<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/NCT03021044</url>
  </required_header>
  <id_info>
    <org_study_id>161098</org_study_id>
    <nct_id>NCT03021044</nct_id>
  </id_info>
  <brief_title>Physical Activity Intervention for Patients With Reduced Physical Performance After Acute Coronary Syndrome</brief_title>
  <acronym>HULK</acronym>
  <official_title>Physical Activity Intervention for Patients With Reduced Physical Performance After Acute Coronary Syndrome: a Randomized Clinical Trial (The HULK Pilot Study).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of Ferrara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital of Ferrara</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      RATIONALE AND OBJECTIVE OF THE STUDY&#xD;
&#xD;
      Patients with low functional capacity (frail patients) with cardiovascular disease, in&#xD;
      particular those undergoing invasive procedures or suffering from coronary artery disease,&#xD;
      have a much higher adverse events, death and re-hospitalizations. and complications,&#xD;
      suggesting the need for a more accurate functional stratification and a more careful&#xD;
      evaluation of the risk/benefit ratio of some invasive procedures. An early and ad hoc&#xD;
      physical activity intervention could be improve functional autonomy of these patients early&#xD;
      after discharge with benefit on long-term outcome. The present study is performed to assess&#xD;
      the impact, evaluated by Short Physical Performance Battery (SPPB), of a program of physical&#xD;
      activity early after discharge in elderly patients aged 75 years and older with low physical&#xD;
      performance.&#xD;
&#xD;
      This is an interventional, multicenter, prospective, randomized, phase III study. The present&#xD;
      study is expected to enroll elderly patients admitted to hospital for acute coronary syndrome&#xD;
      undergoing percutaneous coronary angioplasty and stratified with SPPB score predischarge. At&#xD;
      the moment of discharge there will be a screening: patients with SPPB score 0-2 o 10-12 will&#xD;
      be exclusively followed up by clinical visit every year. Patients with SPPB score 3-9 will be&#xD;
      evaluated during the inclusion visit when SPPB will be repeated. If SPPB score will be 0-3 or&#xD;
      10-12, patients will be considered screening failure and will be followed up by clinical&#xD;
      visit; patients with SPPB score between 4 to 9 will be randomized to standard of care (see&#xD;
      below) or to an ad hoc physical activity program (see below). The aim of the study is to&#xD;
      demonstrate 6 months later an improvement in the SPPB score (at least 1 point) in patients&#xD;
      randomized to physical activity intervention versus patients randomized to standard of care.&#xD;
      All patients will be evaluated until 3 years after randomization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND Physical activity helps to prevent stroke, type II diabetes mellitus and coronary&#xD;
      artery disease, while physical inactivity has been linked to declines in both muscle strength&#xD;
      and cardiovascular function. Despite the evidence of the benefits of physical activity are&#xD;
      well known, 61% of adults over the age of 65 are not meeting the recommended levels of&#xD;
      physical activity. It has been demonstrated that regular physical exercise benefits in&#xD;
      primary and secondary prevention in patients with cardiovascular diseases and improves&#xD;
      functional capacity. The incidence of cardiovascular disease is higher in older patients&#xD;
      (especially over 75 years old). In Italy, life expectancy at birth has reached 80 years in&#xD;
      men and 85 in women; in about 50 years, life expectancy at the age of 80 has increased by an&#xD;
      extraordinary 61% and 55%, respectively, due to more effective therapies and lower mortality&#xD;
      of many diseases. So, as recommended by guidelines, physical activity should be suggested to&#xD;
      older coronary patients; some studies demonstrated the benefit of physical training also in&#xD;
      older patients, but only few studies enrolled patients aged 65 years and over because of some&#xD;
      difficulties about patients' compliance mainly due to logistic problems and lack of&#xD;
      motivation by doctors. As far as we know no studies have evaluated impact of physical&#xD;
      activity intervention on functional capacity of older patients admitted to hospital for acute&#xD;
      coronary syndrome. Among the numerous tests proposed in the literature for the functional&#xD;
      evaluation and objective measures of physical capability in elderly patient, the Short&#xD;
      Physical Performance Battery (SPPB) and the evaluation of hand grip strength (grip strength)&#xD;
      are those characterized by an improved prognostic ability and an easy administration.&#xD;
&#xD;
      RATIONALE AND OBJECTIVE OF THE STUDY Patients with low functional capacity (frail patients)&#xD;
      with cardiovascular disease, in particular those undergoing invasive procedures or suffering&#xD;
      from coronary artery disease, have a much higher adverse events, death and&#xD;
      re-hospitalizations. and complications, suggesting the need for a more accurate functional&#xD;
      stratification and a more careful evaluation of the risk/benefit ratio of some invasive&#xD;
      procedures. An early and ad hoc physical activity intervention could be improve functional&#xD;
      autonomy of these patients early after discharge with benefit on long-term outcome. The&#xD;
      present study is performed to assess the impact, evaluated by Short Physical Performance&#xD;
      Battery (SPPB), of a program of physical activity early after discharge in elderly patients&#xD;
      aged 75 years and older with low physical performance.&#xD;
&#xD;
      STUDY DESIGN This is an interventional, multicenter, prospective, randomized, phase III&#xD;
