<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/NCT04431167</url>
  </required_header>
  <id_info>
    <org_study_id>Living well with lupus Study</org_study_id>
    <nct_id>NCT04431167</nct_id>
  </id_info>
  <brief_title>Healthy Lifestyle Intervention in Patients With Systemic Lupus Erythematosus: The Living Well With Lupus Study</brief_title>
  <official_title>Healthy Lifestyle Intervention in Patients With Systemic Lupus Erythematosus With High Cardiovascular Risk: The Living Well With Lupus Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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 research program aims to investigate the clinical, physiological, metabolic and&#xD;
      molecular effects of lifestyle change in patients with systemic lupus erythematosus with high&#xD;
      cardiovascular risk. This 6-month parallel-group randomized controlled trial aims to&#xD;
      investigate the feasibility and efficacy of a newly developed lifestyle change intervention -&#xD;
      through recommendations for structured and unstructured physical activity and healthy eating&#xD;
      - on increasing physical activity level and improving eating habits. Potential effects of the&#xD;
      intervention on cardiovascular and cardiometabolic risk factors, health-related quality of&#xD;
      life, symptoms of anxiety and depression, sleep quality and immune function will be&#xD;
      investigated. Gold-standard techniques and a variety of analyses will be performed to access&#xD;
      the potential mechanisms involved in response to this intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</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>Experimental group and no intervention group (usual care group)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The researcher responsible for performing the blood flow measurement will be blinded to the allocation of groups</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Risk cardiovascular score</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by measures of five standard variables (HDL cholesterol, triglycerides, fasting blood glucose, waist circumference and blood pressure - average of systolic and diastolic blood pressures). Z-score = [(50 - HDL cholesterol)/sd + (triglycerides - 150)/ sd] + [(fasting blood glucose - 100)/ sd] + [(waist circumference - 88)/ sd] + [(blood pressure - 115)/ sd]. Higher score values represent higher risk. *sd: standard deviation. Higher Z-score represent higher risk.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by weight (kg) and height (m) that will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference (cm)</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by measuring tape positioned at the midpoint between the last floating vertebra and the iliac crest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by blood sample analysis and combined to determine lipid profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by oral glucose tolerance test (OGTT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and Diastolic blood pressure</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by auscultatory method with mercury sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by thigh-mounted accelerometer (ActivPAL™ micro)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food consumption</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by three 24-hour food recall in non-consecutive days (being one of the days on the weekend)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visceral fat</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by tomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak oxygen consumption, as assessed by a cardiopulmonary exercise test</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by flow-mediated vasodilatation (FMD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease activity</measure>
    <time_frame>6 months</time_frame>
    <description>The activity of the disease, which will be impaired by safety, will be assessed by the presence of anti-dsDNA, using the ELISA technique and confirmation by indirect immunofluorescence in Crithidia luciliae and assessed by the questionnaire Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2000). Total score ranges from 0 to 105. Higher scores represent higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Damage index</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by Systemic Lupus International Collaborating Clinics/ American College of Rheumatology - Damage Index. Total score range from 0 (no damage) to 46 (maximum damage).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global health status</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by the Visual Analogic Scale (0 and 10 scale). Higher values represent worst global health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' perceptions of the intervention</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by focus group. A semi-structured script composed of open questions about intervention positive and negative points, barriers for physical activity practice and changes in food consumption, perceptions of health improvement or worsening (physical and psychological aspects), well-being, motivation to maintain the changes made, perspectives regarding health and disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life assesment assessed by the Short-Form Health Survey-36 (SF36) [followed by its scale information in the Description]</measure>
    <time_frame>6 months</time_frame>
    <description>maximum score is 100, with higher scores representing better life quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire ( SLEQOL) [followed by its scale information in the Description]</measure>
    <time_frame>6 months</time_frame>
    <description>score ranges from 40 to 280 with higher scores represent worst life quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning assessed by Timed-Stands</measure>
    <time_frame>6 months</time_frame>
    <description>evaluates the maximum number of stand-ups that a subject could perform from a standard height (i.e., 45 cm) armless chair within 30 s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning assessed by Timed Up-and-Go</measure>
    <time_frame>6 months</time_frame>
    <description>evaluates the time required for the subject to rise from a standard arm chair, walk towards a line drawn on the floor three meters away, turn, return, and sit back down again</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning assessed by handgrip test</measure>
