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/NCT05987410</url>
    </required_header>
    <id_info>
      <org_study_id>27/2023/CE_FdG/FC/SA</org_study_id>
      <nct_id>NCT05987410</nct_id>
    </id_info>
    <brief_title>EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Patients</brief_title>
    <acronym>VENERE</acronym>
    <official_title>EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Diabetic patiEnts With Cardiovascular Disease. The VENERE Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Don Carlo Gnocchi Onlus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Don Carlo Gnocchi Onlus</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Nordic Walking (NW) is a biomechanically correct walking technique that originated in Finland&#xD;
        in the 1930s as an off-season training method for cross-country skiers. In the NW, the use of&#xD;
        special sticks is combined with &quot;conventional&quot; walking: this involves a greater caloric&#xD;
        expenditure, with an energy consumption higher by 20-30% compared to walking without sticks,&#xD;
        and also toning of the upper part of the body, in particular triceps, shoulders and back, and&#xD;
        the involvement of about 90% of the body's muscles, while maintaining a reduced load on&#xD;
        ligaments and joints (Baek &amp; Ha, 2021). The NW acts simultaneously and effectively on&#xD;
        different components of fitness: coordination, endurance, strength, and mobility. It does not&#xD;
        require sudden accelerations and is based on a technique that is easy to learn (with the help&#xD;
        of an instructor), especially as regards maintaining correct posture. Finally, in addition to&#xD;
        the cardiovascular benefits, NW has also been shown to effectively reduce the risk of falls&#xD;
        in the elderly. The study is a single-center, randomized controlled trial (RCT), with a&#xD;
        three-parallel-arm design, open-label. The primary objective is to evaluate the efficacy (in&#xD;
        terms of cardiovascular performance), safety, and adherence (in terms of dropout rate) to the&#xD;
        exercise prescription after 6 and 12 months follow-up of a 3-month NW intervention compared&#xD;
        with standard rehabilitation training (SR, 3 months) in obese/overweight diabetic patients&#xD;
        with cardiovascular (CV) complications. The study will enroll in parallel a control group&#xD;
        that can access only generic cardiological counseling with a prescription for unsupervised&#xD;
        home exercise.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>This is a single-center, randomized controlled intervention study with three parallel arms (NW=Nordic Walking, SR=standard rehabilitation and CG=control group), open label.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Six Minute Walking Test (6MWT) distance in meters</measure>
      <time_frame>An average of 6 months</time_frame>
      <description>Assess distance in meters, determined by the Six Minute Walking Test (6MWT) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adherence</measure>
      <time_frame>Through intervention completion, an average of 3 months</time_frame>
      <description>Monitoring of adherence to the intervention considering the number of sessions of the treatment [Nordic Walking (NW); Standard Rehabilitation (SR) or Control Group (CG) intervention] attended during the 3 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>An average of 6 months</time_frame>
      <description>To verify the effectiveness of the interventions in reducing the levels of anxiety as detected by The Generalized Anxiety Disorder Scale (GAD-7) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2). The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety; Score 5-9: Mild Anxiety; Score 10-14: Moderate Anxiety; Score greater than 15: Severe Anxiety (Spitzer et al., 2006).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>An average of 6 months</time_frame>
      <description>To verify the effectiveness of the interventions in reducing the levels of depression as detected by The Patient Health Questionnaire-9 (PHQ-9) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2). Regarding severity, PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms (Kroenke and Spitzer, 2002).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Short Form Health Survey 12 (SF-12)</measure>
      <time_frame>An average of 12 months</time_frame>
      <description>To verify the effectiveness of the interventions in improving the levels of Quality of Life detected thanks to The Short Form Health Survey 12 (SF-12) (Ware et al., 2000) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), after 3 months of observation (T2), 12 months (T3).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variation in Body Mass Index (BMI)</measure>
      <time_frame>An average of 12 months</time_frame>
      <description>To verify the effectiveness of the interventions in improving the Body Mass Index (BMI) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), after 3 months of observation (T2), 12 months (T3).&#xD;
  An improvement of at least 10% in BMI is considered significant.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak Oxygen Uptake (VO2)</measure>
      <time_frame>An average of 6 months</time_frame>