      study. The present study is expected to enroll elderly patients admitted to hospital for&#xD;
      acute coronary syndrome undergoing percutaneous coronary angioplasty and stratified with SPPB&#xD;
      score predischarge. At the moment of discharge there will be a screening: patients with SPPB&#xD;
      score 0-2 o 10-12 will be exclusively followed up by clinical visit every year. Patients with&#xD;
      SPPB score 3-9 will be evaluated during the inclusion visit when SPPB will be repeated. If&#xD;
      SPPB score will be 0-3 or 10-12, patients will be considered screening failure and will be&#xD;
      followed up by clinical visit; patients with SPPB score between 4 to 9 will be randomized to&#xD;
      standard of care (see below) or to an ad hoc physical activity program (see below). The aim&#xD;
      of the study is to demonstrate 6 months later an improvement in the SPPB score (at least 1&#xD;
      point) in patients randomized to physical activity intervention versus patients randomized to&#xD;
      standard of care. All patients will be evaluated until 3 years after randomization.&#xD;
&#xD;
      RANDOMIZATION&#xD;
&#xD;
      At discharge an investigator doctor and a study coordinator show to patients the study&#xD;
      protocol, aims, risks and benefit. If the patient accepts to participate to the study, he&#xD;
      signs the informed consent and he will be evaluated with SPPB score and other tests in the&#xD;
      screening evaluation (T0). Patients with SPPB score &lt;3 or &gt;9 will be excluded and will be&#xD;
      followed up with exclusively clinical visit every year. Patients with SPPB score 4-9 will be&#xD;
      enrolled and data will be collected in the study case report form. These patients will be&#xD;
      re-evaluated in the inclusion visit 30 days later (T1); if SPPB score will be 0-3 or 10-12&#xD;
      the patients will be considered screening failure and they will be followed up exclusively&#xD;
      with clinical visit every year; on the contrary, if SPPB score will be 4-9, patients will be&#xD;
      randomized to standard of care group or experimental group. There will be a stratified&#xD;
      randomization by:&#xD;
&#xD;
        -  male vs. female&#xD;
&#xD;
        -  SPPB value 4-6 vs. SPPB value 7-9&#xD;
&#xD;
        -  admission for ST-segment elevation myocardial infarction vs. non ST-segment elevation&#xD;
           acute coronary syndrome&#xD;
&#xD;
      DESCRIPTION OF THE STUDY GROUPS&#xD;
&#xD;
        -  STANDARD OF CARE GROUP The standard of care group will be recommended about medications&#xD;
           and a correct life style (physical activity, low salt and low fat diet, no smoking) in&#xD;
           order to prevent cardiovascular events. In this 15-minutes talk study doctor will&#xD;
           explain to patients and relatives the importance of aerobic physical activity (30-60&#xD;
           minutes daily, moderate intensity, for example speedy walking, for at least 5&#xD;
           days/weekly) with the aim of reducing cardiovascular risk. Patients will also receive a&#xD;
           brochure with clear explanations. Study doctor and study coordinator will be helpful for&#xD;
           any question and they will ensure that patients and relatives understand the importance&#xD;
           of physical activity for cardiovascular health.&#xD;
&#xD;
        -  EXPERIMENTAL GROUP, PHYSICAL ACTIVITY INTERVENTION Besides standard of care, the&#xD;
           experimental group will participate to a program of physical activity intervention.&#xD;
           Following hospital discharge, participants in stable clinical conditions will be&#xD;
           referred by their cardiologist to the exercise-based secondary prevention program in&#xD;
           dedicated centers. All patients should report no difficulty climbing one flight of&#xD;
           stairs without resting or performing basic activities of daily living. The ultimate goal&#xD;
           of the program is long-term promotion and maintenance of a physically active lifestyle&#xD;
           in order to improve cardiorespiratory fitness and functional ability. Patients will be&#xD;
           treated for cardiovascular and other diseases according to accepted international&#xD;
           guidelines. All exercise testing and training sessions will be performed without&#xD;
           discontinuing the prescribed medications. On admission to the program, and quarterly&#xD;
           during follow-up, each patient will perform a 1-km treadmill walk test as previously&#xD;
           described. Briefly, the test will be carried out as follows: the participants will be&#xD;
           instructed to select a pace that they could maintain for 10 to 30 min at a moderate&#xD;
           perceived exercise intensity using the Borg 6-20 scale. Participants will start the test&#xD;
           walking on the level at 2.0 km/h, with subsequent increases of 0.3 km/h every 30 s up to&#xD;
           a walking speed corresponding to a perceived exertion of 11-13 on the Borg scale. The&#xD;
           test will be then started and the rate of perceived exertion acquired every 2 min.&#xD;
           Walking speed will be adjusted to maintain the selected moderate perceived intensity.&#xD;
           Heart rate will be monitored continuously during the test. Blood pressure will be&#xD;
           monitored at least before and immediately after the test. No individual will be excluded&#xD;
           on the basis of his/her performance on the treadmill protocol. Subjects walking at a&#xD;
           perceived moderate speed &lt; 3.0 km/h will perform the test over the distance of 500-m.&#xD;
           The time to complete either 500-m and 1-km will be recorded and averaged walking speed&#xD;
           calculated accordingly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">April 28, 2021</completion_date>
  <primary_completion_date type="Actual">October 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical performance</measure>
