xml: <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/NCT05999110</url>
    </required_header>
    <id_info>
      <org_study_id>072590 - A3-COR</org_study_id>
      <nct_id>NCT05999110</nct_id>
    </id_info>
    <brief_title>Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR)</brief_title>
    <acronym>A3-COR</acronym>
    <official_title>Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation: Personalized Physical Exercise Protocol in After Acute Myocardial Infarction or Cardiovascular Risk and Knee Osteoarthritis, a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>European Regional Development Fund</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Loulé Municipal Council</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Albufeira Municipal Council</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Quarteira Parish Council</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv</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>
        This study aims to develop, implement, and determines the effectiveness of a personalized&#xD;
        medicine approach to each individual's phenotype, based on an innovative physical exercise&#xD;
        program to promote the treatment of pain and functional limitation resulting from knee&#xD;
        osteoarthritis (KOA) in patients recovering after acute myocardial infarction (AMI) and&#xD;
        cardiovascular risk (CVR).&#xD;
  &#xD;
        This randomized clinical study is important due to the lack of evidence according to the&#xD;
        effectiveness of a personalized physical exercise intervention in people after MI or CVR with&#xD;
        simultaneous KOA.&#xD;
  &#xD;
        Some studies have shown the existence of a relationship between OA and cardiovascular&#xD;
        diseases (CVD), including coronary artery disease, stroke, congestive heart failure,&#xD;
        peripheral arterial disease, cardiac procedures, or death related to CVD, since individuals&#xD;
        with OA have a higher prevalence of CVD than individuals without OA.&#xD;
  &#xD;
        Sedentary behaviour is a risk factor for AMI, CVR and KOA, and, at the same time, physical&#xD;
        exercise is a common non-pharmacological treatment for people suffering from these&#xD;
        conditions, namely in the control of joint pain, gains in functional capacity, and the&#xD;
        improvement of cardiorespiratory functional capacity, whose impact can be felt in level of&#xD;
        quality of life.&#xD;
  &#xD;
        Chronic diseases have a significant impact on the global burden of disease, particularly CVD&#xD;
        and OA, with the added presence of obesity also contributing to a high rate of all-cause&#xD;
        morbidity and mortality, representing a substantial health burden and with growing&#xD;
        implications for individuals, health systems and socioeconomic costs.&#xD;
  &#xD;
        The presence of OA seems to lead to an increased risk of developing CVD. Several mechanisms&#xD;
        have been proposed to explain this relationship. Chronic inflammation associated with OA is&#xD;
        one of the hypotheses suggested to explain the increased risk of CVD in these individuals.&#xD;
        Furthermore, the pain and disability associated with OA may also limit participation in&#xD;
        exercise/physical activity, influencing other risk factors associated with both chronic&#xD;
        diseases, such as weight gain.&#xD;
  &#xD;
        The lack of studies about physical exercise intervention on people that suffered acute&#xD;
        myocardial infarction or is in cardiovascular risk with simultaneous knee osteoarthritis and&#xD;
        the lack of offer of phase III cardiac rehabilitation in Algarve motivated the development of&#xD;
        this study, with the assumption of adopting a healthier lifestyle.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A new exercise protocol (A3-COR Protocol) for patients with knee osteoarthritis (OA)&#xD;
        recovering after acute myocardial infarction (AMI) or with cardiovascular risk (CVR) was&#xD;
        developed and implemented. The purpose of the A3-COR protocol is to improve quality of life,&#xD;
        functionality, and pain, through regular physical exercise facilitating an active and healthy&#xD;
        lifestyle.&#xD;
  &#xD;
        This clinical trial includes 2 parallel intervention groups with a pre- and post-test&#xD;
        analysis. In the exercise group (EG), the participants received a twelve weeks of a&#xD;
        supervised physical exercise program and in the control group (CG) there was no intervention.&#xD;
        Both groups had a session with a psychologist in behavioral change and with a nutritionist,&#xD;
        to promote changes in lifestyle and healthy eating habits.&#xD;
  &#xD;
        The two groups were assessed two times, the pre-test in the beginning of the study&#xD;
        (T0-Baseline) before starting the intervention or control and the post-test taking place at&#xD;
        the end of 12 weeks (T1-Post-test).&#xD;
  &#xD;
        The sample includes subjects from the community who met the defined eligibility criteria.&#xD;
        Participation in the study was voluntary and sample recruitment was carried out through&#xD;
        publicity materials, such as flyers posted at senior universities, institutions/associations,&#xD;
        municipalities, parish councils, sports complexes, health centres, among other public spaces&#xD;
        of interest.&#xD;
  &#xD;
        To calculate the sample size, the software G*Power was used. The primary outcome for this&#xD;
        clinical trial was the knee-related pain - KOOS subscale (score 0-100). According to the&#xD;
        literature, an important clinical difference in the KOOS subscales has been suggested to be 8&#xD;
        to 10 points. Based on the expected difference of 10 points between the intervention and&#xD;