      <description>Assess increasing in Peak Oxygen Uptake (VO2) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups group at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">105</enrollment>
    <condition>Cardiovascular Diseases</condition>
    <condition>Diabete Type 2</condition>
    <condition>Overweight and Obesity</condition>
    <arm_group>
      <arm_group_label>Nordic Walking (NW)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nordic walking is a form of physical activity that originated in Finland and has gained popularity worldwide. It involves walking with the use of specially designed poles that resemble ski poles. This activity engages both the upper and lower body, making it a full-body workout. In summary, Nordic walking offers several benefits for cardiovascular individuals with Type II diabetes and those who are obese or overweight. These benefits include improved heart and lung function, better blood glucose control, weight management, low joint impact, muscle strengthening, improved balance and posture, and social engagement. However, it is important to consult with a healthcare provider before starting any new exercise program to ensure it is safe and suitable for individual health conditions and goals. Regular monitoring and adjustments by healthcare professionals can help optimize the benefits and ensure ongoing progress.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Rehabilitation (SR)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A standard rehabilitation program for cardiovascular individuals with Type II diabetes and obesity/overweight typically involves a combination of cardiovascular exercise, strength training, and education on lifestyle modifications. The program is prescribed by a cardiologist and supervised by physiotherapists or exercise specialists. It includes an initial assessment to determine exercise parameters, cardiovascular exercise to improve heart function and manage blood glucose levels, strength training to increase muscle mass and aid in weight management, education on nutrition and lifestyle modifications, and progress tracking and monitoring to optimize outcomes. These programs provide benefits such as improved cardiovascular fitness, better blood glucose control, weight management, enhanced muscle strength, and overall well-being.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group (CG)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Cardiological counseling for cardiovascular individuals with Type II diabetes and obesity/overweight often includes recommendations for unsupervised aerobic physical activity. This type of counseling typically involves a cardiologist providing guidelines and recommendations for safe and effective exercise routines. In summary, it involves an initial assessment to determine exercise capacity and precautions. The cardiologist prescribes specific guidelines for unsupervised aerobic physical activity, including the type, frequency, intensity, and duration of exercise sessions. Safety considerations are provided. The benefits of unsupervised aerobic physical activity include improved cardiovascular health, enhanced blood glucose control, weight management, psychological well-being, and increased energy and stamina.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nordic Walking (NW)</intervention_name>
      <description>The experimental group will carry out NW sessions three times a week for 12 weeks, supervised by a NW instructor and under the control of a cardiologist. The duration of each NW session will initially be 90 minutes: 10 minutes of warm-up, 60 of NW, and 15 minutes of cool-down. The intensity of the course will be gradually increased each week, starting at 70 to 85% of the heart rate (HR) reserve. It will also receive indications relating to a balanced diet plan which proposes a moderate (300-400 KCal) daily caloric restriction concerning the usual caloric expenditure, estimated based on initial body composition measurements.</description>
      <arm_group_label>Nordic Walking (NW)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard Rehabilitation (SR)</intervention_name>
      <description>The second group will follow a standard rehabilitation program with an initial cardiological prescription and supervised by physiotherapists, carried out 5 days a week with sessions lasting 40 minutes, including 5 minutes of warm-up up), 30 min of aerobic physical activity on a conveyor belt or cycle ergometer and 5 minutes of cooling down (cool down). The intensity of your aerobic activity will gradually increase each week, starting at 70 to 85% of HR reserve. It will also receive indications relating to a balanced diet plan which proposes a moderate (300-400 KCal) daily caloric restriction concerning the usual caloric expenditure, estimated based on initial body composition measurements.</description>
      <arm_group_label>Standard Rehabilitation (SR)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cardiological Counselling (CC)</intervention_name>
      <description>The third group of participants will receive cardiological counselling with indications of unsupervised aerobic physical activity. The group will also receive indications relating to a balanced diet plan which proposes a moderate (300-400 KCal) daily caloric restriction concerning the usual caloric expenditure, estimated based on initial body composition measurements.</description>
