<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/NCT01700933</url>
  </required_header>
  <id_info>
    <org_study_id>DROAPS1</org_study_id>
    <nct_id>NCT01700933</nct_id>
  </id_info>
  <brief_title>Dose-response: Exercise Therapy on Hip Osteoarthritis</brief_title>
  <official_title>Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian University of Science and Technology</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>
      Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability.&#xD;
      The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a&#xD;
      well-documented effect on pain and function in patients with osteoarthritis of the hip. It is&#xD;
      sought an optimal dose of exercise, in which this study will help to investigate.&#xD;
&#xD;
      We hypothesize that an exercise program designed to have a high number of repetitions will&#xD;
      benefit the outcome of the training in a more positive way than a low-repetition based&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WOMAC Index of Osteoarthritis (questionnaire)</measure>
    <time_frame>0 weeks, 8 weeks, 6 months postinterventional</time_frame>
    <description>WOMAC Index of Osteoarthritis (questionnaire)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HAD questionnaire</measure>
    <time_frame>0 weeks, 8 weeks, 6 months postinterventional</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa Scale for Kinesiophobia</measure>
    <time_frame>0 weeks, 8 weeks, 6 months postinterventional</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Squats</measure>
    <time_frame>0 weeks, 8 weeks, 6 months postinterventional</time_frame>
    <description>Number of squats completed in 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stairs</measure>
    <time_frame>0 weeks, 8 weeks, 6 months postinterventional</time_frame>
    <description>Time used to walk up and down 12 steps.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>High-dosage-group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-dosage-group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-Dosage Exercise Therapy</intervention_name>
    <description>Structure of the exercise program done three times per week, for eight weeks:&#xD;
5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)</description>
    <arm_group_label>High-dosage-group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-Dosage Exercise Therapy</intervention_name>
    <description>Structure of the exercise program done three times per week, for eight weeks:&#xD;
5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)</description>
    <arm_group_label>Low-dosage-group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least three month since debut of the disease&#xD;
&#xD;
          -  Age above 45 years&#xD;
&#xD;
          -  Ability to complete the intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pain above 4 on VAS during gait&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Autoimmune disease&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Respiratory disease&#xD;
&#xD;
          -  Metabolic disease&#xD;
&#xD;
          -  Neurological signs&#xD;
&#xD;
          -  Planned hip-replacement surgery within the next year&#xD;
&#xD;
          -  Received exercise therapy within the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Håvard Østerås</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fysioterapitjenesten i Ørsta</name>
      <address>
        <city>Ørsta</city>
        <zip>6154</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Osteras H, Paulsberg F, Olsen SE, Osteras B, Torstensen TA. Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study. J Bodyw Mov Ther. 2017 Apr;21(2):284-289. doi: 10.1016/j.jbmt.2016.06.016. Epub 2016 Jul 5.</citation>
    <PMID>28532870</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</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/NCT01700933
org study id: DROAPS1
nct id: NCT01700933
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability.
      The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a
      well-documented effect on pain and function in patients with osteoarthritis of the hip. It is
      sought an optimal dose of exercise, in which this study will help to investigate.

      We hypothesize that an exercise program designed to have a high number of repetitions will
      benefit the outcome of the training in a more positive way than a low-repetition based
      program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: WOMAC Index of Osteoarthritis (questionnaire)
time frame: 0 weeks, 8 weeks, 6 months postinterventional
description: WOMAC Index of Osteoarthritis (questionnaire)
measure: HAD questionnaire
time frame: 0 weeks, 8 weeks, 6 months postinterventional
measure: Tampa Scale for Kinesiophobia
time frame: 0 weeks, 8 weeks, 6 months postinterventional
measure: Squats
time frame: 0 weeks, 8 weeks, 6 months postinterventional
description: Number of squats completed in 30 seconds.
measure: Stairs
time frame: 0 weeks, 8 weeks, 6 months postinterventional
description: Time used to walk up and down 12 steps.
arm group label: High-dosage-group
arm group type: Active Comparator
arm group label: Low-dosage-group
arm group type: Active Comparator
intervention type: Other
intervention name: High-Dosage Exercise Therapy
description: Structure of the exercise program done three times per week, for eight weeks:
5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)
arm group label: High-dosage-group
intervention type: Other
intervention name: Low-Dosage Exercise Therapy
description: Structure of the exercise program done three times per week, for eight weeks:
5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)
arm group label: Low-dosage-group
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Håvard Østerås
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
citation: Osteras H, Paulsberg F, Olsen SE, Osteras B, Torstensen TA. Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study. J Bodyw Mov Ther. 2017 Apr;21(2):284-289. doi: 10.1016/j.jbmt.2016.06.016. Epub 2016 Jul 5.
PMID: 28532870
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip