<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/NCT01732419</url>
  </required_header>
  <id_info>
    <org_study_id>CARDSS FIT@Home</org_study_id>
    <nct_id>NCT01732419</nct_id>
  </id_info>
  <brief_title>Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation</brief_title>
  <acronym>FIT@Home</acronym>
  <official_title>Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maxima Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maxima Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical exercise training appears effective for low to moderate patients assigned to cardiac&#xD;
      rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity&#xD;
      levels often drop after attending the last supervised rehabilitation session.&#xD;
&#xD;
      This study will compare home based physical exercise training including telemonitoring with&#xD;
      regular centre based physical exercise training. Main outcome measures are the change in&#xD;
      physical activity and the change in physical fitness (peak Oxygen uptake) after the initial&#xD;
      rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are&#xD;
      cost-effectiveness, training adherence, health-related quality of life and patient&#xD;
      satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical training has beneficial effects on exercise capacity, cardiac function, quality of&#xD;
      life and mortality in patients with acute cardiovascular syndrome or after cardiac surgery&#xD;
      and is therefore one of the main aspects of cardiac rehabilitation. However, adherence to&#xD;
      this therapy is low and effects tempt to decrease directly after the treatment period.&#xD;
&#xD;
      The objective of this study is to compare the effects of home-based exercise training (HT)&#xD;
      with telemonitoring guidance and regular centre-based exercise training (CT) on physical&#xD;
      fitness (PF), assessed by peak oxygen uptake, and physical activity (PA), assessed by&#xD;
      physical activity energy expenditure (PAEE), in low to moderate risk cardiac rehabilitation&#xD;
      (CR) patients. Secondary endpoints are cost-effectiveness, training adherence, health-related&#xD;
      quality of life (QoL) and patient satisfaction.&#xD;
&#xD;
      Single-centre randomized controlled trial. CR patients are randomized to HT (n=45) or CT&#xD;
      (n=45). Assessments are performed at baseline, 12 weeks and 1 year, consisting of maximal&#xD;
      exercise testing with respiratory gas exchange analysis, assessment of PAEE, QoL (also at 6&#xD;
      months), patient satisfaction (at 12 weeks only) and health care costs (12 weeks, 6 months&#xD;
      and 1 year) Study population: Low to moderate risk patients entering outpatient CR after an&#xD;
      acute coronary syndrome or revascularization with internet access and PC at home.&#xD;
&#xD;
      12-week training program (24-36 one-hour sessions) at 70-85% of their maximal heart rate&#xD;
      (HR). In the CT group training is supervised by a physical therapist; in the HT group&#xD;
      training is performed in the home environment using a HR monitor to determine training&#xD;
      intensity and with weekly feedback / motivation by an exercise specialist who has access to&#xD;
      the online HR-data. After 12 weeks, subjects in the HT group are encouraged to continue using&#xD;
      the HR monitor.&#xD;
&#xD;
      Main study parameters/endpoints: Primary endpoints: PF (peak oxygen uptake) and PA (physical&#xD;
      activity energy expenditure, PAEE) assessed by a tri-axial accelerometer and HR monitor.&#xD;
      Secondary endpoints: training adherence, QoL (SF-36) and patient satisfaction (CQ index).&#xD;
&#xD;
      Exercise training performed by patients after Acute Coronary Disease (ACS) and&#xD;
      revascularization, classified as low to moderate risk, is considered to be safe. The training&#xD;
      program that will be used in this study has been evaluated in a similar population of elderly&#xD;
      cardiac patients without any documented harmful effects. In order to reduce potential risks&#xD;
      of exercise training all patients perform a maximal cardiopulmonary exercise test at&#xD;
      baseline, excluding patients with myocardial ischaemia and ventricular arrhythmias during&#xD;
      exercise. The first three training sessions will be under supervision of trained&#xD;
      physiotherapist in a clinical setting. The patients will receive a heart rate monitor and&#xD;
      accelerometer to use at home. These monitors are developed and optimized to cause minimal&#xD;
      physical discomfort and are non-invasive. During the measurement periods, all patients are&#xD;
      asked to wear the monitors continuously for 5 days and to note the physical activities&#xD;
      performed. The HT group will use the HR monitors during their physical trainings as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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 Fitness</measure>
    <time_frame>Measured after 12 weeks and after one year</time_frame>
    <description>Changes in peak oxygen uptake (VO2max) in mL O2/kg/min</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Activity Level (PAL)</measure>
    <time_frame>measured after 12 weeks and after one year</time_frame>
    <description>PAL is calculated by combining data from an accelerometer with data from a heart monitor, after wearing both for five days continuously. To determine PAL, physical activity energy expenditure is divided by resting metabolic rate, calculated by the Harris-Benedict equation. PAL expressed a person's daily energy expenditure. When PAL is used to classify the intensity of an activity, PAL&lt;3, PAL&lt;6 and PAL&gt;6 are characterized as light, moderate and vigorous intensity activities respectively. An average daily PAL of 1.2 represents the activity level of a bed-bound subject, while the average PAL for the adult population is 1.7.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Training Adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>Provides information on the average amount of training sessions were performed during the 12 week cardiac rehabilitation program. Both groups received the advice to train at least 2 times a week for 12 weeks (thus 24 sessions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>measured at baseline, at discharge (12 weeks), and follow-up (one year)</time_frame>
    <description>Health-related quality of life will be assessed by the MacNew questionnaire. The items and scale are scored from 1 (low health-related Quality of Life) to 7 (High health-related Quality of Life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Measured at CR discharge (12 weeks)</time_frame>
    <description>Patient satisfaction is measured directly after CR discharge (12 weeks) using the Consumer Quality Index, a standardized survey method combining the inventory of patient experiences with an assessment of their priority. Results are provided on a scale of 1 (very low satisfaction) to 10 (very high satisfaction).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Home-based training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.&#xD;
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Centre-based training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home-based training</intervention_name>
    <description>Home-based exercise training for cardiac patients.</description>
    <arm_group_label>Home-based training</arm_group_label>
    <other_name>Homebased exercise training</other_name>
    <other_name>Home-based cardiac rehabilitation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Centre-based training</intervention_name>
    <description>Usual exercise training in an outpatient setting.</description>
    <arm_group_label>Centre-based training</arm_group_label>
    <other_name>Hospital-based training</other_name>
    <other_name>Outpatient exercise training</other_name>
    <other_name>Centre-based cardiac rehabilitation</other_name>
    <other_name>hospital-based cardiac rehabilitation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients with an ACS (including non ST and ST elevation myocardial infarction and&#xD;
             unstable angina) or a cardiac revascularization procedure (PCI or CABG) entering&#xD;
             outpatient CR at Maxima Medical Center.&#xD;
&#xD;
          -  Indication for exercise training according to the Dutch clinical algorithm for&#xD;
             assessment of patient needs in cardiac rehabilitation.&#xD;
&#xD;
          -  Internet access and PC at home (i.e. more than 90 percent of the Dutch household)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  High risk according to the Dutch CR practice guideline.&#xD;
&#xD;
          -  Systolic heart failure (left ventricular ejection fraction of more than 40 percent.&#xD;
&#xD;
          -  New York Heart Association class III-IV (i.e. breathlessness during light exercise or&#xD;
             at rest).&#xD;
&#xD;
          -  Severe arrhythmia.&#xD;
&#xD;
          -  Hemodynamically significant valvular disease.&#xD;
&#xD;
          -  Implantable cardioverter-defibrillator (ICD) implantation&#xD;
&#xD;
          -  Heart transplantation.&#xD;
&#xD;
          -  Chronic angina or silent ischemia.&#xD;
&#xD;
          -  Comorbidity impairing exercise capacity (e.g. COPD, diabetes mellitus, peripheral&#xD;
             vascular disease and orthopedic or neurological conditions).&#xD;
&#xD;
          -  Severe psychological or cognitive impairments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hareld Kemps, Dhr. MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maxima Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Máxima Medisch Centrum</name>
      <address>
        <city>Veldhoven</city>
        <zip>5504 DB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>October 24, 2017</results_first_submitted>
  <results_first_submitted_qc>August 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 29, 2019</results_first_posted>
  <last_update_submitted>August 28, 2019</last_update_submitted>
  <last_update_submitted_qc>August 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maxima Medical Center</investigator_affiliation>
    <investigator_full_name>H.Kemps</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation, exercise therapy, coronary artery disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Home-based Training</title>
          <description>After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.&#xD;
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.&#xD;
Home-based training: Home-based exercise training for cardiac patients.</description>
        </group>
        <group group_id="P2">
          <title>Centre-based Training</title>
          <description>Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.&#xD;
Centre-based training: Usual exercise training in an outpatient setting.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline measurements</population>
      <group_list>
        <group group_id="B1">
          <title>Home-based Training</title>
          <description>After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.&#xD;
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.&#xD;
Home-based training: Home-based exercise training for cardiac patients.</description>
        </group>
        <group group_id="B2">
          <title>Centre-based Training</title>
          <description>Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.&#xD;
Centre-based training: Usual exercise training in an outpatient setting.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.5" spread="8.8"/>
                    <measurement group_id="B2" value="57.7" spread="8.7"/>
                    <measurement group_id="B3" value="59.2" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Physical Fitness</title>
        <description>Changes in peak oxygen uptake (VO2max) in mL O2/kg/min</description>
        <time_frame>Measured after 12 weeks and after one year</time_frame>
        <population>patients finished the study</population>
        <group_list>
          <group group_id="O1">
            <title>Home-based Training</title>
            <description>After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.&#xD;
