<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/NCT04437134</url>
  </required_header>
  <id_info>
    <org_study_id>SlagelseH</org_study_id>
    <secondary_id>J.nr. 20-000013</secondary_id>
    <nct_id>NCT04437134</nct_id>
  </id_info>
  <brief_title>On-line Neuromuscular Exercise and Education for Knee Osteoarthritis</brief_title>
  <official_title>On-line Neuromuscular Exercise and Education for Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Slagelse Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Zealand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Slagelse Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Due to enforced social distancing as a direct consequence of the COVID-19 pandemic, many&#xD;
      on-site health care services are unavailable. This study seeks to investigate the relative&#xD;
      effectiveness of an alternative on-line delivery model of exercise and education compared to&#xD;
      on-site delivery in patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Due to the extraordinary events of the 2020 COVID-19 pandemic, finding alternative&#xD;
      delivery-models of treatment has come to the forefront of public health services worldwide.&#xD;
      Consequently, on-line treatment is rapidly becoming an integral part of public health&#xD;
      service. For patients with knee osteoarthritis (OA), where non-pharmacological and&#xD;
      non-surgical treatment is considered first-line treatment, on-line delivered exercise has&#xD;
      already shown promise and may be a viable treatment option, especially when traditional&#xD;
      on-site exercise delivery models are unavailable. However, further studies are needed to&#xD;
      clarify the relative effectiveness of on-line exercise and education when compared to on-site&#xD;
      exercise and education programs.&#xD;
&#xD;
      This study aims to evaluate the effects of on-line exercise and education in knee OA compared&#xD;
      to a cohort of similar knee OA patients completing the same exercise and education program&#xD;
      through on-site delivery.&#xD;
&#xD;
      This study includes two cohorts of knee OA patients receiving the same exercise and education&#xD;
      program through different delivery models (on-line vs. on-site). The on-line cohort is a new&#xD;
      treatment delivery initiative, born out of the COVID-19 enforced shutdown of all non-critical&#xD;
      on-site health care. The on-site cohort is comprised of knee OA patients from a patient&#xD;
      registry, collecting outcome data as part of the exercise and education program.&#xD;
&#xD;
      The exercise and education program is called Good Life with osteoArthritis in Denmark&#xD;
      (GLA:D), and consists of two to three disease-specific educational sessions and 12&#xD;
      neuromuscular exercise sessions (NEMEX-TJR). GLA:D originates from Denmark and has currently&#xD;
      been implemented in Australia, Canada, China, Switzerland and New Zealand.&#xD;
&#xD;
      This study will primarily compare outcomes of pain, function and quality of life between the&#xD;
      two different treatment delivery models and will provide important insights in effectiveness&#xD;
      of alternative delivery models of recommended first-line care for patients with knee OA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">June 14, 2022</completion_date>
  <primary_completion_date type="Actual">July 10, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Knee impact summary</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Summary score from the Knee injury and Osteoarthritis Outcome Score, short version (KOOS 12). The summary score is calculated as the average score from the KOOS 12 subscales pain, function and quality of life (QOL), ranging from 0 (worst) to 100 (best).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fast-paced walking ability</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)</time_frame>
    <description>Fast-paced walking ability is recorded by the physiotherapists and evaluated using the 40-m fast-paced walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chair-stand ability</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)</time_frame>
    <description>Chair-stand ability is recorded by the physiotherapists and evaluated using the 30-s chair-stand test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported function</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of function during daily life using the subscale function from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported pain</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of pain using the subscale pain from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported quality of life</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of quality of life using the subscale quality of life from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Mean pain intensity during the last week in the most affected knee is evaluated on a 100 mm visual analogue scale (VAS) with terminal descriptors of 'no pain' (0 mm) and 'maximum pain' (100 mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity and exercise</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of time spent (frequency and duration) on structured physical activity and exercise.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of satisfaction with the GLA:D program.</description>
  </other_outcome>
  <other_outcome>
    <measure>Continuation of exercise</measure>
    <time_frame>Follow-up point: 12 months</time_frame>
    <description>Patients self-reporting if, how and where they have continued exercising.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported activity levels</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report their current activity levels using the University of California, Los Angeles (UCLA) activity scale, ranging from 1 (inactive, dependent on others) to 10 (regular participation in high-impact sports).</description>
  </other_outcome>
  <other_outcome>
    <measure>Usage of what was learned during GLA:D</measure>
    <time_frame>Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of use of acquired skills and knowledge from the GLA:D program.</description>
  </other_outcome>
  <other_outcome>
    <measure>Symptom management</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of how they handle flare-ups in their knee OA symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intake of pain killers</measure>
    <time_frame>Primary follow-up: Change from baseline to completion of GLA:D program (an average of three months).</time_frame>
    <description>Intake of painkillers is evaluated by the physiotherapist asking the patients about intake of any joint related medication. If taking painkillers, the patients are asked which type and whether or not they were taken because of their knee pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sick leave</measure>
    <time_frame>Follow-up points: Baseline and 12 months</time_frame>
    <description>Patients self-report of sick leave due to knee symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health-related quality of life, index score</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of their health situation using EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) score (-0.624 to 1; worst to best).</description>
  </other_outcome>
  <other_outcome>
    <measure>Health-related quality of life, visual analogue scale</measure>
    <time_frame>Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of their health situation using the EuroQol visual analogue scale (EQ VAS), ranging from 0-100 (worst to best).</description>
  </other_outcome>
  <other_outcome>
    <measure>Global perceived effect</measure>
    <time_frame>Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months</time_frame>
    <description>Patients self-report of current knee condition compared to before participation in GLA:D, scored on a 7-point likert scale (much worse to much better).</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain during exercise (only for on-line group)</measure>
    <time_frame>Immediately prior to, and immediately after each exercise session</time_frame>
    <description>Patients self-report of pain during each exercise session, rated using a numeric pain rating scale (NPRS) 0-10, with zero representing no pain and 10 representing extreme pain.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3789</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>On-line exercise and education</arm_group_label>
    <description>Exercise (12 sessions) and education (2-3 sessions) delivered on-line. Patients attend both the exercise and educational sessions by logging on to virtual rooms using links sent out by e-mail. The sessions are led and supervised by GLA:D certified physiotherapists.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>On-site exercise and education</arm_group_label>
    <description>Exercise (12 sessions) and education (2-3 sessions) delivered on-site. Patients attend both the exercise and educational sessions at physiotherapy clinics in Denmark. The sessions are led and supervised by GLA:D certified physiotherapists.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>On-line exercise and education</intervention_name>
    <description>Exercise:&#xD;
Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. Patients are instructed in how to use alternative equipment at home for each exercise if necessary prior to the first on-line exercise session.&#xD;
Education:&#xD;
Patients attend two to three on-line educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.</description>
    <arm_group_label>On-line exercise and education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>On-site exercise and education</intervention_name>
    <description>Exercise:&#xD;
Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. The exercise sessions are delivered at physiotherapy clinics in Denmark.&#xD;
Education:&#xD;
Patients attend two to three on-site educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.</description>
    <arm_group_label>On-site exercise and education</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients included into this study are adults, reporting knee OA symptoms as their main&#xD;
