<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/NCT03810846</url>
  </required_header>
  <id_info>
    <org_study_id>ISPUP-RMFIFA2018</org_study_id>
    <nct_id>NCT03810846</nct_id>
  </id_info>
  <brief_title>Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes</brief_title>
  <official_title>Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federação Portuguesa de Futebol, Portugal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Administração Regional de Saúde do Norte, Portugal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fédération Internationale de Football Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade do Porto</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>
      Our main challenge is to develop a novel physical activity intervention to promote exercise&#xD;
      participation sustainability and effective health benefits in type 2 diabetes (T2D)&#xD;
      population with minimum health risks. The relevance of this study is supported by four&#xD;
      cornerstones: 1) The Portuguese love football and there seems to be a major potential in the&#xD;
      implementation of football practice as part of the prevention and treatment of&#xD;
      noncommunicable diseases for the middle-aged and elderly Portuguese population; 2) no studies&#xD;
      have assessed the feasibility and safety of a walking football exercise program for&#xD;
      middle-age and older patients with T2D; 3) the proposed investigation relies on robust&#xD;
      methodology; 4) this intervention can have further sustainability with the enrollment of&#xD;
      football clubs and primary health care units.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This work will be a quasi-experimental study where we aim to test the feasibility and safety&#xD;
      of walking football in patients with T2D. The recruitment of participants will be held in&#xD;
      primary health care units by Family Medicine medical doctors. All participants will receive&#xD;
      instructions to maintain daily-life routines (lifestyle-related physical activity and dietary&#xD;
      pattern), and to continue with usual care (diabetes consultations on primary health care&#xD;
      units and pharmacological regimen) along the studies duration. All participants will receive&#xD;
      basic sports material (sports bag, T-shirt, and sports shoes). Participants will be organized&#xD;
      in two teams of 20 players. Each team will have 60-min walking football exercise sessions&#xD;
      three times per week (non-consecutive days), during three months (36 sessions). Different&#xD;
      walking football exercise strategies will be developed according to participants' motor&#xD;
      skills and tested with dose-escalated intensity for its safety (acute effects on capillary&#xD;
      glycaemia, blood pressure, foot impact, exercise-related injuries and adverse events) and&#xD;
      enjoyment. Exercise intensity will range between light to vigorous. No submaximal or maximal&#xD;
      exercises will be tested. Cumulative short-term effects will also be analyzed along the three&#xD;
      months through pre- and post-study evaluations. Exercise sessions will be conducted on a&#xD;
      sports hall (indoor court) by a football coach and supervised by an exercise physiologist and&#xD;
      a nurse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise intensity - subjective internal load</measure>
    <time_frame>Through 3 months</time_frame>
    <description>OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exercise intensity - objective internal load</measure>
    <time_frame>Through 3 months</time_frame>
    <description>Heart rate during exercise</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exercise intensity - external load</measure>
    <time_frame>Through 3 months</time_frame>
    <description>Distance (km) assessed using GPS tracking during exercise</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute glycemic effect</measure>
    <time_frame>Change between before and immediately after each exercise session</time_frame>
    <description>Acute change in capillary blood glucose with exercise sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute systolic blood pressure effect</measure>
    <time_frame>Change between before and immediately after each exercise session</time_frame>
    <description>Acute change in systolic blood pressure with exercise sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute diastolic blood pressure effect</measure>
    <time_frame>Change between before and immediately after each exercise session</time_frame>
    <description>Acute change in diastolic blood pressure with exercise sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of falls</measure>
    <time_frame>Through 3 months</time_frame>
    <description>Number of falls during the exercise program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of foot injuries</measure>
    <time_frame>Through 3 months</time_frame>
    <description>Number of reported foot injuries during the exercise program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of musculoskeletal injuries</measure>
    <time_frame>Through 3 months</time_frame>
    <description>Number of reported musculoskeletal injuries during the exercise program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Enjoyment</measure>
    <time_frame>Through 3 months</time_frame>