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.&#xD;
Home-based training: Home-based exercise training for cardiac patients.</description>
          </group>
          <group group_id="O2">
            <title>Centre-based Training</title>
            <description>Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.&#xD;
Centre-based training: Usual exercise training in an outpatient setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Fitness</title>
          <description>Changes in peak oxygen uptake (VO2max) in mL O2/kg/min</description>
          <population>patients finished the study</population>
          <units>ml O2/kg/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.4" spread="6.7"/>
                    <measurement group_id="O2" value="24.0" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge CR (12 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.9" spread="7.5"/>
                    <measurement group_id="O2" value="26.5" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow up (1 year)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" spread="6.9"/>
                    <measurement group_id="O2" value="27.5" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Physical Activity Level (PAL)</title>
        <description>PAL is calculated by combining data from an accelerometer with data from a heart monitor, after wearing both for five days continuously. To determine PAL, physical activity energy expenditure is divided by resting metabolic rate, calculated by the Harris-Benedict equation. PAL expressed a person's daily energy expenditure. When PAL is used to classify the intensity of an activity, PAL&lt;3, PAL&lt;6 and PAL&gt;6 are characterized as light, moderate and vigorous intensity activities respectively. An average daily PAL of 1.2 represents the activity level of a bed-bound subject, while the average PAL for the adult population is 1.7.</description>
        <time_frame>measured after 12 weeks and after one year</time_frame>
        <population>Patients finished the study</population>
        <group_list>
          <group group_id="O1">
            <title>Home-based Training</title>
            <description>After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.&#xD;
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.&#xD;
Home-based training: Home-based exercise training for cardiac patients.</description>
          </group>
          <group group_id="O2">
            <title>Centre-based Training</title>
            <description>Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.&#xD;
Centre-based training: Usual exercise training in an outpatient setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Activity Level (PAL)</title>
          <description>PAL is calculated by combining data from an accelerometer with data from a heart monitor, after wearing both for five days continuously. To determine PAL, physical activity energy expenditure is divided by resting metabolic rate, calculated by the Harris-Benedict equation. PAL expressed a person's daily energy expenditure. When PAL is used to classify the intensity of an activity, PAL&lt;3, PAL&lt;6 and PAL&gt;6 are characterized as light, moderate and vigorous intensity activities respectively. An average daily PAL of 1.2 represents the activity level of a bed-bound subject, while the average PAL for the adult population is 1.7.</description>
          <population>Patients finished the study</population>
          <units>PAL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.09" spread="0.92"/>
                    <measurement group_id="O2" value="1.95" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge CR (12 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="0.99"/>
                    <measurement group_id="O2" value="2.38" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow up (1 year)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="1.06"/>
                    <measurement group_id="O2" value="2.13" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Training Adherence</title>
        <description>Provides information on the average amount of training sessions were performed during the 12 week cardiac rehabilitation program. Both groups received the advice to train at least 2 times a week for 12 weeks (thus 24 sessions).</description>
        <time_frame>12 weeks</time_frame>
        <population>Patients finished the CR program</population>
        <group_list>
          <group group_id="O1">
            <title>Home-based Training</title>
            <description>After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.&#xD;
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.&#xD;
Home-based training: Home-based exercise training for cardiac patients.</description>
          </group>
          <group group_id="O2">
            <title>Centre-based Training</title>
            <description>Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.&#xD;
Centre-based training: Usual exercise training in an outpatient setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Training Adherence</title>
          <description>Provides information on the average amount of training sessions were performed during the 12 week cardiac rehabilitation program. Both groups received the advice to train at least 2 times a week for 12 weeks (thus 24 sessions).</description>
          <population>Patients finished the CR program</population>
          <units>Exercise sessions completed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" spread="6.8"/>
                    <measurement group_id="O2" value="20.6" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Related Quality of Life</title>
        <description>Health-related quality of life will be assessed by the MacNew questionnaire. The items and scale are scored from 1 (low health-related Quality of Life) to 7 (High health-related Quality of Life).</description>
        <time_frame>measured at baseline, at discharge (12 weeks), and follow-up (one year)</time_frame>
        <population>Patients finished the study</population>
