<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/NCT02188641</url>
  </required_header>
  <id_info>
    <org_study_id>alexmed12671300</org_study_id>
    <nct_id>NCT02188641</nct_id>
  </id_info>
  <brief_title>Effect of Exercise and Diet on Psoriatic Arthritis</brief_title>
  <official_title>EFFECT OF EXERCISE AND DIETARY WEIGHT LOSS ON SYMPTOMS AND SYSTEMIC INFLAMMATION IN OBESE ADULTS WITH PSORIATIC ARTHRITIS: RANDOMIZED CONTROLLED TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alexandria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psoriatic arthritis (PsA) is a particular pattern of inflammatory arthritis often seen in&#xD;
      association with psoriasis. PsA patients have a higher prevalence of comorbidities including&#xD;
      obesity, metabolic syndrome, depression and premature cardiovascular disease. There is&#xD;
      evidence that obesity is associated with PsA. A 12 month study was conducted to determine&#xD;
      whether exercise and dietary weight loss are more efficacious, either separately or in&#xD;
      combination, than standard care alone in improving symptoms and signs in obese adults with&#xD;
      PsA.&#xD;
&#xD;
      Fifty-five obese PsA patients with a body mass index (BMI) ≥30, were recruited. Patients were&#xD;
      randomized into usual lifestyle (controls), diet only, exercise only, and diet plus exercise&#xD;
      groups for 12 months. Disease activity was assessed. Blood samples collected after 12 hours&#xD;
      overnight fasting were analysed for glucose, lipid profile, ESR, hsCRP, proinflammatory&#xD;
      cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6) and interleukin-17&#xD;
      (IL-17). The primary outcome measures included improvement in ACR20. Secondary endpoints&#xD;
      included reduction in PASI score, DAS28-CRP response and physician and patient global&#xD;
      assessment (PGA). Safety and tolerability were also assessed. Data was collected at baseline&#xD;
      and every 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is evidence that obesity is associated with PsA. Obesity leads to increased&#xD;
      proinflammatory cytokines which may contribute to the development of multiple disturbances in&#xD;
      PsA patients.&#xD;
&#xD;
      A 12 month, randomized single blind clinical trial was conducted to determine whether&#xD;
      long-term exercise and dietary weight loss are more efficacious, either separately or in&#xD;
      combination, than standard care alone in improving physical function, pain, fatigue,&#xD;
      depression and systemic inflammation in obese adults with PsA.&#xD;
&#xD;
      Fifty-five obese ethnically homogenous adult PsA patients with a body mass index (BMI) ≥30,&#xD;
      who satisfied the classification of psoriatic arthritis criteria were recruited. Patients&#xD;
      were randomized into usual lifestyle (controls), diet only, exercise only, and diet plus&#xD;
      exercise groups together with the continued use of standard treatment.&#xD;
&#xD;
      Exclusion criteria included other inflammatory conditions. Detailed skin and rheumatological&#xD;
      assessment was conducted. Disease activity was assessed by psoriasis area and severity index&#xD;
      (PASI), disease activity score (DAS28CRP), Health Assessment Questionnaire- Disability Index&#xD;
      (HAQ-DI), Beck's Depression Inventory (BDI) and fatigue numeric rating scale. Blood samples&#xD;
      collected after 12 hours overnight fasting were analysed for glucose, lipid profile, ESR,&#xD;
      hsCRP, proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6&#xD;
      (IL-6) and interleukin-17 (IL-17). The primary outcome measures included improvement in&#xD;
      ACR20, systemic inflammation markers, BMI, physical function, pain, fatigue, depression and&#xD;
      HAQ-DI. Secondary endpoints included reduction in PASI score, DAS28-CRP response and&#xD;
      physician and patient global assessment (PGA). Safety and tolerability were also assessed.&#xD;
      Data was collected at baseline and every 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ACR20 response</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PASI score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DAS28-CRP response</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physician global assessment (PGA)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient global assessment (PGA)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Psoriatic Arthritis</condition>
  <arm_group>
    <arm_group_label>Diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Low-fat diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>3-day/week exercise programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet and exercise</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>healthy low fat diet and 3day/week exercise programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy lifestyle (Control) group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control group was provided with health education using videotaped presentation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet</intervention_name>
    <arm_group_label>Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet and Exercise</intervention_name>
    <arm_group_label>Diet and exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy Lifestyle (Control) Group</intervention_name>
    <arm_group_label>Healthy lifestyle (Control) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PsA patients with a body mass index (BMI) ≥30&#xD;
&#xD;
          -  Must satisfy the classification of psoriatic arthritis criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other inflammatory conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Abou-Raya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alexandria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alexandria</name>
      <address>
        <city>Alexandria</city>
        <zip>00203</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Anna Abou-Raya</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Psoriatic arthritis</keyword>
  <keyword>inflammation</keyword>
  <keyword>obesity</keyword>
  <keyword>diet</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
  </condition_browse>
  <!-- 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/NCT02188641
org study id: alexmed12671300
nct id: NCT02188641
lead sponsor: 
has dmc: Yes
Psoriatic arthritis (PsA) is a particular pattern of inflammatory arthritis often seen in
      association with psoriasis. PsA patients have a higher prevalence of comorbidities including
      obesity, metabolic syndrome, depression and premature cardiovascular disease. There is
      evidence that obesity is associated with PsA. A 12 month study was conducted to determine
      whether exercise and dietary weight loss are more efficacious, either separately or in
      combination, than standard care alone in improving symptoms and signs in obese adults with
      PsA.

