<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/NCT03754478</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00147</org_study_id>
    <nct_id>NCT03754478</nct_id>
  </id_info>
  <brief_title>Follow-Up of Fitness in Overweight Patients Treated With Physical Activity</brief_title>
  <acronym>FUFPA</acronym>
  <official_title>Follow-Up of Fitness in Overweight Patients Treated With Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hôpital intercantonal de la Broye, Estavayer-le-lac, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Lausanne</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>
      Although there is increasing evidence that low physical fitness is a risk factor for many&#xD;
      non-communicable diseases, the early identification of subjects at risk remains inadequate&#xD;
      due to the absence of clear anamnestic and clinical criteria. Defining physical fitness. For&#xD;
      the same reason, the monitoring of subjects following lifestyle interventions remains&#xD;
      suboptimal.&#xD;
&#xD;
      The aim of this study is to develop a simple field tool to non-invasively assess global&#xD;
      physical fitness in overweight patients participating to a physical activity program.&#xD;
&#xD;
      Male and female overweight subjects referred to a physical activity intervention by their&#xD;
      primary care physician will be included. Within this program, they will take part to 2 weekly&#xD;
      supervised activity sessions during which participants will be instructed by a specialist in&#xD;
      adapted physical activity, and 2-3 weekly session of unsupervised physical activity which&#xD;
      will be performed according to detailed instructions regarding intensity and duration. In&#xD;
      addition, participants will take part to teaching sessions in group of 4-6 patients,&#xD;
      addressing the effects of physical activity on metabolism, contra-indications to physical&#xD;
      activity, self-monitoring of exercise, and prevention of injuries Their physical fitness will&#xD;
      be assessed at inclusion (ie before starting the exercise program) and at the end of the&#xD;
      3-month program. This will be done by calculating a Global Fitness Score (GFS) based on&#xD;
      performances attained and cardiovascular responses observed during physical exercises (3 min&#xD;
      step test with measurement of heart rate and blood pressure, number of time subject can stand&#xD;
      from a chair within 1 min., handgrip strength measure, &quot;reach-test&quot; to assess osteo-articular&#xD;
      mobility of back and hips, balance test). Results obtained from this GFS will be compared to&#xD;
      maximal power output calculated from a submaximal spirometry at 25, 50, 75 and 100 W M.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sedentarity is a risk factor for overweight, insulin resistance and diabetes mellitus.&#xD;
      Several randomized clinical trials have shown that lifestyle interventions including exercise&#xD;
      are efficient in improving metabolic homeostasis in overweight and obese patients. This may&#xD;
      be related sedentarity being associated with low physical fitness, and to training enhancing&#xD;
      it through multiple systems effects (cardiovascular and respiratory systems, central nervous&#xD;
      system, osteo-articular system).&#xD;
&#xD;
      Although there is increasing evidence that low physical fitness is a risk factor for many&#xD;
      non-communicable diseases, the early identification of subjects at risk remains inadequate&#xD;
      due to the absence of clear anamnestic and clinical criteria. Defining physical fitness. For&#xD;
      the same reason, the monitoring of subjects following lifestyle interventions remains&#xD;
      suboptimal.&#xD;
&#xD;
      The aim of this study is to develop a simple field tool to non-invasively assess global&#xD;
      physical fitness in overweight patients participating to a physical activity program.&#xD;
&#xD;
      Eigtheen male and female subjects, aged 18-50 years, BMI &gt;27 kg/m2 referred to a physical&#xD;
      activity intervention by their primary care physician, will be included. Their physical&#xD;
      fitness will be assessed at inclusion (ie before starting the exercise program) and at the&#xD;
      end of the 3-month program.This will be done by calculating a Global Fitness Score (GFS)&#xD;
      based on performances attained and cardiovascular responses observed during 5 physical&#xD;
