<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/NCT03288688</url>
  </required_header>
  <id_info>
    <org_study_id>Orch musicians</org_study_id>
    <nct_id>NCT03288688</nct_id>
  </id_info>
  <brief_title>Effect of an Exercise Program Designed for Orchestral Musicians</brief_title>
  <official_title>Effect of an Exercise Program Designed for Professional Orchestral Musicians on Performance-related Musculoskeletal Problems - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</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>
      This study is a randomized clinical trial evaluating the effect of an exercise program&#xD;
      designed specifically for orchestral musicians on performance-related musculoskeletal&#xD;
      problems (PRMPs). Professional and conservatory-level orchestral musicians will be recruited.&#xD;
      Half of the subjects will participate in an 11-week home exercise program and attend three&#xD;
      group exercise sessions and an educational presentation on injury prevention, while the other&#xD;
      half of the subjects will receive no intervention, and continue their usual activities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Actual">November 17, 2017</completion_date>
  <primary_completion_date type="Actual">November 17, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM)</measure>
    <time_frame>Baseline-11 weeks</time_frame>
    <description>A biopsychosocial self-report questionnaire used to obtain demographic and occupational information and to document the intensity and impact of performance-related musculoskeletal pain/problems</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Nordic Musculoskeletal Questionnaire (NMQ)</measure>
    <time_frame>Baseline-11 weeks</time_frame>
    <description>Self-report questionnaire on pain/symptom prevalence in the different regions of the body</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change</measure>
    <time_frame>11 weeks</time_frame>
    <description>Questionnaire designed to quantify participants' perceived improvement or deterioration over the course of the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Musculoskeletal Disorder</condition>
  <arm_group>
    <arm_group_label>Exercise program and education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An exercise program in the form of home exercise videos will be given to the participants in this group. They will be asked to perform a minimum of two 35-minute exercise sessions per week, over a period of 11 weeks. They will also be required to attend three group exercise sessions, to confirm correct execution of the exercises. A short educational presentation on injury prevention will be offered at the beginning of the study, followed by three informative e-mails over the course of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will be asked to continue their usual activities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise program and education</intervention_name>
    <description>The exercise program comprises warm-ups, exercises and cool-downs and aims to improve recruitment, strength and endurance of postural muscle groups that are key to the work of a musician. Basic activation exercises progress to dynamic and resisted exercises as well as functional musical movements. There is a series of six exercises of increasing difficulty for each of the following bodily regions: hips, back, neck, shoulders and abdominals.&#xD;
Topics to be discussed in the educational presentation and e-mails include healthy practice habits, activity dosage, the importance of physical activity, how the body adapts to workload and physical stressors, and instructions pertaining to the exercise program.</description>
    <arm_group_label>Exercise program and education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  professional or freelance orchestral musician, or tertiary-level full-time music&#xD;
             student majoring in an orchestral instrument&#xD;
&#xD;
          -  able to commit to performing exercises 2 times per week over an 11-week period&#xD;
&#xD;
          -  medical condition permitting participation in an exercise program (ie. no serious&#xD;
             heart or lung condition that may be exacerbated by physical exertion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of musculoskeletal injuries definitively non-related to musical practice or&#xD;
             performance&#xD;
&#xD;
          -  fewer than 15 hours per week playing their instrument&#xD;
&#xD;
          -  corticosteroid infiltration in the 6 weeks preceding recruitment&#xD;
&#xD;
          -  prescribed anti-inflammatory drugs or neurontin in the 3 weeks preceding recruitment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CIRRIS</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1M 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>June 8, 2018</last_update_submitted>
  <last_update_submitted_qc>June 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Jean-Sébastien Roy</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</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/NCT03288688
org study id: Orch musicians
nct id: NCT03288688
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized clinical trial evaluating the effect of an exercise program
      designed specifically for orchestral musicians on performance-related musculoskeletal
      problems (PRMPs). Professional and conservatory-level orchestral musicians will be recruited.
      Half of the subjects will participate in an 11-week home exercise program and attend three
      group exercise sessions and an educational presentation on injury prevention, while the other
      half of the subjects will receive no intervention, and continue their usual activities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM)
time frame: Baseline-11 weeks
description: A biopsychosocial self-report questionnaire used to obtain demographic and occupational information and to document the intensity and impact of performance-related musculoskeletal pain/problems
measure: The Nordic Musculoskeletal Questionnaire (NMQ)
time frame: Baseline-11 weeks
description: Self-report questionnaire on pain/symptom prevalence in the different regions of the body
measure: Global Rating of Change
time frame: 11 weeks
description: Questionnaire designed to quantify participants' perceived improvement or deterioration over the course of the study
arm group label: Exercise program and education
arm group type: Experimental
description: An exercise program in the form of home exercise videos will be given to the participants in this group. They will be asked to perform a minimum of two 35-minute exercise sessions per week, over a period of 11 weeks. They will also be required to attend three group exercise sessions, to confirm correct execution of the exercises. A short educational presentation on injury prevention will be offered at the beginning of the study, followed by three informative e-mails over the course of the study.
arm group label: No intervention
arm group type: No Intervention
description: Participants in this group will be asked to continue their usual activities.
intervention type: Other
intervention name: Exercise program and education
description: The exercise program comprises warm-ups, exercises and cool-downs and aims to improve recruitment, strength and endurance of postural muscle groups that are key to the work of a musician. Basic activation exercises progress to dynamic and resisted exercises as well as functional musical movements. There is a series of six exercises of increasing difficulty for each of the following bodily regions: hips, back, neck, shoulders and abdominals.
Topics to be discussed in the educational presentation and e-mails include healthy practice habits, activity dosage, the importance of physical activity, how the body adapts to workload and physical stressors, and instructions pertaining to the exercise program.
arm group label: Exercise program and education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Jean-Sébastien Roy
investigator title: PhD
mesh term: Musculoskeletal Diseases