        source of pain.&#xD;
&#xD;
        Both study groups (on-line and on-site exercise and education) are comprised of patients&#xD;
        with symptomatically verified (all) and radiographically verified (most) knee OA.&#xD;
&#xD;
        On-line exercise and education:&#xD;
&#xD;
        Patients referred for assessment in secondary care due to knee OA symptoms.&#xD;
&#xD;
        On-site exercise and education:&#xD;
&#xD;
        Patients with knee OA symptoms referred to a physiotherapist either by their general&#xD;
        practitioner, by an orthopedic surgeon, or by self-referral.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Knee OA symptoms resulting in contact with the health care system&#xD;
&#xD;
        Exclusion criteria (both study groups):&#xD;
&#xD;
          -  Another reason than OA for the problems; includes tumour or inflammatory joint disease&#xD;
&#xD;
          -  Other symptoms that are more pronounced than the OA symptoms; i.e. chronic,&#xD;
             generalised pain or fibromyalgia.&#xD;
&#xD;
        In addition, for the on-line study group:&#xD;
&#xD;
          -  Previous participation in similar exercise and education programs (i.e. the on-site&#xD;
             version)&#xD;
&#xD;
          -  Lack of necessary equipment or skills to administer on-line participation&#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>Pætur M Holm, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physiotherapy and Occupational Therapy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Søren T Skou, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Physiotherapy and occupational Therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern Denmark</name>
      <address>
        <city>Odense</city>
        <state>Region Southern Denmark</state>
        <zip>5230</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals</name>
      <address>
        <city>Næstved</city>
        <state>Region Zealand</state>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals</name>
      <address>
        <city>Næstved</city>
        <state>Region Zealand</state>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals</name>
      <address>
        <city>Slagelse</city>
        <state>Region Zealand</state>
        <zip>4200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Slagelse Hospital</investigator_affiliation>
    <investigator_full_name>Pætur Mikal Holm</investigator_full_name>
    <investigator_title>Physiotherapist, PhD, Postdoc.</investigator_title>
  </responsible_party>
  <keyword>Knee</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Exercise</keyword>
  <keyword>Education</keyword>
  <keyword>On-line</keyword>
  <keyword>Pain</keyword>
  <keyword>Function</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04437134
org study id: SlagelseH
secondary id: J.nr. 20-000013
nct id: NCT04437134
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Due to enforced social distancing as a direct consequence of the COVID-19 pandemic, many
      on-site health care services are unavailable. This study seeks to investigate the relative
      effectiveness of an alternative on-line delivery model of exercise and education compared to
      on-site delivery in patients with knee osteoarthritis.
Due to the extraordinary events of the 2020 COVID-19 pandemic, finding alternative
      delivery-models of treatment has come to the forefront of public health services worldwide.
      Consequently, on-line treatment is rapidly becoming an integral part of public health
      service. For patients with knee osteoarthritis (OA), where non-pharmacological and
      non-surgical treatment is considered first-line treatment, on-line delivered exercise has
      already shown promise and may be a viable treatment option, especially when traditional
      on-site exercise delivery models are unavailable. However, further studies are needed to
      clarify the relative effectiveness of on-line exercise and education when compared to on-site
      exercise and education programs.

      This study aims to evaluate the effects of on-line exercise and education in knee OA compared
      to a cohort of similar knee OA patients completing the same exercise and education program
      through on-site delivery.

      This study includes two cohorts of knee OA patients receiving the same exercise and education
      program through different delivery models (on-line vs. on-site). The on-line cohort is a new
      treatment delivery initiative, born out of the COVID-19 enforced shutdown of all non-critical
      on-site health care. The on-site cohort is comprised of knee OA patients from a patient
      registry, collecting outcome data as part of the exercise and education program.

      The exercise and education program is called Good Life with osteoArthritis in Denmark
      (GLA:D), and consists of two to three disease-specific educational sessions and 12
      neuromuscular exercise sessions (NEMEX-TJR). GLA:D originates from Denmark and has currently
      been implemented in Australia, Canada, China, Switzerland and New Zealand.

