<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/NCT04425057</url>
  </required_header>
  <id_info>
    <org_study_id>2012/0113</org_study_id>
    <nct_id>NCT04425057</nct_id>
  </id_info>
  <brief_title>Effect of a High Intensity Interval Training in Older Adults With Coronary Artery Disease</brief_title>
  <official_title>Effect of a High Intensity Interval Training in Older Adults With Coronary Artery Disease</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 study comparing 2 groups: interval training and control group. Interval training group will&#xD;
      perform a physiotherapy program based in exercises, at a high intensity, and stretching of&#xD;
      muscles at the end. Control group will not perform any physiotherapy program. Several&#xD;
      parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression,&#xD;
      functional capacity, blood pressure, lipid profile, physical activity, ecc.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A study comparing 2 groups: high intensity interval training and control group. Interval&#xD;
      training group will perform a two-month physiotherapy program based in exercises, at a high&#xD;
      intensity, and stretching of muscles at the end. Intensity will be established based on Borg&#xD;
      scale and an effort test.&#xD;
&#xD;
      Control group will not perform any physiotherapy program, but will have usual care with&#xD;
      medication.&#xD;
&#xD;
      Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression,&#xD;
      functional capacity, blood pressure, lipid profile, physical activity, ecc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>baseline</time_frame>
    <description>Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>2 months</time_frame>
    <description>Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>6 months</time_frame>
    <description>Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body mass index</measure>
    <time_frame>baseline</time_frame>
    <description>body mass index, m/kg2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body mass index</measure>
    <time_frame>2 months</time_frame>
    <description>body mass index, m/kg2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body mass index</measure>
    <time_frame>6 months</time_frame>
    <description>body mass index, m/kg2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>abdominal circumference</measure>
    <time_frame>baseline</time_frame>
    <description>abdominal circumference in cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>abdominal circumference</measure>
    <time_frame>2 months</time_frame>
    <description>abdominal circumference in cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>abdominal circumference</measure>
    <time_frame>6 months</time_frame>
    <description>abdominal circumference in cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body fat</measure>
    <time_frame>baseline</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT body fat in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body fat</measure>
    <time_frame>2 months</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT body fat in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body fat</measure>
    <time_frame>6 months</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT body fat in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visceral fat</measure>
    <time_frame>baseline</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT visceral fat in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visceral fat</measure>
    <time_frame>2 months</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT visceral fat in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visceral fat</measure>
    <time_frame>6 months</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT visceral fat in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>muscle mass</measure>
    <time_frame>baseline</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT muscle mass in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>muscle mass</measure>
    <time_frame>2 months</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT muscle mass in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>muscle mass</measure>
    <time_frame>6 months</time_frame>
    <description>Bioimpedanciometer OMRON HBF-500INT muscle mass in %</description>
  </primary_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>2 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>anxiety</measure>
    <time_frame>6 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>2 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>6 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>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. 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>2 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. 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>6 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. The score of the different types of activity is expressed in METS-minutes per week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional capacity</measure>
    <time_frame>baseline</time_frame>
    <description>Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time.&#xD;
Distance walked were determined on exercise cessation (meters).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional capacity</measure>
    <time_frame>2 months</time_frame>
    <description>Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time.&#xD;
Distance walked were determined on exercise cessation (meters).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional capacity</measure>
    <time_frame>6 months</time_frame>
    <description>Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time.&#xD;
Distance walked were determined on exercise cessation (meters).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>brachial systolic and diastolic blood pressure</measure>
    <time_frame>baseline</time_frame>
    <description>systolic and diastolic blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>brachial systolic and diastolic blood pressure</measure>
    <time_frame>2 months</time_frame>
    <description>systolic and diastolic blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>brachial systolic and diastolic blood pressure</measure>
    <time_frame>6 months</time_frame>
    <description>systolic and diastolic blood pressure (mmHg)</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>2 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>health related quality of life</measure>
    <time_frame>6 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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>Interval training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physiotherapy program during two months: Interval training at a high intensity, inlcuding a warm-up and a cool-down. Aerobic exercises, resistance exercises, stretching</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No physiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interval training</intervention_name>
    <arm_group_label>Interval training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed of coronary artery disease&#xD;
&#xD;
          -  Discharged from hospital, less than 2 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to move by themselves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</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>PhD, PT</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>
    <mesh_term>Heart Diseases</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/NCT04425057
org study id: 2012/0113
nct id: NCT04425057
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A study comparing 2 groups: interval training and control group. Interval training group will
      perform a physiotherapy program based in exercises, at a high intensity, and stretching of
      muscles at the end. Control group will not perform any physiotherapy program. Several
      parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression,
      functional capacity, blood pressure, lipid profile, physical activity, ecc.