      <arm_group_label>Control Group (CG)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - overweight [Body Mass Index (BMI) ≥ 27 kg/m2] or obese (BMI ≥30 kg/m2) adult patients&#xD;
          with diabetes mellitus and with a recent cardiovascular event and/or coronary&#xD;
          revascularization in the previous three months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  inability to walk independently and constantly;&#xD;
  &#xD;
            -  acute joint or spine pathologies that make movement impossible;&#xD;
  &#xD;
            -  the presence of dementia as approved by consultation of the patient's medical record&#xD;
               and/or administration of the Montreal Cognitive Assessment (MOCA) test ≤ 15.5&#xD;
               (Nasreddine et al., 2005);&#xD;
  &#xD;
            -  chemotherapy 6 months before surgery;&#xD;
  &#xD;
            -  advanced renal failure;&#xD;
  &#xD;
            -  acute cardiovascular event &lt; 3 months (unstable angina, AMI with FE &lt;40%, arrhythmias,&#xD;
               valvular disease, intracerebral/subdural haemorrhage, uncontrolled AI);&#xD;
  &#xD;
            -  home oxygen therapy and Non-Invasive Ventilation (NIV) [excluding Continuous Positive&#xD;
               Airway Pressure (CPAP)].&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anna Torri, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nuccia Morici, MD, Ph.D.</last_name>
      <phone>3206359064</phone>
      <phone_ext>0039</phone_ext>
      <email>nmorici@dongnocchi.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>IRCCS Fondazione Don Carlo Gnocchi</name>
        <address>
          <city>Milan</city>
          <zip>20148</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Anna Torri, MD</last_name>
        <phone>3477408748</phone>
        <phone_ext>0039</phone_ext>
        <email>atorri@dongnocchi.it</email>
      </contact>
      <contact_backup>
        <last_name>Eleonora Volpato, Psy.D, Ph.D.</last_name>
        <phone>3293782692</phone>
        <phone_ext>0039</phone_ext>
        <email>evolpato@dongnocchi.it</email>
      </contact_backup>
      <investigator>
        <last_name>Anna Torri, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <citation>Mohammad NS, Nazli R, Zafar H, Fatima S. Effects of lipid based Multiple Micronutrients Supplement on the birth outcome of underweight pre-eclamptic women: A randomized clinical trial. Pak J Med Sci. 2022 Jan-Feb;38(1):219-226. doi: 10.12669/pjms.38.1.4396.</citation>
      <PMID>35035429</PMID>
    </reference>
    <reference>
      <citation>Conroy DE, Maher JP, Elavsky S, Hyde AL, Doerksen SE. Sedentary behavior as a daily process regulated by habits and intentions. Health Psychol. 2013 Nov;32(11):1149-57. doi: 10.1037/a0031629. Epub 2013 Mar 11.</citation>
      <PMID>23477579</PMID>
    </reference>
    <reference>
      <citation>Despres JP, Carpentier AC, Tchernof A, Neeland IJ, Poirier P. Management of Obesity in Cardiovascular Practice: JACC Focus Seminar. J Am Coll Cardiol. 2021 Aug 3;78(5):513-531. doi: 10.1016/j.jacc.2021.05.035.</citation>
      <PMID>34325840</PMID>
    </reference>
    <reference>
      <citation>Elavsky S, McAuley E. Physical activity and mental health outcomes during menopause: a randomized controlled trial. Ann Behav Med. 2007 Apr;33(2):132-42. doi: 10.1007/BF02879894.</citation>
      <PMID>17447865</PMID>
    </reference>
    <reference>
      <citation>Gholami M, Larijani B, Zahedi Z, Mahmoudian F, Bahrami S, Omran SP, Saadatian Z, Hasani-Ranjbar S, Taslimi R, Bastami M, Amoli MM. Inflammation related miRNAs as an important player between obesity and cancers. J Diabetes Metab Disord. 2019 Nov 26;18(2):675-692. doi: 10.1007/s40200-019-00459-2. eCollection 2019 Dec.</citation>
      <PMID>31890692</PMID>
    </reference>
    <reference>
      <citation>Henning RJ. Obesity and obesity-induced inflammatory disease contribute to atherosclerosis: a review of the pathophysiology and treatment of obesity. Am J Cardiovasc Dis. 2021 Aug 15;11(4):504-529. eCollection 2021.</citation>
      <PMID>34548951</PMID>
    </reference>
    <reference>
      <citation>La Sala L, Pontiroli AE. Prevention of Diabetes and Cardiovascular Disease in Obesity. Int J Mol Sci. 2020 Oct 31;21(21):8178. doi: 10.3390/ijms21218178.</citation>
      <PMID>33142938</PMID>
    </reference>
    <reference>
      <citation>Ipp E, Genter P, Childress K. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2017 Mar 2;376(9):890-1. doi: 10.1056/NEJMc1615712. No abstract available.</citation>
      <PMID>28252263</PMID>
    </reference>
    <reference>
      <citation>Baek S, Ha Y, Park HW. Accuracy of Wearable Devices for Measuring Heart Rate During Conventional and Nordic Walking. PM R. 2021 Apr;13(4):379-386. doi: 10.1002/pmrj.12424. Epub 2020 Jul 17.</citation>
      <PMID>32449291</PMID>
    </reference>
    <reference>
      <citation>Graffigna G, Barello S, Bonanomi A, Lozza E, Hibbard J. Measuring patient activation in Italy: Translation, adaptation and validation of the Italian version of the patient activation measure 13 (PAM13-I). BMC Med Inform Decis Mak. 2015 Dec 23;15:109. doi: 10.1186/s12911-015-0232-9.</citation>
      <PMID>26699852</PMID>
    </reference>
    <reference>
      <citation>Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.</citation>