    <time_frame>6 months</time_frame>
    <description>result of the short physical performance battery test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical performance</measure>
    <time_frame>1 year</time_frame>
    <description>result of the short physical performance battery test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical performance</measure>
    <time_frame>2 years</time_frame>
    <description>result of the short physical performance battery test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical performance</measure>
    <time_frame>3 years</time_frame>
    <description>result of the short physical performance battery test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>cumulative occurrence of all-cause mortality and all-cause hospital readmission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical adverse events</measure>
    <time_frame>2 years</time_frame>
    <description>cumulative occurrence of all-cause mortality and all-cause hospital readmission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical adverse events</measure>
    <time_frame>3 years</time_frame>
    <description>cumulative occurrence of all-cause mortality and all-cause hospital readmission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac adverse events</measure>
    <time_frame>2 years</time_frame>
    <description>cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac adverse events</measure>
    <time_frame>3 years</time_frame>
    <description>cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause</description>
  </secondary_outcome>
  <other_outcome>
    <measure>compliance to antiplatelet agents</measure>
    <time_frame>1 year</time_frame>
    <description>percentage of patients maintaining dual antiplatelet regimen</description>
  </other_outcome>
  <other_outcome>
    <measure>physical training and session side effects</measure>
    <time_frame>6 months</time_frame>
    <description>cumulative occurrence of any complications or adverse events during the physical activity training and session</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>STANDARD OF CARE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The standard of care group will be recommended about medications and a correct life style (physical activity, low salt and low fat diet, no smoking) in order to prevent cardiovascular events. In this 15-minutes talk study doctor will explain to patients and relatives the importance of aerobic physical activity (30-60 minutes daily, moderate intensity, for example speedy walking, for at least 5 days/weekly) with the aim of reducing cardiovascular risk. Patients will also receive a brochure with clear explanations. Study doctor and study coordinator will be helpful for any question and they will ensure that patients and relatives understand the importance of physical activity for cardiovascular health.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PHYSICAL ACTIVITY INTERVENTION</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Besides standard of care, the experimental group will participate to a program of physical activity intervention. Following hospital discharge, participants in stable clinical conditions will be referred by their cardiologist to the exercise-based secondary prevention program. All exercise testing and training sessions will be performed without discontinuing the prescribed medications. On admission to the program, and quarterly during follow-up, each patient will perform a 1-km treadmill walk test as previously described (1k-TWT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physical activity intervention</intervention_name>
    <description>30, 60, 90 and 120 days after hospital discharge a clinical visit and session of physical activity training and program</description>
    <arm_group_label>PHYSICAL ACTIVITY INTERVENTION</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard of care</intervention_name>
    <description>30, 60, 90 and 120 days after hospital discharge a clinical visit with correct style life recommendation</description>
    <arm_group_label>STANDARD OF CARE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  age ≥70 years old&#xD;
&#xD;
          -  hospital admission for acute coronary syndrome&#xD;
&#xD;
          -  coronary artery angiography and successfully percutaneous coronary revascularization&#xD;
&#xD;
          -  result of the short physical performance battery test at the inclusion visit between 4&#xD;
             and 9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic heart failure (new york heart association classification III-IV)&#xD;
&#xD;
          -  left ventricle ejection fraction &lt;30%.&#xD;
&#xD;
          -  severe aortic or mitral valvulopathy&#xD;
&#xD;
          -  three vessel coronary artery disease or left main coronary artery disease requiring&#xD;
             surgical coronary revascularization&#xD;
&#xD;
          -  need of staged percutaneous coronary intervention&#xD;
&#xD;
          -  severe cognitive impairment (defined as short portable mental status questionnaire &lt;&#xD;
             4)&#xD;
&#xD;
          -  physical limitation/impairment not permitting physical activity training annd program&#xD;
&#xD;
          -  life expectancy &lt;12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Ferrara</name>
      <address>
        <city>Cona</city>
        <state>Ferrara</state>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Guglielmo da Saliceto</name>
      <address>
        <city>Piacenza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa maria delle Croci</name>
      <address>
        <city>Ravenna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital of Ferrara</investigator_affiliation>
    <investigator_full_name>Gianluca Campo</investigator_full_name>
    <investigator_title>Interventional cardiologist and Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03021044
org study id: 161098
nct id: NCT03021044
lead sponsor: 
has dmc: Yes
RATIONALE AND OBJECTIVE OF THE STUDY

