Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).
measure: Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
time frame: baseline
description: Bioimpedanciometer OMRON HBF-500INT
measure: Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
time frame: 3 months
description: Bioimpedanciometer OMRON HBF-500INT
measure: Weight (in kilograms)
time frame: baseline
description: Weight (in kilograms)
measure: Weight (in kilograms)
time frame: 3 months
description: Weight (in kilograms)
measure: Body mass index
time frame: baseline
description: weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
measure: Body mass index
time frame: 3 months
description: weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
measure: Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
time frame: baseline
description: Circumferences by using a measuring tape
measure: Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
time frame: 3 months
description: Circumferences by using a measuring tape
measure: Triceps fat fold in mm
time frame: Baseline
description: Lipocalibre Holtain
measure: Triceps fat fold in mm
time frame: 3 months
description: Lipocalibre Holtain
measure: Physical activity
time frame: baseline
description: International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.
The score of the different types of activity is expressed in METS-minutes per week.
measure: Physical activity
time frame: 3 months
description: International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.
The score of the different types of activity is expressed in METS-minutes per week.
measure: Health related quality of life
time frame: baseline
description: Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status. It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health. The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health. The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100. A result of 100 indicates optimal health and 0 would reflect a very poor state of health.
measure: Health related quality of life
time frame: 3 months
description: Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status. It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health. The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health. The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100. A result of 100 indicates optimal health and 0 would reflect a very poor state of health.
measure: Anxiety
time frame: baseline
description: Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
measure: Anxiety
time frame: 3 months
description: Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
measure: Depression
time frame: baseline
description: Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
measure: Depression
time frame: 3 months
description: Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
arm group label: Dietary and physiotherapy
arm group type: Experimental
description: A multidisciplinary program was developed. 3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
arm group label: Physiotherapy
arm group type: Experimental
description: A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
intervention type: Other
intervention name: Dietary and physiotherapy
description: 3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
arm group label: Dietary and physiotherapy
intervention type: Other
intervention name: Physiotherapy
description: A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
arm group label: Physiotherapy
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: No
last name: Elena Marques-Sule, PT, PhD
role: Principal Investigator
affiliation: University of Valencia
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Elena Marques-Sule
investigator title: Doctor in Physiotherapy
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No