      This study will primarily compare outcomes of pain, function and quality of life between the
      two different treatment delivery models and will provide important insights in effectiveness
      of alternative delivery models of recommended first-line care for patients with knee OA.
observational model: Other
time perspective: Other
measure: Knee impact summary
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Summary score from the Knee injury and Osteoarthritis Outcome Score, short version (KOOS 12). The summary score is calculated as the average score from the KOOS 12 subscales pain, function and quality of life (QOL), ranging from 0 (worst) to 100 (best).
measure: Fast-paced walking ability
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
description: Fast-paced walking ability is recorded by the physiotherapists and evaluated using the 40-m fast-paced walk test.
measure: Chair-stand ability
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
description: Chair-stand ability is recorded by the physiotherapists and evaluated using the 30-s chair-stand test.
measure: Self-reported function
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of function during daily life using the subscale function from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).
measure: Self-reported pain
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of pain using the subscale pain from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).
measure: Self-reported quality of life
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of quality of life using the subscale quality of life from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).
measure: Pain intensity
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Mean pain intensity during the last week in the most affected knee is evaluated on a 100 mm visual analogue scale (VAS) with terminal descriptors of 'no pain' (0 mm) and 'maximum pain' (100 mm).
measure: Physical activity and exercise
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of time spent (frequency and duration) on structured physical activity and exercise.
measure: Patient satisfaction
time frame: Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of satisfaction with the GLA:D program.
measure: Continuation of exercise
time frame: Follow-up point: 12 months
description: Patients self-reporting if, how and where they have continued exercising.
measure: Self-reported activity levels
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report their current activity levels using the University of California, Los Angeles (UCLA) activity scale, ranging from 1 (inactive, dependent on others) to 10 (regular participation in high-impact sports).
measure: Usage of what was learned during GLA:D
time frame: Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of use of acquired skills and knowledge from the GLA:D program.
measure: Symptom management
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of how they handle flare-ups in their knee OA symptoms.
measure: Intake of pain killers
time frame: Primary follow-up: Change from baseline to completion of GLA:D program (an average of three months).
description: Intake of painkillers is evaluated by the physiotherapist asking the patients about intake of any joint related medication. If taking painkillers, the patients are asked which type and whether or not they were taken because of their knee pain.
measure: Sick leave
time frame: Follow-up points: Baseline and 12 months
description: Patients self-report of sick leave due to knee symptoms.
measure: Health-related quality of life, index score
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of their health situation using EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) score (-0.624 to 1; worst to best).
measure: Health-related quality of life, visual analogue scale
time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of their health situation using the EuroQol visual analogue scale (EQ VAS), ranging from 0-100 (worst to best).
measure: Global perceived effect
time frame: Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
description: Patients self-report of current knee condition compared to before participation in GLA:D, scored on a 7-point likert scale (much worse to much better).
measure: Pain during exercise (only for on-line group)
time frame: Immediately prior to, and immediately after each exercise session
description: Patients self-report of pain during each exercise session, rated using a numeric pain rating scale (NPRS) 0-10, with zero representing no pain and 10 representing extreme pain.
arm group label: On-line exercise and education
description: Exercise (12 sessions) and education (2-3 sessions) delivered on-line. Patients attend both the exercise and educational sessions by logging on to virtual rooms using links sent out by e-mail. The sessions are led and supervised by GLA:D certified physiotherapists.
arm group label: On-site exercise and education
description: Exercise (12 sessions) and education (2-3 sessions) delivered on-site. Patients attend both the exercise and educational sessions at physiotherapy clinics in Denmark. The sessions are led and supervised by GLA:D certified physiotherapists.
intervention type: Other
intervention name: On-line exercise and education
description: Exercise:
Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. Patients are instructed in how to use alternative equipment at home for each exercise if necessary prior to the first on-line exercise session.
Education:
Patients attend two to three on-line educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.
arm group label: On-line exercise and education
intervention type: Other
intervention name: On-site exercise and education
description: Exercise:
Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. The exercise sessions are delivered at physiotherapy clinics in Denmark.
Education:
Patients attend two to three on-site educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.
arm group label: On-site exercise and education
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pætur M Holm, PhD
role: Principal Investigator
affiliation: Department of Physiotherapy and Occupational Therapy
last name: Søren T Skou, Professor
role: Study Chair
affiliation: Department of Physiotherapy and occupational Therapy
facility: 
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Slagelse Hospital
investigator full name: Pætur Mikal Holm
investigator title: Physiotherapist, PhD, Postdoc.
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Undecided