      Patients with low functional capacity (frail patients) with cardiovascular disease, in
      particular those undergoing invasive procedures or suffering from coronary artery disease,
      have a much higher adverse events, death and re-hospitalizations. and complications,
      suggesting the need for a more accurate functional stratification and a more careful
      evaluation of the risk/benefit ratio of some invasive procedures. An early and ad hoc
      physical activity intervention could be improve functional autonomy of these patients early
      after discharge with benefit on long-term outcome. The present study is performed to assess
      the impact, evaluated by Short Physical Performance Battery (SPPB), of a program of physical
      activity early after discharge in elderly patients aged 75 years and older with low physical
      performance.

      This is an interventional, multicenter, prospective, randomized, phase III study. The present
      study is expected to enroll elderly patients admitted to hospital for acute coronary syndrome
      undergoing percutaneous coronary angioplasty and stratified with SPPB score predischarge. At
      the moment of discharge there will be a screening: patients with SPPB score 0-2 o 10-12 will
      be exclusively followed up by clinical visit every year. Patients with SPPB score 3-9 will be
      evaluated during the inclusion visit when SPPB will be repeated. If SPPB score will be 0-3 or
      10-12, patients will be considered screening failure and will be followed up by clinical
      visit; patients with SPPB score between 4 to 9 will be randomized to standard of care (see
      below) or to an ad hoc physical activity program (see below). The aim of the study is to
      demonstrate 6 months later an improvement in the SPPB score (at least 1 point) in patients
      randomized to physical activity intervention versus patients randomized to standard of care.
      All patients will be evaluated until 3 years after randomization.
BACKGROUND Physical activity helps to prevent stroke, type II diabetes mellitus and coronary
      artery disease, while physical inactivity has been linked to declines in both muscle strength
      and cardiovascular function. Despite the evidence of the benefits of physical activity are
      well known, 61% of adults over the age of 65 are not meeting the recommended levels of
      physical activity. It has been demonstrated that regular physical exercise benefits in
      primary and secondary prevention in patients with cardiovascular diseases and improves
      functional capacity. The incidence of cardiovascular disease is higher in older patients
      (especially over 75 years old). In Italy, life expectancy at birth has reached 80 years in
      men and 85 in women; in about 50 years, life expectancy at the age of 80 has increased by an
      extraordinary 61% and 55%, respectively, due to more effective therapies and lower mortality
      of many diseases. So, as recommended by guidelines, physical activity should be suggested to
      older coronary patients; some studies demonstrated the benefit of physical training also in
      older patients, but only few studies enrolled patients aged 65 years and over because of some
      difficulties about patients' compliance mainly due to logistic problems and lack of
      motivation by doctors. As far as we know no studies have evaluated impact of physical
      activity intervention on functional capacity of older patients admitted to hospital for acute
      coronary syndrome. Among the numerous tests proposed in the literature for the functional
      evaluation and objective measures of physical capability in elderly patient, the Short
      Physical Performance Battery (SPPB) and the evaluation of hand grip strength (grip strength)
      are those characterized by an improved prognostic ability and an easy administration.

      RATIONALE AND OBJECTIVE OF THE STUDY Patients with low functional capacity (frail patients)
      with cardiovascular disease, in particular those undergoing invasive procedures or suffering
      from coronary artery disease, have a much higher adverse events, death and
      re-hospitalizations. and complications, suggesting the need for a more accurate functional
      stratification and a more careful evaluation of the risk/benefit ratio of some invasive
      procedures. An early and ad hoc physical activity intervention could be improve functional
      autonomy of these patients early after discharge with benefit on long-term outcome. The
      present study is performed to assess the impact, evaluated by Short Physical Performance
      Battery (SPPB), of a program of physical activity early after discharge in elderly patients
      aged 75 years and older with low physical performance.

      STUDY DESIGN This is an interventional, multicenter, prospective, randomized, phase III
      study. The present study is expected to enroll elderly patients admitted to hospital for
      acute coronary syndrome undergoing percutaneous coronary angioplasty and stratified with SPPB
      score predischarge. At the moment of discharge there will be a screening: patients with SPPB
      score 0-2 o 10-12 will be exclusively followed up by clinical visit every year. Patients with
      SPPB score 3-9 will be evaluated during the inclusion visit when SPPB will be repeated. If
      SPPB score will be 0-3 or 10-12, patients will be considered screening failure and will be
      followed up by clinical visit; patients with SPPB score between 4 to 9 will be randomized to
      standard of care (see below) or to an ad hoc physical activity program (see below). The aim
      of the study is to demonstrate 6 months later an improvement in the SPPB score (at least 1
      point) in patients randomized to physical activity intervention versus patients randomized to
      standard of care. All patients will be evaluated until 3 years after randomization.

      RANDOMIZATION

      At discharge an investigator doctor and a study coordinator show to patients the study
      protocol, aims, risks and benefit. If the patient accepts to participate to the study, he
      signs the informed consent and he will be evaluated with SPPB score and other tests in the
      screening evaluation (T0). Patients with SPPB score <3 or >9 will be excluded and will be
      followed up with exclusively clinical visit every year. Patients with SPPB score 4-9 will be
      enrolled and data will be collected in the study case report form. These patients will be
      re-evaluated in the inclusion visit 30 days later (T1); if SPPB score will be 0-3 or 10-12
      the patients will be considered screening failure and they will be followed up exclusively
      with clinical visit every year; on the contrary, if SPPB score will be 4-9, patients will be
      randomized to standard of care group or experimental group. There will be a stratified
      randomization by:

        -  male vs. female

        -  SPPB value 4-6 vs. SPPB value 7-9

        -  admission for ST-segment elevation myocardial infarction vs. non ST-segment elevation
           acute coronary syndrome

      DESCRIPTION OF THE STUDY GROUPS

        -  STANDARD OF CARE GROUP The standard of care group will be recommended about medications
           and a correct life style (physical activity, low salt and low fat diet, no smoking) in
           order to prevent cardiovascular events. In this 15-minutes talk study doctor will
           explain to patients and relatives the importance of aerobic physical activity (30-60
           minutes daily, moderate intensity, for example speedy walking, for at least 5
           days/weekly) with the aim of reducing cardiovascular risk. Patients will also receive a
           brochure with clear explanations. Study doctor and study coordinator will be helpful for
           any question and they will ensure that patients and relatives understand the importance
           of physical activity for cardiovascular health.