    <time_frame>6 months</time_frame>
    <description>Patients will be instructed to squeeze the dynamometer as hard as possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by Fatigue Scale (FACIT). The final score can vary from 0 to 52, where higher final score representing higher level of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by sub-scale of Hospital Anxiety and Depression Scale (HADS), called HADS-A. Total score ranges from 0 to 21. Where higher final score representing higher level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by sub-scale of Hospital Anxiety and Depression Scale (HADS), called HADS-D. Total score ranges from 0 to 21. Where higher final score representing higher level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality assessed by data obtained from Actigraph (Actigraph GT3x)</measure>
    <time_frame>6 months</time_frame>
    <description>Data from actigraph will come as these measures: Total Sleep Time (hours/day), Sleep Efficiency (%), Sleep Onset Latency (min), and Wake After Sleep Onset (min), and this data will be considered to determine the sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein (PCR)</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by analysis of blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte sedimentation rate</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by analysis of blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers (blood biochemistry)</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by serum cytokines</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Living well with Lupus Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A newly developed intervention focused on promoting lifestyle change through recommendations for structured and unstructured physical activity and healthy eating.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive all regular medical care and advice healthy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Living well with Lupus</intervention_name>
    <description>The lifestyle change intervention will involve two constructs: increasing the level of physical activity and improving eating habits, each with its own specific domains and goals. It will be based on a structured program of physical exercises and selection of individualized goals in the domains of transportation, leisure and work to reduce sedentary behavior with the aim of increasing the level of physical activity, as well as establishing changes in dietary aspects, involving consumption domains, structure, behavior and eating attitude using nutritional counseling techniques.</description>
    <arm_group_label>Living well with Lupus Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between 18 and 65 years old diagnosed with systemic lupus erythematosus&#xD;
&#xD;
          -  one or more high cardiovascular risk factors&#xD;
&#xD;
          -  SLEDAI score ≤ 4&#xD;
&#xD;
          -  Treatment with prednisone at a dosage &lt;10 mg/d and treatment with hydroxychloroquine&#xD;
             in a stable dose&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  another rheumatic diseases (except for secondary Sjogren's syndrome)&#xD;
&#xD;
          -  participation in structured exercise training programs and/or prescriptive diets&#xD;
&#xD;
          -  illiterate or with diagnosed cognitive disorders or musculoskeletal impairments that&#xD;
             potentially compromise understanding and participation in the intervention&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only female participants will be eligible</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bruno Gualano, PhD</last_name>
    <phone>+551130618789</phone>
    <email>gualano@usp.br</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Bruno Gualano</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Life style</keyword>
  <keyword>Behavioral intervention</keyword>
  <keyword>Cardiovascular risk</keyword>
  <keyword>Life quality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>we can share the individual data of the participants if the request is reasonable</ipd_description>
  </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/NCT04431167
org study id: Living well with lupus Study
nct id: NCT04431167
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research program aims to investigate the clinical, physiological, metabolic and
      molecular effects of lifestyle change in patients with systemic lupus erythematosus with high
      cardiovascular risk. This 6-month parallel-group randomized controlled trial aims to
      investigate the feasibility and efficacy of a newly developed lifestyle change intervention -
      through recommendations for structured and unstructured physical activity and healthy eating
      - on increasing physical activity level and improving eating habits. Potential effects of the
      intervention on cardiovascular and cardiometabolic risk factors, health-related quality of
      life, symptoms of anxiety and depression, sleep quality and immune function will be
      investigated. Gold-standard techniques and a variety of analyses will be performed to access
      the potential mechanisms involved in response to this intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental group and no intervention group (usual care group)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The researcher responsible for performing the blood flow measurement will be blinded to the allocation of groups
measure: Risk cardiovascular score
time frame: 6 months
description: assessed by measures of five standard variables (HDL cholesterol, triglycerides, fasting blood glucose, waist circumference and blood pressure - average of systolic and diastolic blood pressures). Z-score = [(50 - HDL cholesterol)/sd + (triglycerides - 150)/ sd] + [(fasting blood glucose - 100)/ sd] + [(waist circumference - 88)/ sd] + [(blood pressure - 115)/ sd]. Higher score values represent higher risk. *sd: standard deviation. Higher Z-score represent higher risk.
measure: Body mass index (BMI)
time frame: 6 months
description: assessed by weight (kg) and height (m) that will be combined to report BMI in kg/m^2
measure: Waist circumference (cm)
time frame: 6 months
description: assessed by measuring tape positioned at the midpoint between the last floating vertebra and the iliac crest.