      Fifty-five obese PsA patients with a body mass index (BMI) ≥30, were recruited. Patients were
      randomized into usual lifestyle (controls), diet only, exercise only, and diet plus exercise
      groups for 12 months. Disease activity was assessed. Blood samples collected after 12 hours
      overnight fasting were analysed for glucose, lipid profile, ESR, hsCRP, proinflammatory
      cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6) and interleukin-17
      (IL-17). The primary outcome measures included improvement in ACR20. Secondary endpoints
      included reduction in PASI score, DAS28-CRP response and physician and patient global
      assessment (PGA). Safety and tolerability were also assessed. Data was collected at baseline
      and every 6 months.
There is evidence that obesity is associated with PsA. Obesity leads to increased
      proinflammatory cytokines which may contribute to the development of multiple disturbances in
      PsA patients.

      A 12 month, randomized single blind clinical trial was conducted to determine whether
      long-term exercise and dietary weight loss are more efficacious, either separately or in
      combination, than standard care alone in improving physical function, pain, fatigue,
      depression and systemic inflammation in obese adults with PsA.

      Fifty-five obese ethnically homogenous adult PsA patients with a body mass index (BMI) ≥30,
      who satisfied the classification of psoriatic arthritis criteria were recruited. Patients
      were randomized into usual lifestyle (controls), diet only, exercise only, and diet plus
      exercise groups together with the continued use of standard treatment.

      Exclusion criteria included other inflammatory conditions. Detailed skin and rheumatological
      assessment was conducted. Disease activity was assessed by psoriasis area and severity index
      (PASI), disease activity score (DAS28CRP), Health Assessment Questionnaire- Disability Index
      (HAQ-DI), Beck's Depression Inventory (BDI) and fatigue numeric rating scale. Blood samples
      collected after 12 hours overnight fasting were analysed for glucose, lipid profile, ESR,
      hsCRP, proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6
      (IL-6) and interleukin-17 (IL-17). The primary outcome measures included improvement in
      ACR20, systemic inflammation markers, BMI, physical function, pain, fatigue, depression and
      HAQ-DI. Secondary endpoints included reduction in PASI score, DAS28-CRP response and
      physician and patient global assessment (PGA). Safety and tolerability were also assessed.
      Data was collected at baseline and every 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: ACR20 response
time frame: 12 months
measure: PASI score
time frame: 12 months
measure: DAS28-CRP response
time frame: 12 months
measure: physician global assessment (PGA)
time frame: 12 months
measure: patient global assessment (PGA)
time frame: 12 months
arm group label: Diet
arm group type: Other
description: Low-fat diet
arm group label: Exercise
arm group type: Other
description: 3-day/week exercise programme
arm group label: Diet and exercise
arm group type: Other
description: healthy low fat diet and 3day/week exercise programme
arm group label: Healthy lifestyle (Control) group
arm group type: Other
description: Control group was provided with health education using videotaped presentation
intervention type: Other
intervention name: Diet
arm group label: Diet
intervention type: Other
intervention name: Exercise
arm group label: Exercise
intervention type: Other
intervention name: Diet and Exercise
arm group label: Diet and exercise
intervention type: Other
intervention name: Healthy Lifestyle (Control) Group
arm group label: Healthy lifestyle (Control) group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna Abou-Raya, MD
role: Principal Investigator
affiliation: University of Alexandria
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: University of Alexandria
investigator full name: Anna Abou-Raya
investigator title: MD
mesh term: Arthritis
mesh term: Arthritis, Psoriatic