      <PMID>11556941</PMID>
    </reference>
    <reference>
      <citation>Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.</citation>
      <PMID>15817019</PMID>
    </reference>
    <reference>
      <citation>Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.</citation>
      <PMID>16717171</PMID>
    </reference>
    <reference>
      <citation>Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.</citation>
      <PMID>8628042</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Don Carlo Gnocchi Onlus</investigator_affiliation>
      <investigator_full_name>Nuccia Morici</investigator_full_name>
      <investigator_title>MD, Ph.D.</investigator_title>
    </responsible_party>
    <keyword>Nordic Walking (NW)</keyword>
    <keyword>cardiovascular disease</keyword>
    <keyword>diabetes Type II</keyword>
    <keyword>overweight</keyword>
    <keyword>obesity</keyword>
    <keyword>Six Minute Walking Test (6MWT)</keyword>
    <keyword>adherence</keyword>
    <keyword>rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Overweight</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05987410
  org study id: 27/2023/CE_FdG/FC/SA
  nct id: NCT05987410
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Nordic Walking (NW) is a biomechanically correct walking technique that originated in Finland
        in the 1930s as an off-season training method for cross-country skiers. In the NW, the use of
        special sticks is combined with "conventional" walking: this involves a greater caloric
        expenditure, with an energy consumption higher by 20-30% compared to walking without sticks,
        and also toning of the upper part of the body, in particular triceps, shoulders and back, and
        the involvement of about 90% of the body's muscles, while maintaining a reduced load on
        ligaments and joints (Baek & Ha, 2021). The NW acts simultaneously and effectively on
        different components of fitness: coordination, endurance, strength, and mobility. It does not
        require sudden accelerations and is based on a technique that is easy to learn (with the help
        of an instructor), especially as regards maintaining correct posture. Finally, in addition to
        the cardiovascular benefits, NW has also been shown to effectively reduce the risk of falls
        in the elderly. The study is a single-center, randomized controlled trial (RCT), with a
        three-parallel-arm design, open-label. The primary objective is to evaluate the efficacy (in
        terms of cardiovascular performance), safety, and adherence (in terms of dropout rate) to the
        exercise prescription after 6 and 12 months follow-up of a 3-month NW intervention compared
        with standard rehabilitation training (SR, 3 months) in obese/overweight diabetic patients
        with cardiovascular (CV) complications. The study will enroll in parallel a control group
        that can access only generic cardiological counseling with a prescription for unsupervised
        home exercise.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a single-center, randomized controlled intervention study with three parallel arms (NW=Nordic Walking, SR=standard rehabilitation and CG=control group), open label.
  primary purpose: Other
  masking: None (Open Label)
  measure: Six Minute Walking Test (6MWT) distance in meters
  time frame: An average of 6 months
  description: Assess distance in meters, determined by the Six Minute Walking Test (6MWT) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2)
  measure: Adherence
  time frame: Through intervention completion, an average of 3 months
  description: Monitoring of adherence to the intervention considering the number of sessions of the treatment [Nordic Walking (NW); Standard Rehabilitation (SR) or Control Group (CG) intervention] attended during the 3 months.
  measure: Anxiety
  time frame: An average of 6 months
  description: To verify the effectiveness of the interventions in reducing the levels of anxiety as detected by The Generalized Anxiety Disorder Scale (GAD-7) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2). The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety; Score 5-9: Mild Anxiety; Score 10-14: Moderate Anxiety; Score greater than 15: Severe Anxiety (Spitzer et al., 2006).
  measure: Depression
  time frame: An average of 6 months
  description: To verify the effectiveness of the interventions in reducing the levels of depression as detected by The Patient Health Questionnaire-9 (PHQ-9) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2). Regarding severity, PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms (Kroenke and Spitzer, 2002).
  measure: The Short Form Health Survey 12 (SF-12)
  time frame: An average of 12 months
  description: To verify the effectiveness of the interventions in improving the levels of Quality of Life detected thanks to The Short Form Health Survey 12 (SF-12) (Ware et al., 2000) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), after 3 months of observation (T2), 12 months (T3).
  measure: Variation in Body Mass Index (BMI)
  time frame: An average of 12 months
  description: To verify the effectiveness of the interventions in improving the Body Mass Index (BMI) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), after 3 months of observation (T2), 12 months (T3).