      exercises (3 min step test with measurement of heart rate and blood pressure, number of time&#xD;
      subject can stand from a chair within 1 min., handgrip strength measure, &quot;reach-test&quot; to&#xD;
      assess osteo-articular mobility of back and hips, balance test). Results obtained from this&#xD;
      GFS will be compared to maximal power output calculated from a submaximal spirometry at 25,&#xD;
      50, 75 and 100 W Primary outcome are: GFS (composite of a score of physical endurance, two&#xD;
      scores of muscle strength, one score of balance, and one score of osteo-articular mobility)&#xD;
      before and after 3 months of intervention.&#xD;
&#xD;
      Secondary outcomes are: physical activity questionnaire, maximal power output; maximal oxygen&#xD;
      consumption; fat oxidation; fasting metabolic profile before and after 3 months of&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">October 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Global Fitness Score before and after 3 months physical training</measure>
    <time_frame>After 3 month physical training</time_frame>
    <description>Global fitness score ranges between 0 (very low fitness) and 30 (optimal fitness). It is calculated as the sum of scores obtained with 5 simple field tests (Chester step test, score 0-10; handgrip, score 0-5; sit-and stand test, score 0-5; Sit and reach test, score 0-5; Flamingo test, score 0-5)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Exercise Training</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>overweight subjects</arm_group_label>
    <description>Overweight male and females referred to a physical activity program by their primary care physician Intervention is being included in a 3-month physical activity training program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical activity training</intervention_name>
    <description>subjects will enter a 3-month supervised physical activity program during which they will take part to supervised and unsupervised physical activity sessions. Type of physical activity will be selected among a number of available activities (aquagym, aerobics, resistance training, outdoors activities) based on individual needs and preferences); it will consist in 2 weekly supervised activity sessions during which participants will be instructed by a specialist in adapted physical activity, and 2-3 weekly session of unsupervised physical activity which will be performed according to detailed instructions regarding intensity and duration.</description>
    <arm_group_label>overweight subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Overweight subjects referred to a physical activity intervention by their primary care&#xD;
        physician&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;27 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardio-respiratory diseases&#xD;
&#xD;
          -  severe osteo-articular diseases&#xD;
&#xD;
          -  any condition associated with contra-indication to exercise.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charly Bulliard, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hopital Intercantonal de la Broye, Estavayer le-lac, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luc Tappy, MD</last_name>
    <phone>+41 21 692 55 41</phone>
    <email>luc.tappy@unil.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Virgile Lecoultre, PhD</last_name>
    <phone>+41 26 664 71 11</phone>
    <email>virgile.lecoultre@hibroye.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hopital Intercantonal de la Broye</name>
      <address>
        <city>Estavayer le lac</city>
        <state>Fribourg</state>
        <zip>1470</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Virgile Lecoultre, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne</investigator_affiliation>
    <investigator_full_name>Luc Tappy, MD</investigator_full_name>
    <investigator_title>Professor Luc Tappy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03754478
org study id: 2018-00147
nct id: NCT03754478
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although there is increasing evidence that low physical fitness is a risk factor for many
      non-communicable diseases, the early identification of subjects at risk remains inadequate
      due to the absence of clear anamnestic and clinical criteria. Defining physical fitness. For
      the same reason, the monitoring of subjects following lifestyle interventions remains
      suboptimal.

