<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/NCT02995460</url>
  </required_header>
  <id_info>
    <org_study_id>2012/1646</org_study_id>
    <nct_id>NCT02995460</nct_id>
  </id_info>
  <brief_title>Interval Training Study in Psoriatic Arthritis</brief_title>
  <official_title>Interval Training Study in Psoriatic Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helse Midt-Norge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced&#xD;
      physical function. Patients have a higher risk of cardiovascular disease and a higher body&#xD;
      mass index.&#xD;
&#xD;
      A pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation&#xD;
      after 12 weeks of high-intensity interval training.&#xD;
&#xD;
      The primary aim of this study is to determine whether high-intensity interval training&#xD;
      affects the disease activity in psoriatic arthritis. This intervention is believed to result&#xD;
      in benefits in terms of inflammation, body composition and risk factors for cardiovascular&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient global assesment (PGA)</measure>
    <time_frame>Baseline, 3 months (right after intervention), 9 months</time_frame>
    <description>PGA is measured as a change between timepoints. PGA is registered by the patient on a visual analog scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal oxygen uptake (VO2 max)</measure>
    <time_frame>Baseline, 3 months (right after intervention), 9 months</time_frame>
    <description>The VO2 max is measured as a change between timepoints</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total lean mass</measure>
    <time_frame>Baseline, 3 months (right after intervention), 9 months</time_frame>
    <description>Total lean mass is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body fat</measure>
    <time_frame>Baseline, 3 months (right after intervention), 9 months</time_frame>
    <description>Total body fat is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Psoriatic Arthritis</condition>
  <arm_group>
    <arm_group_label>interval training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4x4 high intensity interval training was performed on a stationary bicycle with a supervisor twice a week and by one self-training a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No change in diet and training habits</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>interval training</intervention_name>
    <description>4x4 high intensity interval training</description>
    <arm_group_label>interval training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fulfilling the CASPAR criteria of psoriatic arthritis&#xD;
&#xD;
          -  ability to exercise.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to exercise&#xD;
&#xD;
          -  very high disease Activity&#xD;
&#xD;
          -  unstable ischemic cardiovascular disease&#xD;
&#xD;
          -  severe pulmonary disease&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  breastfeeding&#xD;
&#xD;
          -  drug- and alcohol addictions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Siri Forsmo, md prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <results_reference>
    <citation>Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Impact of High-Intensity Interval Training on Disease Activity and Disease in Patients With Psoriatic Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2019 Apr;71(4):530-537. doi: 10.1002/acr.23614.</citation>
    <PMID>29882634</PMID>
  </results_reference>
  <results_reference>
    <citation>Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Effect of high-intensity interval training on cardiovascular disease risk factors and body composition in psoriatic arthritis: a randomised controlled trial. RMD Open. 2018 Oct 11;4(2):e000729. doi: 10.1136/rmdopen-2018-000729. eCollection 2018.</citation>
    <PMID>30402265</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>November 8, 2018</last_update_submitted>
  <last_update_submitted_qc>November 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise Therapy</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>
  <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/NCT02995460
org study id: 2012/1646
nct id: NCT02995460
lead sponsor: 
collaborator: 
has dmc: No
Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced
      physical function. Patients have a higher risk of cardiovascular disease and a higher body
      mass index.

      A pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation
      after 12 weeks of high-intensity interval training.

      The primary aim of this study is to determine whether high-intensity interval training
      affects the disease activity in psoriatic arthritis. This intervention is believed to result
      in benefits in terms of inflammation, body composition and risk factors for cardiovascular
      disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient global assesment (PGA)
time frame: Baseline, 3 months (right after intervention), 9 months
description: PGA is measured as a change between timepoints. PGA is registered by the patient on a visual analog scale.
measure: Maximal oxygen uptake (VO2 max)
time frame: Baseline, 3 months (right after intervention), 9 months
description: The VO2 max is measured as a change between timepoints
measure: Total lean mass
time frame: Baseline, 3 months (right after intervention), 9 months
description: Total lean mass is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).
measure: Total body fat
time frame: Baseline, 3 months (right after intervention), 9 months
description: Total body fat is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).
arm group label: interval training
arm group type: Experimental
description: 4x4 high intensity interval training was performed on a stationary bicycle with a supervisor twice a week and by one self-training a week.
arm group label: controls
arm group type: No Intervention
description: No change in diet and training habits
intervention type: Behavioral
intervention name: interval training
description: 4x4 high intensity interval training
arm group label: interval training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Siri Forsmo, md prof
role: Study Director
affiliation: Norwegian University of Science and Technology
citation: Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Impact of High-Intensity Interval Training on Disease Activity and Disease in Patients With Psoriatic Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2019 Apr;71(4):530-537. doi: 10.1002/acr.23614.
PMID: 29882634
citation: Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Effect of high-intensity interval training on cardiovascular disease risk factors and body composition in psoriatic arthritis: a randomised controlled trial. RMD Open. 2018 Oct 11;4(2):e000729. doi: 10.1136/rmdopen-2018-000729. eCollection 2018.
PMID: 30402265
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
sharing ipd: No