A study comparing 2 groups: high intensity interval training and control group. Interval
      training group will perform a two-month physiotherapy program based in exercises, at a high
      intensity, and stretching of muscles at the end. Intensity will be established based on Borg
      scale and an effort test.

      Control group will not perform any physiotherapy program, but will have usual care with
      medication.

      Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression,
      functional capacity, blood pressure, lipid profile, physical activity, ecc.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Kinesiophobia
time frame: baseline
description: Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
measure: Kinesiophobia
time frame: 2 months
description: Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
measure: Kinesiophobia
time frame: 6 months
description: Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
measure: body mass index
time frame: baseline
description: body mass index, m/kg2
measure: body mass index
time frame: 2 months
description: body mass index, m/kg2
measure: body mass index
time frame: 6 months
description: body mass index, m/kg2
measure: abdominal circumference
time frame: baseline
description: abdominal circumference in cm
measure: abdominal circumference
time frame: 2 months
description: abdominal circumference in cm
measure: abdominal circumference
time frame: 6 months
description: abdominal circumference in cm
measure: body fat
time frame: baseline
description: Bioimpedanciometer OMRON HBF-500INT body fat in %
measure: body fat
time frame: 2 months
description: Bioimpedanciometer OMRON HBF-500INT body fat in %
measure: body fat
time frame: 6 months
description: Bioimpedanciometer OMRON HBF-500INT body fat in %
measure: visceral fat
time frame: baseline
description: Bioimpedanciometer OMRON HBF-500INT visceral fat in %
measure: visceral fat
time frame: 2 months
description: Bioimpedanciometer OMRON HBF-500INT visceral fat in %
measure: visceral fat
time frame: 6 months
description: Bioimpedanciometer OMRON HBF-500INT visceral fat in %
measure: muscle mass
time frame: baseline
description: Bioimpedanciometer OMRON HBF-500INT muscle mass in %
measure: muscle mass
time frame: 2 months
description: Bioimpedanciometer OMRON HBF-500INT muscle mass in %
measure: muscle mass
time frame: 6 months
description: Bioimpedanciometer OMRON HBF-500INT muscle mass in %
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: 2 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: anxiety
time frame: 6 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: 2 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: 6 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: 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: 2 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: physical activity
time frame: 6 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: functional capacity
time frame: baseline
description: Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time.
Distance walked were determined on exercise cessation (meters).
measure: functional capacity
time frame: 2 months
description: Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time.
Distance walked were determined on exercise cessation (meters).
measure: functional capacity
time frame: 6 months
description: Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time.
Distance walked were determined on exercise cessation (meters).
measure: brachial systolic and diastolic blood pressure
time frame: baseline
description: systolic and diastolic blood pressure (mmHg)
measure: brachial systolic and diastolic blood pressure
time frame: 2 months
description: systolic and diastolic blood pressure (mmHg)
measure: brachial systolic and diastolic blood pressure
time frame: 6 months
description: systolic and diastolic blood pressure (mmHg)
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: 2 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: health related quality of life
time frame: 6 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.
arm group label: Interval training
arm group type: Experimental
description: Physiotherapy program during two months: Interval training at a high intensity, inlcuding a warm-up and a cool-down. Aerobic exercises, resistance exercises, stretching
arm group label: Control group
arm group type: No Intervention
description: No physiotherapy
intervention type: Other
intervention name: Interval training
arm group label: Interval training
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Elena Marques-Sule
investigator title: PhD, PT
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Heart Diseases
sharing ipd: No