        -  EXPERIMENTAL GROUP, PHYSICAL ACTIVITY INTERVENTION Besides standard of care, the
           experimental group will participate to a program of physical activity intervention.
           Following hospital discharge, participants in stable clinical conditions will be
           referred by their cardiologist to the exercise-based secondary prevention program in
           dedicated centers. All patients should report no difficulty climbing one flight of
           stairs without resting or performing basic activities of daily living. The ultimate goal
           of the program is long-term promotion and maintenance of a physically active lifestyle
           in order to improve cardiorespiratory fitness and functional ability. Patients will be
           treated for cardiovascular and other diseases according to accepted international
           guidelines. All exercise testing and training sessions will be performed without
           discontinuing the prescribed medications. On admission to the program, and quarterly
           during follow-up, each patient will perform a 1-km treadmill walk test as previously
           described. Briefly, the test will be carried out as follows: the participants will be
           instructed to select a pace that they could maintain for 10 to 30 min at a moderate
           perceived exercise intensity using the Borg 6-20 scale. Participants will start the test
           walking on the level at 2.0 km/h, with subsequent increases of 0.3 km/h every 30 s up to
           a walking speed corresponding to a perceived exertion of 11-13 on the Borg scale. The
           test will be then started and the rate of perceived exertion acquired every 2 min.
           Walking speed will be adjusted to maintain the selected moderate perceived intensity.
           Heart rate will be monitored continuously during the test. Blood pressure will be
           monitored at least before and immediately after the test. No individual will be excluded
           on the basis of his/her performance on the treadmill protocol. Subjects walking at a
           perceived moderate speed < 3.0 km/h will perform the test over the distance of 500-m.
           The time to complete either 500-m and 1-km will be recorded and averaged walking speed
           calculated accordingly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Physical performance
time frame: 6 months
description: result of the short physical performance battery test
measure: Physical performance
time frame: 1 year
description: result of the short physical performance battery test
measure: Physical performance
time frame: 2 years
description: result of the short physical performance battery test
measure: Physical performance
time frame: 3 years
description: result of the short physical performance battery test
measure: clinical adverse events
time frame: 1 year
description: cumulative occurrence of all-cause mortality and all-cause hospital readmission
measure: clinical adverse events
time frame: 2 years
description: cumulative occurrence of all-cause mortality and all-cause hospital readmission
measure: clinical adverse events
time frame: 3 years
description: cumulative occurrence of all-cause mortality and all-cause hospital readmission
measure: cardiac adverse events
time frame: 1 year
description: cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause
measure: cardiac adverse events
time frame: 2 years
description: cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause
measure: cardiac adverse events
time frame: 3 years
description: cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause
measure: compliance to antiplatelet agents
time frame: 1 year
description: percentage of patients maintaining dual antiplatelet regimen
measure: physical training and session side effects
time frame: 6 months
description: cumulative occurrence of any complications or adverse events during the physical activity training and session
arm group label: STANDARD OF CARE
arm group type: Other
description: The standard of care group will be recommended about medications and a correct life style (physical activity, low salt and low fat diet, no smoking) in order to prevent cardiovascular events. In this 15-minutes talk study doctor will explain to patients and relatives the importance of aerobic physical activity (30-60 minutes daily, moderate intensity, for example speedy walking, for at least 5 days/weekly) with the aim of reducing cardiovascular risk. Patients will also receive a brochure with clear explanations. Study doctor and study coordinator will be helpful for any question and they will ensure that patients and relatives understand the importance of physical activity for cardiovascular health.
arm group label: PHYSICAL ACTIVITY INTERVENTION
arm group type: Experimental
description: Besides standard of care, the experimental group will participate to a program of physical activity intervention. Following hospital discharge, participants in stable clinical conditions will be referred by their cardiologist to the exercise-based secondary prevention program. All exercise testing and training sessions will be performed without discontinuing the prescribed medications. On admission to the program, and quarterly during follow-up, each patient will perform a 1-km treadmill walk test as previously described (1k-TWT).
intervention type: Other
intervention name: physical activity intervention
description: 30, 60, 90 and 120 days after hospital discharge a clinical visit and session of physical activity training and program
arm group label: PHYSICAL ACTIVITY INTERVENTION
intervention type: Other
intervention name: standard of care
description: 30, 60, 90 and 120 days after hospital discharge a clinical visit with correct style life recommendation
arm group label: STANDARD OF CARE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University Hospital of Ferrara
investigator full name: Gianluca Campo
investigator title: Interventional cardiologist and Associate Professor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No