<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/NCT01697241</url>
  </required_header>
  <id_info>
    <org_study_id>S-20120109</org_study_id>
    <nct_id>NCT01697241</nct_id>
  </id_info>
  <brief_title>Effect of Exercise as Non-surgical Treatments on Time to Total Hip Replacement Surgery</brief_title>
  <acronym>HipSPORT</acronym>
  <official_title>The Effect of Education and Supervised Exercise vs. Education Alone on Time to Total Hip Replacement in Patients With Hip Osteoarthritis Considered Eligible for Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute for Clinical Research, Denmark</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vejle Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Danish Rheumatism Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis&#xD;
      postpone time to hip replacement surgery following participation in a patient education and&#xD;
      supervised exercise program when compared to patients receiving patient education alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hip replacements are performed at an increasing rate, also in younger and less disabled&#xD;
      patients. Recent studies indicate non-surgical interventions being effective in reducing pain&#xD;
      and disability also at later stages of disease when hip replacement is considered. Possible,&#xD;
      non-surgical treatments can be used to postpone hip replacement. The effect of education and&#xD;
      supervised exercise on time to hip replacement is largely unknown&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2013</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative Survival analysis (Kaplan-Maier survival curve)</measure>
    <time_frame>one year</time_frame>
    <description>Cumulative Survival analysis as time in days without surgery since inclusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)</measure>
    <time_frame>Baseline, 3 and 12 months</time_frame>
    <description>HOOS is patient-reported outcome measure with 5 subscales for pain, other symptoms, function in daily living, function in sport and recreation and hip related Quality of Life. A 5-point Likert-scale is used and converted into a 100-point scale with zero indicating the worst possible health (http://www.koos.nu).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>University of California Los Angeles activity score (UCLA)</measure>
    <time_frame>Baseline, 3 and 12 months</time_frame>
    <description>Physical activity levels in populations. UCLA is a 10-point likert scale recommended and used extensively in similar populations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global perceived effect (GPE) score</measure>
    <time_frame>3 and 12 months</time_frame>
    <description>Patients will be asked to rate possible change in their pain, symptoms, ADL, sports and recreation, quality of life, level of physical activity since the initial administration (baseline) on a 7-point Likert-scale.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-reported exercise pain (VAS-scale)</measure>
    <time_frame>3 months</time_frame>
    <description>Pain intensity using the VAS-scale. Participants will be followed for the duration of the exercise intervention (3 months) and be asked to rate pain intensity before and after each exercise session (total 24 sessions)</description>
  </other_outcome>
  <other_outcome>
    <measure>Exercise adherence</measure>
    <time_frame>3 months</time_frame>
    <description>'The extent to which a person's behavior corresponds with agreed recommendations from a health care provider' using no. of weeks, and no. of completed sessions</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost-effectiveness analysis</measure>
    <time_frame>12 months</time_frame>
    <description>Cost-effectiveness analysis will be estimated as the ratio between cost of the intervention and the effect it produces. The total cost will be estimated from register-based costing of primary care, secondary care and patient's out-of-pocket costs (transportation expenses and time spent on transportation and receiving health care). Patient-reported values are weighted using Danish tariffs</description>
  </other_outcome>
  <other_outcome>
    <measure>General health status EuroQol (EQ-5D-5L)</measure>
    <time_frame>Baseline, 3 and 12 months</time_frame>
    <description>The EQ-5D is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression (http://www.euroqol.org)</description>
  </other_outcome>
  <other_outcome>
    <measure>Mechanical Muscle Function</measure>
    <time_frame>Baseline, 3 and 12 months</time_frame>
    <description>Isometric muscle strength (iMVC) will be collected for knee extensors, hip extensors, -flexors and hip abductors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical performance battery</measure>
    <time_frame>Baseline, 3 and 12 months</time_frame>
    <description>Physical performance-based measures will include; 30 s chair stand (number completed), 20 meter fast-paced walk (time in (s)), 30 s single-leg knee bending (number completed), and timed up and go (time in sec.)</description>
  </other_outcome>
  <other_outcome>
    <measure>Poor compliance</measure>
    <time_frame>3 months</time_frame>
    <description>Reasons for poor compliance will be recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>Joint specific adverse events</measure>
    <time_frame>3 months</time_frame>
    <description>Joint specific adverse events will be determined as: 1) not attending a training session and/or ceasing training because of increased pain/problems in the index joint related to the training; and 2) self-reported exercise pain &gt; 5 on the VAS-scale after training. The reasons for not attending a session due to pain/problems related to training or to other reasons will be recorded.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Supervised exercise and patient education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The entire duration of the intervention is 12 weeks, and consists of 24 sessions each lasting 60-70 minutes. Patients will receive two types of exercises, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX) in groups with progression guided by the patient's neuromuscular function (12 sessions). The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load (12 sessions).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Education</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supervised exercise</intervention_name>
    <description>Patients in the exercise groups will receive two types of exercise, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX-TJR) in groups with progression guided by the patient's neuromuscular function. The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load. Each of the two types of exercise will be offered weekly during the 12 week intervention period in sessions lasting 60-70 minutes. Thus, the entire exercise intervention consists of 24 sessions</description>
    <arm_group_label>Supervised exercise and patient education</arm_group_label>
    <other_name>NEMEX-TJR and RT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient education</intervention_name>
    <description>The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration</description>
    <arm_group_label>Patient Education</arm_group_label>
    <arm_group_label>Supervised exercise and patient education</arm_group_label>
    <other_name>BOA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 years and older&#xD;
&#xD;
          -  Indication for total hip arthroplasty&#xD;
&#xD;
          -  Residency within local municipal or willing to commute&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammatory joint disease&#xD;
&#xD;
          -  Earlier ipsilateral proximal femur fracture&#xD;
&#xD;
          -  Hip pain &lt; 3 months&#xD;
&#xD;
          -  Neuropathy or neuromuscular disease&#xD;
&#xD;
          -  Malignant disease&#xD;
&#xD;
          -  Diseases where a moderate level of physical exercise is contraindicated&#xD;
&#xD;
          -  Unable to speak or read Danish&#xD;
&#xD;
          -  Unable to participate for other reasons&#xD;
&#xD;
          -  Refuse to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carsten Jensen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. Institute of Clinical Research, University of Southern Denmark, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark</name>
      <address>
        <city>Odense</city>
        <zip>5200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>May 4, 2018</last_update_submitted>
  <last_update_submitted_qc>May 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Carsten Jensen</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Exercise Therapy</keyword>
  <keyword>Education</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Hip</keyword>
  <keyword>Hip replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT01697241
org study id: S-20120109
nct id: NCT01697241
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis
      postpone time to hip replacement surgery following participation in a patient education and
      supervised exercise program when compared to patients receiving patient education alone.