        <group_list>
          <group group_id="O1">
            <title>Home-based Training</title>
            <description>After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.&#xD;
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.&#xD;
Home-based training: Home-based exercise training for cardiac patients.</description>
          </group>
          <group group_id="O2">
            <title>Centre-based Training</title>
            <description>Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.&#xD;
Centre-based training: Usual exercise training in an outpatient setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Quality of Life</title>
          <description>Health-related quality of life will be assessed by the MacNew questionnaire. The items and scale are scored from 1 (low health-related Quality of Life) to 7 (High health-related Quality of Life).</description>
          <population>Patients finished the study</population>
          <units>Units of a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.62" spread="0.20"/>
                    <measurement group_id="O2" value="5.45" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge CR (12 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" spread="0.13"/>
                    <measurement group_id="O2" value="5.90" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow up (one year)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.75" spread="0.10"/>
                    <measurement group_id="O2" value="5.43" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction is measured directly after CR discharge (12 weeks) using the Consumer Quality Index, a standardized survey method combining the inventory of patient experiences with an assessment of their priority. Results are provided on a scale of 1 (very low satisfaction) to 10 (very high satisfaction).</description>
        <time_frame>Measured at CR discharge (12 weeks)</time_frame>
        <population>Patients finished the CR program (12 weeks)</population>
        <group_list>
          <group group_id="O1">
            <title>Home-based Training</title>
            <description>After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.&#xD;
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.&#xD;
Home-based training: Home-based exercise training for cardiac patients.</description>
          </group>
          <group group_id="O2">
            <title>Centre-based Training</title>
            <description>Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.&#xD;
Centre-based training: Usual exercise training in an outpatient setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction is measured directly after CR discharge (12 weeks) using the Consumer Quality Index, a standardized survey method combining the inventory of patient experiences with an assessment of their priority. Results are provided on a scale of 1 (very low satisfaction) to 10 (very high satisfaction).</description>
          <population>Patients finished the CR program (12 weeks)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="1.0"/>
                    <measurement group_id="O2" value="8.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the study period (1 year)</time_frame>
      <desc>The definition of adverse events did not differ from the clinicaltrials.gov definition.</desc>
      <group_list>
        <group group_id="E1">
          <title>Home-based Training</title>
          <description>After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.&#xD;
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.&#xD;
Home-based training: Home-based exercise training for cardiac patients.</description>
        </group>
        <group group_id="E2">
          <title>Centre-based Training</title>
          <description>Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.&#xD;
Centre-based training: Usual exercise training in an outpatient setting.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Heart attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Rehospitalization due to cardiac reasons</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>blinding of patients due to nature of the study protocol</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. J. Kraal</name_or_title>
      <organization>Maxima Medical Center</organization>
      <phone>+31612520944</phone>
      <email>j.kraal@mmc.nl</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01732419
org study id: CARDSS FIT@Home
nct id: NCT01732419
lead sponsor: 
has dmc: No
Physical exercise training appears effective for low to moderate patients assigned to cardiac
      rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity
      levels often drop after attending the last supervised rehabilitation session.

      This study will compare home based physical exercise training including telemonitoring with
      regular centre based physical exercise training. Main outcome measures are the change in
      physical activity and the change in physical fitness (peak Oxygen uptake) after the initial
      rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are
      cost-effectiveness, training adherence, health-related quality of life and patient
      satisfaction.
Physical training has beneficial effects on exercise capacity, cardiac function, quality of
      life and mortality in patients with acute cardiovascular syndrome or after cardiac surgery
      and is therefore one of the main aspects of cardiac rehabilitation. However, adherence to
      this therapy is low and effects tempt to decrease directly after the treatment period.

      The objective of this study is to compare the effects of home-based exercise training (HT)
      with telemonitoring guidance and regular centre-based exercise training (CT) on physical
      fitness (PF), assessed by peak oxygen uptake, and physical activity (PA), assessed by
      physical activity energy expenditure (PAEE), in low to moderate risk cardiac rehabilitation
      (CR) patients. Secondary endpoints are cost-effectiveness, training adherence, health-related
      quality of life (QoL) and patient satisfaction.