      The aim of this study is to develop a simple field tool to non-invasively assess global
      physical fitness in overweight patients participating to a physical activity program.

      Male and female overweight subjects referred to a physical activity intervention by their
      primary care physician will be included. Within this program, they will take part to 2 weekly
      supervised activity sessions during which participants will be instructed by a specialist in
      adapted physical activity, and 2-3 weekly session of unsupervised physical activity which
      will be performed according to detailed instructions regarding intensity and duration. In
      addition, participants will take part to teaching sessions in group of 4-6 patients,
      addressing the effects of physical activity on metabolism, contra-indications to physical
      activity, self-monitoring of exercise, and prevention of injuries Their physical fitness will
      be assessed at inclusion (ie before starting the exercise program) and at the end of the
      3-month program. This will be done by calculating a Global Fitness Score (GFS) based on
      performances attained and cardiovascular responses observed during physical exercises (3 min
      step test with measurement of heart rate and blood pressure, number of time subject can stand
      from a chair within 1 min., handgrip strength measure, "reach-test" to assess osteo-articular
      mobility of back and hips, balance test). Results obtained from this GFS will be compared to
      maximal power output calculated from a submaximal spirometry at 25, 50, 75 and 100 W M.
Sedentarity is a risk factor for overweight, insulin resistance and diabetes mellitus.
      Several randomized clinical trials have shown that lifestyle interventions including exercise
      are efficient in improving metabolic homeostasis in overweight and obese patients. This may
      be related sedentarity being associated with low physical fitness, and to training enhancing
      it through multiple systems effects (cardiovascular and respiratory systems, central nervous
      system, osteo-articular system).

      Although there is increasing evidence that low physical fitness is a risk factor for many
      non-communicable diseases, the early identification of subjects at risk remains inadequate
      due to the absence of clear anamnestic and clinical criteria. Defining physical fitness. For
      the same reason, the monitoring of subjects following lifestyle interventions remains
      suboptimal.

      The aim of this study is to develop a simple field tool to non-invasively assess global
      physical fitness in overweight patients participating to a physical activity program.

      Eigtheen male and female subjects, aged 18-50 years, BMI >27 kg/m2 referred to a physical
      activity intervention by their primary care physician, will be included. Their physical
      fitness will be assessed at inclusion (ie before starting the exercise program) and at the
      end of the 3-month program.This will be done by calculating a Global Fitness Score (GFS)
      based on performances attained and cardiovascular responses observed during 5 physical
      exercises (3 min step test with measurement of heart rate and blood pressure, number of time
      subject can stand from a chair within 1 min., handgrip strength measure, "reach-test" to
      assess osteo-articular mobility of back and hips, balance test). Results obtained from this
      GFS will be compared to maximal power output calculated from a submaximal spirometry at 25,
      50, 75 and 100 W Primary outcome are: GFS (composite of a score of physical endurance, two
      scores of muscle strength, one score of balance, and one score of osteo-articular mobility)
      before and after 3 months of intervention.

      Secondary outcomes are: physical activity questionnaire, maximal power output; maximal oxygen
      consumption; fat oxidation; fasting metabolic profile before and after 3 months of
      intervention.
observational model: Case-Only
time perspective: Prospective
measure: Change in Global Fitness Score before and after 3 months physical training
time frame: After 3 month physical training
description: Global fitness score ranges between 0 (very low fitness) and 30 (optimal fitness). It is calculated as the sum of scores obtained with 5 simple field tests (Chester step test, score 0-10; handgrip, score 0-5; sit-and stand test, score 0-5; Sit and reach test, score 0-5; Flamingo test, score 0-5)
arm group label: overweight subjects
description: Overweight male and females referred to a physical activity program by their primary care physician Intervention is being included in a 3-month physical activity training program
intervention type: Other
intervention name: Physical activity training
description: subjects will enter a 3-month supervised physical activity program during which they will take part to supervised and unsupervised physical activity sessions. Type of physical activity will be selected among a number of available activities (aquagym, aerobics, resistance training, outdoors activities) based on individual needs and preferences); it will consist in 2 weekly supervised activity sessions during which participants will be instructed by a specialist in adapted physical activity, and 2-3 weekly session of unsupervised physical activity which will be performed according to detailed instructions regarding intensity and duration.
arm group label: overweight subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Charly Bulliard, MD
role: Study Chair
affiliation: Hopital Intercantonal de la Broye, Estavayer le-lac, Switzerland
last name: Luc Tappy, MD
phone: +41 21 692 55 41
email: luc.tappy@unil.ch
last name: Virgile Lecoultre, PhD
phone: +41 26 664 71 11
email: virgile.lecoultre@hibroye.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne
investigator full name: Luc Tappy, MD
investigator title: Professor Luc Tappy
mesh term: Overweight
sharing ipd: Undecided