Hip replacements are performed at an increasing rate, also in younger and less disabled
      patients. Recent studies indicate non-surgical interventions being effective in reducing pain
      and disability also at later stages of disease when hip replacement is considered. Possible,
      non-surgical treatments can be used to postpone hip replacement. The effect of education and
      supervised exercise on time to hip replacement is largely unknown
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Cumulative Survival analysis (Kaplan-Maier survival curve)
time frame: one year
description: Cumulative Survival analysis as time in days without surgery since inclusion
measure: The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)
time frame: Baseline, 3 and 12 months
description: HOOS is patient-reported outcome measure with 5 subscales for pain, other symptoms, function in daily living, function in sport and recreation and hip related Quality of Life. A 5-point Likert-scale is used and converted into a 100-point scale with zero indicating the worst possible health (http://www.koos.nu).
measure: University of California Los Angeles activity score (UCLA)
time frame: Baseline, 3 and 12 months
description: Physical activity levels in populations. UCLA is a 10-point likert scale recommended and used extensively in similar populations
measure: Global perceived effect (GPE) score
time frame: 3 and 12 months
description: Patients will be asked to rate possible change in their pain, symptoms, ADL, sports and recreation, quality of life, level of physical activity since the initial administration (baseline) on a 7-point Likert-scale.
measure: Self-reported exercise pain (VAS-scale)
time frame: 3 months
description: Pain intensity using the VAS-scale. Participants will be followed for the duration of the exercise intervention (3 months) and be asked to rate pain intensity before and after each exercise session (total 24 sessions)
measure: Exercise adherence
time frame: 3 months
description: 'The extent to which a person's behavior corresponds with agreed recommendations from a health care provider' using no. of weeks, and no. of completed sessions
measure: Cost-effectiveness analysis
time frame: 12 months
description: Cost-effectiveness analysis will be estimated as the ratio between cost of the intervention and the effect it produces. The total cost will be estimated from register-based costing of primary care, secondary care and patient's out-of-pocket costs (transportation expenses and time spent on transportation and receiving health care). Patient-reported values are weighted using Danish tariffs
measure: General health status EuroQol (EQ-5D-5L)
time frame: Baseline, 3 and 12 months
description: The EQ-5D is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression (http://www.euroqol.org)
measure: Mechanical Muscle Function
time frame: Baseline, 3 and 12 months
description: Isometric muscle strength (iMVC) will be collected for knee extensors, hip extensors, -flexors and hip abductors.
measure: Physical performance battery
time frame: Baseline, 3 and 12 months
description: Physical performance-based measures will include; 30 s chair stand (number completed), 20 meter fast-paced walk (time in (s)), 30 s single-leg knee bending (number completed), and timed up and go (time in sec.)
measure: Poor compliance
time frame: 3 months
description: Reasons for poor compliance will be recorded.
measure: Joint specific adverse events
time frame: 3 months
description: Joint specific adverse events will be determined as: 1) not attending a training session and/or ceasing training because of increased pain/problems in the index joint related to the training; and 2) self-reported exercise pain > 5 on the VAS-scale after training. The reasons for not attending a session due to pain/problems related to training or to other reasons will be recorded.
arm group label: Supervised exercise and patient education
arm group type: Experimental
description: The entire duration of the intervention is 12 weeks, and consists of 24 sessions each lasting 60-70 minutes. Patients will receive two types of exercises, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX) in groups with progression guided by the patient's neuromuscular function (12 sessions). The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load (12 sessions).
arm group label: Patient Education
arm group type: Other
description: The patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration
intervention type: Other
intervention name: Supervised exercise
description: Patients in the exercise groups will receive two types of exercise, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX-TJR) in groups with progression guided by the patient's neuromuscular function. The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load. Each of the two types of exercise will be offered weekly during the 12 week intervention period in sessions lasting 60-70 minutes. Thus, the entire exercise intervention consists of 24 sessions
arm group label: Supervised exercise and patient education
other name: NEMEX-TJR and RT
intervention type: Other
intervention name: Patient education
description: The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration
arm group label: Patient Education
arm group label: Supervised exercise and patient education
other name: BOA
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Carsten Jensen, PhD
role: Principal Investigator
affiliation: Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. Institute of Clinical Research, University of Southern Denmark, Denmark
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Carsten Jensen
investigator title: Assistant Professor
mesh term: Osteoarthritis