    <description>Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Glycated hemoglobin (venous blood analysis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood lipid profile</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Total cholesterol (venous blood analysis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical systolic blood pressure</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Resting systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical diastolic blood pressure</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Resting diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Waist circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Body fat (bioelectrical impedance analysis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body lean mass</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Body lean mass (bioelectrical impedance analysis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Agility/balance</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Timed Up and Go Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Habitual physical activity</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Global Physical Activity Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food pattern</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>24h-food recall analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive state</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Number of medications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Walking football exercise program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking football exercise program</intervention_name>
    <description>Participants will be organized in two teams of 20 players. Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions). Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety and enjoyment. Exercise intensity will range between light to vigorous. No submaximal or maximal exercises will be tested. Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of type 2 diabetes for at least 12 months;&#xD;
&#xD;
          -  glycated hemoglobin bellow 10 %;&#xD;
&#xD;
          -  not having started insulin therapy in the previous six months;&#xD;
&#xD;
          -  not having started therapy with sulfonylureas in the previous six months;&#xD;
&#xD;
          -  major complications of diabetes screened and controlled (diabetic retinopathy,&#xD;
             diabetic nephropathy and diabetic foot);&#xD;
&#xD;
          -  no symptoms of coronary artery disease;&#xD;
&#xD;
          -  no cardiovascular, respiratory and musculoskeletal contraindications to exercise;&#xD;
&#xD;
          -  not under cancer treatment (radiotherapy or intravenous chemotherapy);&#xD;
&#xD;
          -  without limitations in gait or balance;&#xD;
&#xD;
          -  independent living in the community;&#xD;
&#xD;
          -  not engaged in supervised exercise;&#xD;
&#xD;
          -  non-smokers at least for 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiological stress test with cardiac or hemodynamic problems&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Romeu Mendes, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>EPIUnit - Instituto de Saúde Pública, Universidade do Porto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Saúde Pública da Universidade do Porto</name>
      <address>
        <city>Porto</city>
        <zip>4050-600</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <reference>
    <citation>Barbosa A, Brito J, Costa J, Ramos E, Firmino-Machado J, Seabra A, Figueiredo P, Sá MJ, Lunet N, Mendes R. SWEET-FOOTBALL: Development of an evidence-based walking football program for middle-aged and older patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 32.</citation>
  </reference>
  <results_reference>
    <citation>Barbosa A, Brito J, Sá MJ, Puga F, Firmino-Machado J, Seabra A, Figueiredo P, Ramos E, Lunet N, Mendes R. Adherence and enjoyment of a walking-football program for patients with type 2 diabetes: SWEET-FOOTBALL Project. In: Bunc V, Tsolakidis E, editors. Book of Abstracts of the 24th Annual Congress of the European College of Sport Science. Prague: ECSS; 2019. p. 120-1.</citation>
  </results_reference>
  <results_reference>
    <citation>Rago V, Brito J, Costa J, Barbosa A, Figueiredo P, Seabra A, Travassos B, Mendes R. Activity profile during walking football training sessions in patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern University; 2019. p. 41.</citation>
  </results_reference>
  <results_reference>
    <citation>Costa J, Brito J, Barbosa A, Figueiredo P, Seabra A, Sá MJ, Firmino-Machado J, Ramos E, Mendes R. Nocturnal cardiac autonomic activity in patients with type 2 diabetes engaged in a walking football programme. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 39.</citation>
  </results_reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade do Porto</investigator_affiliation>
    <investigator_full_name>Romeu Mendes</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Football</keyword>
  <keyword>Walking Football</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Primary Health Care</keyword>
  <keyword>Feasibility</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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>


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/NCT03810846
org study id: ISPUP-RMFIFA2018
nct id: NCT03810846
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our main challenge is to develop a novel physical activity intervention to promote exercise
      participation sustainability and effective health benefits in type 2 diabetes (T2D)
      population with minimum health risks. The relevance of this study is supported by four
      cornerstones: 1) The Portuguese love football and there seems to be a major potential in the
      implementation of football practice as part of the prevention and treatment of
      noncommunicable diseases for the middle-aged and elderly Portuguese population; 2) no studies
      have assessed the feasibility and safety of a walking football exercise program for
      middle-age and older patients with T2D; 3) the proposed investigation relies on robust
      methodology; 4) this intervention can have further sustainability with the enrollment of
      football clubs and primary health care units.