        control groups and a standard deviation of 20 in Pain, 64 patients were required in each&#xD;
        group with a significance level of 0.05 and power of 80%. With an estimated dropout rate of&#xD;
        10%, a total number of 142 subjects were randomized to the EG (n = 71) and to the CG (n =&#xD;
        71).&#xD;
  &#xD;
        The screening for acute myocardial infarction was done with the presence of myocardial lesion&#xD;
        detected by abnormal cardiac biomarkers evidencing acute myocardial ischemia. The screening&#xD;
        of cardiovascular risk was done with the presence of any of the following cardiovascular risk&#xD;
        factors: hypertension, dyslipidemia, or smoking habits, according to the SCORE2 or SCORE2&#xD;
        O.P. The screening of knee osteoarthritis was done according to the National Clinical&#xD;
        Guideline Centre (2020) and American College of Rheumatology (2019) criteria. To identify&#xD;
        participants with cognitive impairment, the Montreal Cognitive Assessment (MoCA) instrument&#xD;
        was applied and cutoff points for the Portuguese population considering age and educational&#xD;
        level were used.&#xD;
  &#xD;
        The training sessions combine cardiorespiratory exercises for the development of aerobic&#xD;
        capacity and strength exercises, particularly resistant strength, in tasks that include open&#xD;
        and closed chain exercises, using your own body weight and equipment for this purpose. The&#xD;
        training zones are defined according to the performance of each individual in the test of&#xD;
        cardiorespiratory fitness in effort and test of maximum isokinetic strength, carried out in&#xD;
        the baseline.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 3, 2022</start_date>
    <completion_date type="Actual">July 28, 2023</completion_date>
    <primary_completion_date type="Actual">July 28, 2023</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>
      <intervention_model_description>Participants were assigned for two groups in parallel and a pre and post-test analysis was performed.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change the Level of Pain</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in pain subscore of Knee Injury and Osteoarthritis Outcome Score. The subscore can range between 0-100% and higher values mean less pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change the Level of Function</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in both function subscores of Knee Injury and Osteoarthritis Outcome Score. The subscores can range between 0-100% and higher values mean better function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change the Time Up and Go Test Performance</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in time (seconds) to perform the Timed Up and Go (TUG) test. Higher time of performance means poorer physical function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change the 30-Second Chair Stand Test Performance</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase of number of repetitions in 30-second chair stand test. Higher number of repetitions in 30 seconds means better physical function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change the 40m Fast Paced Walk Test Performance</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in time (seconds) of performance in 40m fast paced walk test. Higher time of performance means poorer physical function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change the Stair Climb Test Performance</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in time (seconds) of performance in Stair Climb Test (9 steps). Higher time of performance means poorer physical function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change the 6 Minutes Walk Test Performance</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in distance (meters) in 6 Minutes Walk Test. Higher distance in 6 minutes means better physical function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Quality of Life</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in any subscore or total score of Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), used to assess quality of life. Instrument can range between 0-100 and higher values mean better self-precepted quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Peak Torque of Quadriceps and Hamstring Muscles</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in peak torque (N/m). Peak Torque of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Work of Quadriceps and Hamstring Muscles</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in work per repetition (N/m). Work of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Power of Quadriceps and Hamstring Muscles</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in power per repetition (N/m). Power of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Peak torque time of Quadriceps and Hamstring Muscles</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in Peak torque time (s). Peak torque time of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Force of Quadriceps and Hamstring Muscles</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in Force (kg). Force of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Maximal Oxygen Uptake (VO2max)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in Maximal Oxygen Uptake (VO2max). Higher VO2max means better cardiorespiratory function. The VO2max was evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in First Ventilatory Threshold (VT1 - VO2)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in First Ventilatory Threshold (VT1 - VO2). Higher VT1 means better cardiorespiratory function. The VT1 was evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Respiratory Compensation Point (RCP - VO2)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in Respiratory Compensation Point (RCP - VO2). Higher RCP means better cardiorespiratory function. The RCP was evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in contraction time of lateral and medial vastus, bíceps femoris and semitendinous</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in contraction time (ms) of lateral and medial vastus, bíceps femoris and semitendinous. Higher contraction time means poor muscle function. The contraction time was measured by a tensiomyography system TMG S2. Tensiomyography assesses contractile properties of an isolated muscle by measuring a few parameters in response to a twitch contraction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in radial muscle belly displacement of lateral and medial vastus, bíceps femoris and semitendinous</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in radial muscle belly displacement (mm) of lateral and medial vastus, bíceps femoris and semitendinous. Higher radial muscle belly displacement means poor muscle function and muscle atrophy. The radial muscle belly displacement was measured by a tensiomyography system TMG S2. Tensiomyography assesses contractile properties of an isolated muscle by measuring a few parameters in response to a twitch contraction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in latence time of lateral and medial vastus, bíceps femoris and semitendinous</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in latence time (ms) of lateral and medial vastus, bíceps femoris and semitendinous. Higher latence time means poor muscle function. The latence time was measured by a tensiomyography system TMG S2. Tensiomyography assesses contractile properties of an isolated muscle by measuring a few parameters in response to a twitch contraction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Weight</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in weight (kg). Higher values of weight mean poor body composition and health. The weight was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in body mass index</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in body mass index (kg/m2). Higher values of body mass index mean poor body composition and health. The body mass index was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fat mass</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in fat mass (kg and %)). Higher values of fat mass mean poor body composition and health. The fat mass was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fat-free mass</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in fat-free mass (kg and %). Higher values of fat-free mass mean better body composition and health. The fat-free mass was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fat mass index</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in fat mass index (kg/m2). Higher values of fat mass index mean poor body composition and health. The fat mass index was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fat-free mass index</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in fat-free mass index (kg/m2). Higher values of fat-free mass index mean better body composition and health. The fat-free mass index was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in muscle mass index</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in muscle mass index (kg/m2). Higher values of muscle mass index mean better body composition and health. The muscle mass index was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in total body water</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in total body water (L and %). Higher values of total body water mean better body composition and health. The total body water was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Monitoring phase angle</measure>
      <time_frame>12 weeks</time_frame>
      <description>Keep the phase angle within normal limits for the age. The phase angle was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fat visceral fat</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in visceral fat (L). Higher values of visceral fat mean poor body composition and health. The visceral fat was measured using the bioimpedance technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in abdominal circumference</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in abdominal circumference (cm). Higher values of abdominal circumference mean poor body composition and health. The abdominal circumference was measured using measure tape, according to the STEPS Manual of the World Health Organization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Hand Grip Strength</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant increase in hand grip strength (kg). Higher hand grip strength is correlated with higher functional status. Maximum handgrip strength was measured with the Lafayette Digital and Dynamometer 5030D1 manual digital dynamometer on the dominant upper limb.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in c-reactive protein (inflammation level)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Significant decrease in c-reactive protein levels. Lower levels mean better inflammatory status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Rescue's Pain Medication Posology</measure>
      <time_frame>12 weeks</time_frame>
      <description>Decrease the necessity of rescue's pain medication related with knee osteoarthritis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in hospital readmissions related to Myocardial Infarction</measure>
      <time_frame>12 weeks</time_frame>
      <description>Decrease hospital readmissions related with Myocardial Infarction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change medical appointments number related with Myocardial Infarction</measure>
      <time_frame>12 weeks</time_frame>
      <description>Reduce the number of appointments related with Myocardial Infarction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change medical appointments number related with Knee Osteoarthritis</measure>
      <time_frame>12 weeks</time_frame>
      <description>Reduce the number of appointments related with Knee Osteoarthritis.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">142</enrollment>
    <condition>Osteoarthritis Knees Both</condition>
    <condition>Myocardial Infarction, Acute</condition>
    <condition>Hypertension</condition>
    <condition>Dyslipidemias</condition>
    <condition>Type 2 Diabetes</condition>
    <condition>Smoking Habit</condition>
    <arm_group>
      <arm_group_label>Exercise Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants received a twelve weeks of a supervised physical exercise program, based on aerobic and strength training. This group also received a session with a psychologist in behavioral change and nutritional advice session with a nutritionist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group received no intervention. The group received equally to the exercise group, a session with a psychologist in behavioral change and nutritional advice session with a nutritionist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical Exercise</intervention_name>
      <description>The intervention include a personalized physical exercise program based on aerobic and strength training, with prior warm-up and post cool-down exercises. All participantes also received a nutritional advice session and a psychological session in behavioral changes.</description>
      <arm_group_label>Exercise Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  50 or more years old; Knee pain; Three of the following criteria: Morning stiffness&#xD;
               during less than 30 minutes or knee crackling or touch-hypersensitivity or Bony&#xD;
               Prominences without Palpable heat (NICE and ACR criteria); Acute Myocardial Infarction&#xD;
               with myocardial lesion detected by abnormal cardiac biomarkers evidencing acute&#xD;
               myocardial ischemia; High risk level in SCORE2 or SCORE2 O.P. cardiovascular risk&#xD;
               algorithm or prior cardiovascular disease; Independent gait&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Occurrence of acute myocardial infarction with less than 12 months; Cognitive&#xD;
               impairment- Montreal Cognitive Assessment (MoCA); Type 1 diabetes or insulin&#xD;
               dependence; Pacemaker device; Knee prosthesis; Currently doing formal exercise session&#xD;
               for more that 30 minutes per week; Class III or IV angina according to Canadian&#xD;
               Cardiovascular Society criteria; Class III or IV symptoms according to New York Heart&#xD;
               Association criteria; Type 2 Myocardial Infarction; Uncontrolled and symptomatic&#xD;
               cardiac arrythmia with hemodynamic impact; Severe and symptomatic aortic valve&#xD;
               stenosis; Uncontrolled and symptomatic heart failure; Active myocarditis, pericarditis&#xD;
               or endocarditis; Acute aortic syndrome; Known or suspected desiccant aneurism; Acute&#xD;
               systemic infection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sandra R Pais, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>AD-ABC</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>AD-ABC</name>
        <address>
          <city>Faro</city>
          <state>Algarve</state>
          <zip>8005-139</zip>
          <country>Portugal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Portugal</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv</investigator_affiliation>
      <investigator_full_name>Sandra Rafael Pais</investigator_full_name>
      <investigator_title>Researcher</investigator_title>
    </responsible_party>
    <keyword>Knee Osteoarthritis</keyword>
    <keyword>Acute Myocardial Infarction</keyword>
    <keyword>Cardiovascular Risk</keyword>
    <keyword>Personalized Medicine</keyword>
    <keyword>Healthy Ageing</keyword>
    <keyword>Exercise</keyword>
    <keyword>Personalized Exercise</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Dyslipidemias</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999110
  org study id: 072590 - A3-COR
  nct id: NCT05999110
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to develop, implement, and determines the effectiveness of a personalized
        medicine approach to each individual's phenotype, based on an innovative physical exercise
        program to promote the treatment of pain and functional limitation resulting from knee
        osteoarthritis (KOA) in patients recovering after acute myocardial infarction (AMI) and
        cardiovascular risk (CVR).
  
        This randomized clinical study is important due to the lack of evidence according to the
        effectiveness of a personalized physical exercise intervention in people after MI or CVR with
        simultaneous KOA.
  
        Some studies have shown the existence of a relationship between OA and cardiovascular
        diseases (CVD), including coronary artery disease, stroke, congestive heart failure,
        peripheral arterial disease, cardiac procedures, or death related to CVD, since individuals
        with OA have a higher prevalence of CVD than individuals without OA.
  
        Sedentary behaviour is a risk factor for AMI, CVR and KOA, and, at the same time, physical
        exercise is a common non-pharmacological treatment for people suffering from these
        conditions, namely in the control of joint pain, gains in functional capacity, and the
        improvement of cardiorespiratory functional capacity, whose impact can be felt in level of
        quality of life.
  
        Chronic diseases have a significant impact on the global burden of disease, particularly CVD
        and OA, with the added presence of obesity also contributing to a high rate of all-cause
        morbidity and mortality, representing a substantial health burden and with growing
        implications for individuals, health systems and socioeconomic costs.
  
        The presence of OA seems to lead to an increased risk of developing CVD. Several mechanisms
        have been proposed to explain this relationship. Chronic inflammation associated with OA is
        one of the hypotheses suggested to explain the increased risk of CVD in these individuals.
        Furthermore, the pain and disability associated with OA may also limit participation in
        exercise/physical activity, influencing other risk factors associated with both chronic
        diseases, such as weight gain.
  
        The lack of studies about physical exercise intervention on people that suffered acute
        myocardial infarction or is in cardiovascular risk with simultaneous knee osteoarthritis and
        the lack of offer of phase III cardiac rehabilitation in Algarve motivated the development of
        this study, with the assumption of adopting a healthier lifestyle.
  A new exercise protocol (A3-COR Protocol) for patients with knee osteoarthritis (OA)
        recovering after acute myocardial infarction (AMI) or with cardiovascular risk (CVR) was
        developed and implemented. The purpose of the A3-COR protocol is to improve quality of life,
        functionality, and pain, through regular physical exercise facilitating an active and healthy
        lifestyle.
  
        This clinical trial includes 2 parallel intervention groups with a pre- and post-test
        analysis. In the exercise group (EG), the participants received a twelve weeks of a
        supervised physical exercise program and in the control group (CG) there was no intervention.
        Both groups had a session with a psychologist in behavioral change and with a nutritionist,
        to promote changes in lifestyle and healthy eating habits.
  
        The two groups were assessed two times, the pre-test in the beginning of the study
        (T0-Baseline) before starting the intervention or control and the post-test taking place at
        the end of 12 weeks (T1-Post-test).
  
        The sample includes subjects from the community who met the defined eligibility criteria.
        Participation in the study was voluntary and sample recruitment was carried out through
        publicity materials, such as flyers posted at senior universities, institutions/associations,
        municipalities, parish councils, sports complexes, health centres, among other public spaces
        of interest.
  
        To calculate the sample size, the software G*Power was used. The primary outcome for this
        clinical trial was the knee-related pain - KOOS subscale (score 0-100). According to the
        literature, an important clinical difference in the KOOS subscales has been suggested to be 8
        to 10 points. Based on the expected difference of 10 points between the intervention and
        control groups and a standard deviation of 20 in Pain, 64 patients were required in each
        group with a significance level of 0.05 and power of 80%. With an estimated dropout rate of
        10%, a total number of 142 subjects were randomized to the EG (n = 71) and to the CG (n =
        71).
  
        The screening for acute myocardial infarction was done with the presence of myocardial lesion
        detected by abnormal cardiac biomarkers evidencing acute myocardial ischemia. The screening
        of cardiovascular risk was done with the presence of any of the following cardiovascular risk
        factors: hypertension, dyslipidemia, or smoking habits, according to the SCORE2 or SCORE2
        O.P. The screening of knee osteoarthritis was done according to the National Clinical
        Guideline Centre (2020) and American College of Rheumatology (2019) criteria. To identify
        participants with cognitive impairment, the Montreal Cognitive Assessment (MoCA) instrument
        was applied and cutoff points for the Portuguese population considering age and educational
        level were used.
  
        The training sessions combine cardiorespiratory exercises for the development of aerobic
        capacity and strength exercises, particularly resistant strength, in tasks that include open
        and closed chain exercises, using your own body weight and equipment for this purpose. The
        training zones are defined according to the performance of each individual in the test of
        cardiorespiratory fitness in effort and test of maximum isokinetic strength, carried out in
        the baseline.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants were assigned for two groups in parallel and a pre and post-test analysis was performed.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Change the Level of Pain
  time frame: 12 weeks
  description: Significant increase in pain subscore of Knee Injury and Osteoarthritis Outcome Score. The subscore can range between 0-100% and higher values mean less pain.
  measure: Change the Level of Function
  time frame: 12 weeks
  description: Significant increase in both function subscores of Knee Injury and Osteoarthritis Outcome Score. The subscores can range between 0-100% and higher values mean better function.
  measure: Change the Time Up and Go Test Performance
  time frame: 12 weeks
  description: Significant decrease in time (seconds) to perform the Timed Up and Go (TUG) test. Higher time of performance means poorer physical function.
  measure: Change the 30-Second Chair Stand Test Performance
  time frame: 12 weeks
  description: Significant increase of number of repetitions in 30-second chair stand test. Higher number of repetitions in 30 seconds means better physical function.
  measure: Change the 40m Fast Paced Walk Test Performance
  time frame: 12 weeks
  description: Significant decrease in time (seconds) of performance in 40m fast paced walk test. Higher time of performance means poorer physical function.
  measure: Change the Stair Climb Test Performance
  time frame: 12 weeks
  description: Significant decrease in time (seconds) of performance in Stair Climb Test (9 steps). Higher time of performance means poorer physical function.
  measure: Change the 6 Minutes Walk Test Performance
  time frame: 12 weeks
  description: Significant increase in distance (meters) in 6 Minutes Walk Test. Higher distance in 6 minutes means better physical function.
  measure: Change in Quality of Life
  time frame: 12 weeks
  description: Significant increase in any subscore or total score of Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), used to assess quality of life. Instrument can range between 0-100 and higher values mean better self-precepted quality of life.
  measure: Change in Peak Torque of Quadriceps and Hamstring Muscles
  time frame: 12 weeks
  description: Significant increase in peak torque (N/m). Peak Torque of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
  measure: Change in Work of Quadriceps and Hamstring Muscles
  time frame: 12 weeks
  description: Significant increase in work per repetition (N/m). Work of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
  measure: Change in Power of Quadriceps and Hamstring Muscles
  time frame: 12 weeks
  description: Significant increase in power per repetition (N/m). Power of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
  measure: Change in Peak torque time of Quadriceps and Hamstring Muscles
  time frame: 12 weeks
  description: Significant increase in Peak torque time (s). Peak torque time of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
  measure: Change in Force of Quadriceps and Hamstring Muscles
  time frame: 12 weeks
  description: Significant increase in Force (kg). Force of Quadriceps and Hamstring Muscles was measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
  measure: Change in Maximal Oxygen Uptake (VO2max)
  time frame: 12 weeks
  description: Significant increase in Maximal Oxygen Uptake (VO2max). Higher VO2max means better cardiorespiratory function. The VO2max was evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.
  measure: Change in First Ventilatory Threshold (VT1 - VO2)
  time frame: 12 weeks
  description: Significant increase in First Ventilatory Threshold (VT1 - VO2). Higher VT1 means better cardiorespiratory function. The VT1 was evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.
  measure: Change in Respiratory Compensation Point (RCP - VO2)
  time frame: 12 weeks
  description: Significant increase in Respiratory Compensation Point (RCP - VO2). Higher RCP means better cardiorespiratory function. The RCP was evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.
  measure: Change in contraction time of lateral and medial vastus, bíceps femoris and semitendinous
  time frame: 12 weeks
  description: Significant decrease in contraction time (ms) of lateral and medial vastus, bíceps femoris and semitendinous. Higher contraction time means poor muscle function. The contraction time was measured by a tensiomyography system TMG S2. Tensiomyography assesses contractile properties of an isolated muscle by measuring a few parameters in response to a twitch contraction.
  measure: Change in radial muscle belly displacement of lateral and medial vastus, bíceps femoris and semitendinous
  time frame: 12 weeks
  description: Significant decrease in radial muscle belly displacement (mm) of lateral and medial vastus, bíceps femoris and semitendinous. Higher radial muscle belly displacement means poor muscle function and muscle atrophy. The radial muscle belly displacement was measured by a tensiomyography system TMG S2. Tensiomyography assesses contractile properties of an isolated muscle by measuring a few parameters in response to a twitch contraction.
  measure: Change in latence time of lateral and medial vastus, bíceps femoris and semitendinous
  time frame: 12 weeks
  description: Significant decrease in latence time (ms) of lateral and medial vastus, bíceps femoris and semitendinous. Higher latence time means poor muscle function. The latence time was measured by a tensiomyography system TMG S2. Tensiomyography assesses contractile properties of an isolated muscle by measuring a few parameters in response to a twitch contraction.
  measure: Change in Weight
  time frame: 12 weeks
  description: Significant decrease in weight (kg). Higher values of weight mean poor body composition and health. The weight was measured using the bioimpedance technique.
  measure: Change in body mass index
  time frame: 12 weeks
  description: Significant decrease in body mass index (kg/m2). Higher values of body mass index mean poor body composition and health. The body mass index was measured using the bioimpedance technique.
  measure: Change in fat mass
  time frame: 12 weeks
  description: Significant decrease in fat mass (kg and %)). Higher values of fat mass mean poor body composition and health. The fat mass was measured using the bioimpedance technique.
  measure: Change in fat-free mass
  time frame: 12 weeks
  description: Significant increase in fat-free mass (kg and %). Higher values of fat-free mass mean better body composition and health. The fat-free mass was measured using the bioimpedance technique.
  measure: Change in fat mass index
  time frame: 12 weeks
  description: Significant decrease in fat mass index (kg/m2). Higher values of fat mass index mean poor body composition and health. The fat mass index was measured using the bioimpedance technique.
  measure: Change in fat-free mass index
  time frame: 12 weeks
  description: Significant increase in fat-free mass index (kg/m2). Higher values of fat-free mass index mean better body composition and health. The fat-free mass index was measured using the bioimpedance technique.
  measure: Change in muscle mass index
  time frame: 12 weeks
  description: Significant increase in muscle mass index (kg/m2). Higher values of muscle mass index mean better body composition and health. The muscle mass index was measured using the bioimpedance technique.
  measure: Change in total body water
  time frame: 12 weeks
  description: Significant increase in total body water (L and %). Higher values of total body water mean better body composition and health. The total body water was measured using the bioimpedance technique.
  measure: Monitoring phase angle
  time frame: 12 weeks
  description: Keep the phase angle within normal limits for the age. The phase angle was measured using the bioimpedance technique.
  measure: Change in fat visceral fat
  time frame: 12 weeks
  description: Significant decrease in visceral fat (L). Higher values of visceral fat mean poor body composition and health. The visceral fat was measured using the bioimpedance technique.
  measure: Change in abdominal circumference
  time frame: 12 weeks
  description: Significant decrease in abdominal circumference (cm). Higher values of abdominal circumference mean poor body composition and health. The abdominal circumference was measured using measure tape, according to the STEPS Manual of the World Health Organization.
  measure: Change in Hand Grip Strength
  time frame: 12 weeks
  description: Significant increase in hand grip strength (kg). Higher hand grip strength is correlated with higher functional status. Maximum handgrip strength was measured with the Lafayette Digital and Dynamometer 5030D1 manual digital dynamometer on the dominant upper limb.
  measure: Change in c-reactive protein (inflammation level)
  time frame: 12 weeks
  description: Significant decrease in c-reactive protein levels. Lower levels mean better inflammatory status.
  measure: Change in Rescue's Pain Medication Posology
  time frame: 12 weeks
  description: Decrease the necessity of rescue's pain medication related with knee osteoarthritis.
  measure: Change in hospital readmissions related to Myocardial Infarction
  time frame: 12 weeks
  description: Decrease hospital readmissions related with Myocardial Infarction.
  measure: Change medical appointments number related with Myocardial Infarction
  time frame: 12 weeks
  description: Reduce the number of appointments related with Myocardial Infarction.
  measure: Change medical appointments number related with Knee Osteoarthritis
  time frame: 12 weeks
  description: Reduce the number of appointments related with Knee Osteoarthritis.
  arm group label: Exercise Group
  arm group type: Experimental
  description: The participants received a twelve weeks of a supervised physical exercise program, based on aerobic and strength training. This group also received a session with a psychologist in behavioral change and nutritional advice session with a nutritionist.
  arm group label: Control Group
  arm group type: No Intervention
  description: This group received no intervention. The group received equally to the exercise group, a session with a psychologist in behavioral change and nutritional advice session with a nutritionist.
  intervention type: Other
  intervention name: Physical Exercise
  description: The intervention include a personalized physical exercise program based on aerobic and strength training, with prior warm-up and post cool-down exercises. All participantes also received a nutritional advice session and a psychological session in behavioral changes.
  arm group label: Exercise Group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sandra R Pais, PhD
  role: Principal Investigator
  affiliation: AD-ABC
  facility: 
  country: Portugal
  responsible party type: Principal Investigator
  investigator affiliation: Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv
  investigator full name: Sandra Rafael Pais
  investigator title: Researcher
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Myocardial Infarction
  mesh term: Dyslipidemias
  mesh term: Infarction