measure: Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides
time frame: 6 months
description: assessed by blood sample analysis and combined to determine lipid profile
measure: Insulin sensitivity
time frame: 6 months
description: assessed by oral glucose tolerance test (OGTT)
measure: Systolic and Diastolic blood pressure
time frame: 6 months
description: assessed by auscultatory method with mercury sphygmomanometer
measure: Physical activity level
time frame: 6 months
description: assessed by thigh-mounted accelerometer (ActivPAL™ micro)
measure: Food consumption
time frame: 6 months
description: assessed by three 24-hour food recall in non-consecutive days (being one of the days on the weekend)
measure: Visceral fat
time frame: 6 months
description: assessed by tomography
measure: Peak oxygen consumption, as assessed by a cardiopulmonary exercise test
time frame: 6 months
measure: Endothelial function
time frame: 6 months
description: assessed by flow-mediated vasodilatation (FMD)
measure: Disease activity
time frame: 6 months
description: The activity of the disease, which will be impaired by safety, will be assessed by the presence of anti-dsDNA, using the ELISA technique and confirmation by indirect immunofluorescence in Crithidia luciliae and assessed by the questionnaire Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2000). Total score ranges from 0 to 105. Higher scores represent higher disease activity.
measure: Damage index
time frame: 6 months
description: assessed by Systemic Lupus International Collaborating Clinics/ American College of Rheumatology - Damage Index. Total score range from 0 (no damage) to 46 (maximum damage).
measure: Global health status
time frame: 6 months
description: assessed by the Visual Analogic Scale (0 and 10 scale). Higher values represent worst global health status.
measure: Patients' perceptions of the intervention
time frame: 6 months
description: assessed by focus group. A semi-structured script composed of open questions about intervention positive and negative points, barriers for physical activity practice and changes in food consumption, perceptions of health improvement or worsening (physical and psychological aspects), well-being, motivation to maintain the changes made, perspectives regarding health and disease.
measure: Quality of Life assesment assessed by the Short-Form Health Survey-36 (SF36) [followed by its scale information in the Description]
time frame: 6 months
description: maximum score is 100, with higher scores representing better life quality
measure: Quality of Life assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire ( SLEQOL) [followed by its scale information in the Description]
time frame: 6 months
description: score ranges from 40 to 280 with higher scores represent worst life quality.
measure: Physical functioning assessed by Timed-Stands
time frame: 6 months
description: evaluates the maximum number of stand-ups that a subject could perform from a standard height (i.e., 45 cm) armless chair within 30 s
measure: Physical functioning assessed by Timed Up-and-Go
time frame: 6 months
description: evaluates the time required for the subject to rise from a standard arm chair, walk towards a line drawn on the floor three meters away, turn, return, and sit back down again
measure: Physical functioning assessed by handgrip test
time frame: 6 months
description: Patients will be instructed to squeeze the dynamometer as hard as possible
measure: Fatigue
time frame: 6 months
description: assessed by Fatigue Scale (FACIT). The final score can vary from 0 to 52, where higher final score representing higher level of fatigue.
measure: Anxiety
time frame: 6 months
description: assessed by sub-scale of Hospital Anxiety and Depression Scale (HADS), called HADS-A. Total score ranges from 0 to 21. Where higher final score representing higher level.
measure: Depression
time frame: 6 months
description: assessed by sub-scale of Hospital Anxiety and Depression Scale (HADS), called HADS-D. Total score ranges from 0 to 21. Where higher final score representing higher level.
measure: Sleep quality assessed by data obtained from Actigraph (Actigraph GT3x)
time frame: 6 months
description: Data from actigraph will come as these measures: Total Sleep Time (hours/day), Sleep Efficiency (%), Sleep Onset Latency (min), and Wake After Sleep Onset (min), and this data will be considered to determine the sleep quality.
measure: C-reactive protein (PCR)
time frame: 6 months
description: assessed by analysis of blood sample
measure: Erythrocyte sedimentation rate
time frame: 6 months
description: assessed by analysis of blood sample
measure: Inflammatory markers (blood biochemistry)
time frame: 6 months
description: assessed by serum cytokines
arm group label: Living well with Lupus Group
arm group type: Experimental
description: A newly developed intervention focused on promoting lifestyle change through recommendations for structured and unstructured physical activity and healthy eating.
arm group label: Usual Care Group
arm group type: No Intervention
description: This group will receive all regular medical care and advice healthy
intervention type: Behavioral
intervention name: Living well with Lupus
description: The lifestyle change intervention will involve two constructs: increasing the level of physical activity and improving eating habits, each with its own specific domains and goals. It will be based on a structured program of physical exercises and selection of individualized goals in the domains of transportation, leisure and work to reduce sedentary behavior with the aim of increasing the level of physical activity, as well as establishing changes in dietary aspects, involving consumption domains, structure, behavior and eating attitude using nutritional counseling techniques.
arm group label: Living well with Lupus Group
criteria: 
gender: Female
gender based: Yes
gender description: Only female participants will be eligible
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bruno Gualano, PhD
phone: +551130618789
email: gualano@usp.br
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Bruno Gualano
investigator title: Professor
mesh term: Lupus Erythematosus, Systemic
sharing ipd: Yes
ipd description: we can share the individual data of the participants if the request is reasonable