This work will be a quasi-experimental study where we aim to test the feasibility and safety
      of walking football in patients with T2D. The recruitment of participants will be held in
      primary health care units by Family Medicine medical doctors. All participants will receive
      instructions to maintain daily-life routines (lifestyle-related physical activity and dietary
      pattern), and to continue with usual care (diabetes consultations on primary health care
      units and pharmacological regimen) along the studies duration. All participants will receive
      basic sports material (sports bag, T-shirt, and sports shoes). Participants will be organized
      in two teams of 20 players. Each team will have 60-min walking football exercise sessions
      three times per week (non-consecutive days), during three months (36 sessions). Different
      walking football exercise strategies will be developed according to participants' motor
      skills and tested with dose-escalated intensity for its safety (acute effects on capillary
      glycaemia, blood pressure, foot impact, exercise-related injuries and adverse events) and
      enjoyment. Exercise intensity will range between light to vigorous. No submaximal or maximal
      exercises will be tested. Cumulative short-term effects will also be analyzed along the three
      months through pre- and post-study evaluations. Exercise sessions will be conducted on a
      sports hall (indoor court) by a football coach and supervised by an exercise physiologist and
      a nurse.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Exercise intensity - subjective internal load
time frame: Through 3 months
description: OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)
measure: Exercise intensity - objective internal load
time frame: Through 3 months
description: Heart rate during exercise
measure: Exercise intensity - external load
time frame: Through 3 months
description: Distance (km) assessed using GPS tracking during exercise
measure: Acute glycemic effect
time frame: Change between before and immediately after each exercise session
description: Acute change in capillary blood glucose with exercise sessions
measure: Acute systolic blood pressure effect
time frame: Change between before and immediately after each exercise session
description: Acute change in systolic blood pressure with exercise sessions
measure: Acute diastolic blood pressure effect
time frame: Change between before and immediately after each exercise session
description: Acute change in diastolic blood pressure with exercise sessions
measure: Incidence of falls
time frame: Through 3 months
description: Number of falls during the exercise program
measure: Incidence of foot injuries
time frame: Through 3 months
description: Number of reported foot injuries during the exercise program
measure: Incidence of musculoskeletal injuries
time frame: Through 3 months
description: Number of reported musculoskeletal injuries during the exercise program
measure: Rate of Enjoyment
time frame: Through 3 months
description: Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)
measure: Glycemic control
time frame: Change from baseline to 3 months
description: Glycated hemoglobin (venous blood analysis)
measure: Blood lipid profile
time frame: Change from baseline to 3 months
description: Total cholesterol (venous blood analysis)
measure: Clinical systolic blood pressure
time frame: Change from baseline to 3 months
description: Resting systolic blood pressure
measure: Clinical diastolic blood pressure
time frame: Change from baseline to 3 months
description: Resting diastolic blood pressure
measure: Body mass index
time frame: Change from baseline to 3 months
description: Body mass index
measure: Waist circumference
time frame: Change from baseline to 3 months
description: Waist circumference
measure: Body fat
time frame: Change from baseline to 3 months
description: Body fat (bioelectrical impedance analysis)
measure: Body lean mass
time frame: Change from baseline to 3 months
description: Body lean mass (bioelectrical impedance analysis)
measure: Agility/balance
time frame: Change from baseline to 3 months
description: Timed Up and Go Test
measure: Habitual physical activity
time frame: Change from baseline to 3 months
description: Global Physical Activity Questionnaire
measure: Food pattern
time frame: Change from baseline to 3 months
description: 24h-food recall analysis
measure: Cognitive state
time frame: Change from baseline to 3 months
description: Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)
measure: Health-related quality of life
time frame: Change from baseline to 3 months
description: EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)
measure: Medication
time frame: Change from baseline to 3 months
description: Number of medications
arm group label: Exercise
arm group type: Experimental
description: Walking football exercise program
intervention type: Behavioral
intervention name: Walking football exercise program
description: Participants will be organized in two teams of 20 players. Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions). Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety and enjoyment. Exercise intensity will range between light to vigorous. No submaximal or maximal exercises will be tested. Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.
arm group label: Exercise
criteria: 
gender: Male
gender based: Yes
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
last name: Romeu Mendes, MD, PhD
role: Principal Investigator
affiliation: EPIUnit - Instituto de Saúde Pública, Universidade do Porto
facility: 
country: Portugal
citation: Barbosa A, Brito J, Costa J, Ramos E, Firmino-Machado J, Seabra A, Figueiredo P, Sá MJ, Lunet N, Mendes R. SWEET-FOOTBALL: Development of an evidence-based walking football program for middle-aged and older patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 32.
citation: Barbosa A, Brito J, Sá MJ, Puga F, Firmino-Machado J, Seabra A, Figueiredo P, Ramos E, Lunet N, Mendes R. Adherence and enjoyment of a walking-football program for patients with type 2 diabetes: SWEET-FOOTBALL Project. In: Bunc V, Tsolakidis E, editors. Book of Abstracts of the 24th Annual Congress of the European College of Sport Science. Prague: ECSS; 2019. p. 120-1.
citation: Rago V, Brito J, Costa J, Barbosa A, Figueiredo P, Seabra A, Travassos B, Mendes R. Activity profile during walking football training sessions in patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern University; 2019. p. 41.
citation: Costa J, Brito J, Barbosa A, Figueiredo P, Seabra A, Sá MJ, Firmino-Machado J, Ramos E, Mendes R. Nocturnal cardiac autonomic activity in patients with type 2 diabetes engaged in a walking football programme. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 39.
responsible party type: Principal Investigator
investigator affiliation: Universidade do Porto
investigator full name: Romeu Mendes
investigator title: Researcher
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No