  An improvement of at least 10% in BMI is considered significant.
  measure: Peak Oxygen Uptake (VO2)
  time frame: An average of 6 months
  description: Assess increasing in Peak Oxygen Uptake (VO2) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups group at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2)
  arm group label: Nordic Walking (NW)
  arm group type: Experimental
  description: Nordic walking is a form of physical activity that originated in Finland and has gained popularity worldwide. It involves walking with the use of specially designed poles that resemble ski poles. This activity engages both the upper and lower body, making it a full-body workout. In summary, Nordic walking offers several benefits for cardiovascular individuals with Type II diabetes and those who are obese or overweight. These benefits include improved heart and lung function, better blood glucose control, weight management, low joint impact, muscle strengthening, improved balance and posture, and social engagement. However, it is important to consult with a healthcare provider before starting any new exercise program to ensure it is safe and suitable for individual health conditions and goals. Regular monitoring and adjustments by healthcare professionals can help optimize the benefits and ensure ongoing progress.
  arm group label: Standard Rehabilitation (SR)
  arm group type: Active Comparator
  description: A standard rehabilitation program for cardiovascular individuals with Type II diabetes and obesity/overweight typically involves a combination of cardiovascular exercise, strength training, and education on lifestyle modifications. The program is prescribed by a cardiologist and supervised by physiotherapists or exercise specialists. It includes an initial assessment to determine exercise parameters, cardiovascular exercise to improve heart function and manage blood glucose levels, strength training to increase muscle mass and aid in weight management, education on nutrition and lifestyle modifications, and progress tracking and monitoring to optimize outcomes. These programs provide benefits such as improved cardiovascular fitness, better blood glucose control, weight management, enhanced muscle strength, and overall well-being.
  arm group label: Control Group (CG)
  arm group type: Other
  description: Cardiological counseling for cardiovascular individuals with Type II diabetes and obesity/overweight often includes recommendations for unsupervised aerobic physical activity. This type of counseling typically involves a cardiologist providing guidelines and recommendations for safe and effective exercise routines. In summary, it involves an initial assessment to determine exercise capacity and precautions. The cardiologist prescribes specific guidelines for unsupervised aerobic physical activity, including the type, frequency, intensity, and duration of exercise sessions. Safety considerations are provided. The benefits of unsupervised aerobic physical activity include improved cardiovascular health, enhanced blood glucose control, weight management, psychological well-being, and increased energy and stamina.
  intervention type: Other
  intervention name: Nordic Walking (NW)
  description: The experimental group will carry out NW sessions three times a week for 12 weeks, supervised by a NW instructor and under the control of a cardiologist. The duration of each NW session will initially be 90 minutes: 10 minutes of warm-up, 60 of NW, and 15 minutes of cool-down. The intensity of the course will be gradually increased each week, starting at 70 to 85% of the heart rate (HR) reserve. It will also receive indications relating to a balanced diet plan which proposes a moderate (300-400 KCal) daily caloric restriction concerning the usual caloric expenditure, estimated based on initial body composition measurements.
  arm group label: Nordic Walking (NW)
  intervention type: Other
  intervention name: Standard Rehabilitation (SR)
  description: The second group will follow a standard rehabilitation program with an initial cardiological prescription and supervised by physiotherapists, carried out 5 days a week with sessions lasting 40 minutes, including 5 minutes of warm-up up), 30 min of aerobic physical activity on a conveyor belt or cycle ergometer and 5 minutes of cooling down (cool down). The intensity of your aerobic activity will gradually increase each week, starting at 70 to 85% of HR reserve. It will also receive indications relating to a balanced diet plan which proposes a moderate (300-400 KCal) daily caloric restriction concerning the usual caloric expenditure, estimated based on initial body composition measurements.
  arm group label: Standard Rehabilitation (SR)
  intervention type: Other
  intervention name: Cardiological Counselling (CC)
  description: The third group of participants will receive cardiological counselling with indications of unsupervised aerobic physical activity. The group will also receive indications relating to a balanced diet plan which proposes a moderate (300-400 KCal) daily caloric restriction concerning the usual caloric expenditure, estimated based on initial body composition measurements.
  arm group label: Control Group (CG)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Anna Torri, MD
  role: Principal Investigator
  affiliation: IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
  last name: Nuccia Morici, MD, Ph.D.
  phone: 3206359064
  phone ext: 0039
  email: nmorici@dongnocchi.it
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Italy
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  PMID: 8628042
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Don Carlo Gnocchi Onlus
  investigator full name: Nuccia Morici
  investigator title: MD, Ph.D.
  mesh term: Cardiovascular Diseases
  mesh term: Overweight
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No