      Single-centre randomized controlled trial. CR patients are randomized to HT (n=45) or CT
      (n=45). Assessments are performed at baseline, 12 weeks and 1 year, consisting of maximal
      exercise testing with respiratory gas exchange analysis, assessment of PAEE, QoL (also at 6
      months), patient satisfaction (at 12 weeks only) and health care costs (12 weeks, 6 months
      and 1 year) Study population: Low to moderate risk patients entering outpatient CR after an
      acute coronary syndrome or revascularization with internet access and PC at home.

      12-week training program (24-36 one-hour sessions) at 70-85% of their maximal heart rate
      (HR). In the CT group training is supervised by a physical therapist; in the HT group
      training is performed in the home environment using a HR monitor to determine training
      intensity and with weekly feedback / motivation by an exercise specialist who has access to
      the online HR-data. After 12 weeks, subjects in the HT group are encouraged to continue using
      the HR monitor.

      Main study parameters/endpoints: Primary endpoints: PF (peak oxygen uptake) and PA (physical
      activity energy expenditure, PAEE) assessed by a tri-axial accelerometer and HR monitor.
      Secondary endpoints: training adherence, QoL (SF-36) and patient satisfaction (CQ index).

      Exercise training performed by patients after Acute Coronary Disease (ACS) and
      revascularization, classified as low to moderate risk, is considered to be safe. The training
      program that will be used in this study has been evaluated in a similar population of elderly
      cardiac patients without any documented harmful effects. In order to reduce potential risks
      of exercise training all patients perform a maximal cardiopulmonary exercise test at
      baseline, excluding patients with myocardial ischaemia and ventricular arrhythmias during
      exercise. The first three training sessions will be under supervision of trained
      physiotherapist in a clinical setting. The patients will receive a heart rate monitor and
      accelerometer to use at home. These monitors are developed and optimized to cause minimal
      physical discomfort and are non-invasive. During the measurement periods, all patients are
      asked to wear the monitors continuously for 5 days and to note the physical activities
      performed. The HT group will use the HR monitors during their physical trainings as well.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Physical Fitness
time frame: Measured after 12 weeks and after one year
description: Changes in peak oxygen uptake (VO2max) in mL O2/kg/min
measure: Physical Activity Level (PAL)
time frame: measured after 12 weeks and after one year
description: PAL is calculated by combining data from an accelerometer with data from a heart monitor, after wearing both for five days continuously. To determine PAL, physical activity energy expenditure is divided by resting metabolic rate, calculated by the Harris-Benedict equation. PAL expressed a person's daily energy expenditure. When PAL is used to classify the intensity of an activity, PAL<3, PAL<6 and PAL>6 are characterized as light, moderate and vigorous intensity activities respectively. An average daily PAL of 1.2 represents the activity level of a bed-bound subject, while the average PAL for the adult population is 1.7.
measure: Training Adherence
time frame: 12 weeks
description: Provides information on the average amount of training sessions were performed during the 12 week cardiac rehabilitation program. Both groups received the advice to train at least 2 times a week for 12 weeks (thus 24 sessions).
measure: Health Related Quality of Life
time frame: measured at baseline, at discharge (12 weeks), and follow-up (one year)
description: Health-related quality of life will be assessed by the MacNew questionnaire. The items and scale are scored from 1 (low health-related Quality of Life) to 7 (High health-related Quality of Life).
measure: Patient Satisfaction
time frame: Measured at CR discharge (12 weeks)
description: Patient satisfaction is measured directly after CR discharge (12 weeks) using the Consumer Quality Index, a standardized survey method combining the inventory of patient experiences with an assessment of their priority. Results are provided on a scale of 1 (very low satisfaction) to 10 (very high satisfaction).
arm group label: Home-based training
arm group type: Experimental
description: After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
arm group label: Centre-based training
arm group type: Active Comparator
description: Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
intervention type: Behavioral
intervention name: Home-based training
description: Home-based exercise training for cardiac patients.
arm group label: Home-based training
other name: Homebased exercise training
other name: Home-based cardiac rehabilitation
intervention type: Behavioral
intervention name: Centre-based training
description: Usual exercise training in an outpatient setting.
arm group label: Centre-based training
other name: Hospital-based training
other name: Outpatient exercise training
other name: Centre-based cardiac rehabilitation
other name: hospital-based cardiac rehabilitation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hareld Kemps, Dhr. MD.
role: Principal Investigator
affiliation: Maxima Medical Center
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Maxima Medical Center
investigator full name: H.Kemps
investigator title: MD, PhD
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Infarction
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: blinding of patients due to nature of the study protocol
point of contact: 