<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/NCT02258672</url>
  </required_header>
  <id_info>
    <org_study_id>UQTR-CSSSTR 2014</org_study_id>
    <nct_id>NCT02258672</nct_id>
  </id_info>
  <brief_title>Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis</brief_title>
  <official_title>Effects of a Preoperative Rehabilitation Program on the Recovery of Patients Undergoing Surgery for Lumbar Spinal Stenosis: a Feasibility Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université du Québec à Trois-Rivières</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fonds de soutien au démarrage de projets en collaboration (CSSSTR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fonds pour la Recherche Clinique de l'UQTR</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université du Québec à Trois-Rivières</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to evaluate the effectiveness of a prehabilitation&#xD;
      program on the recovery of patients undergoing a minimally invasive surgery for degenerative&#xD;
      lumbar spinal stenosis. To do so, 40 participants will be recruited and randomized into two&#xD;
      groups; intervention or control group. Participants in the intervention group will take part&#xD;
      in a physical training program, three times a week for six weeks before undergoing surgery.&#xD;
      The exercise program will be supervised and will aim at improving core muscles strength and&#xD;
      endurance as well as spine stability. It is hypothesized that the prehabilitation program&#xD;
      will significantly improve disability and pain intensity reported by patients after surgery.&#xD;
      Ultimately, this study aims to improve health care of patients awaiting lumbar surgery but&#xD;
      its results may also impact the management of patients awaiting spine surgery for various&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</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>Change from Baseline in disability</measure>
    <time_frame>baseline, week 6, week 10, week 18, week 30</time_frame>
    <description>Oswestry Disability Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in pain intensity</measure>
    <time_frame>baseline, week 6, week 10, week 18, week 30</time_frame>
    <description>Visual Analog Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Lumbar Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Prehabilitation program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be physically trained before undergoing surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will follow the normal course of care provided by the hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prehabilitation program</intervention_name>
    <description>Progressive and individualized physical training aimed at improving core muscles strength and endurance as well as spinal stability.</description>
    <arm_group_label>Prehabilitation program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be affected by degenerative lumbar spinal stenosis and to be awaiting minimally invasive&#xD;
        surgery for the lumbar spinal stenosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Non-degenerative spinal stenosis, arthritic conditions (except for facet arthrosis),&#xD;
        impaired cognitive function, spinal instability and disagreement from the treating&#xD;
        neurosurgeon for the patient to take part in the preadaptation programme.&#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>Martin Descarreaux, DC, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Université du Québec à Trois-Rivières</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Université du Québec à Trois-Rivières</name>
      <address>
        <city>Trois-Rivières</city>
        <state>Quebec</state>
        <zip>G9A 5H7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université du Québec à Trois-Rivières</investigator_affiliation>
    <investigator_full_name>Martin Descarreaux</investigator_full_name>
    <investigator_title>DC, PhD</investigator_title>
  </responsible_party>
  <keyword>Preoperative rehabilitation</keyword>
  <keyword>Minimally invasive surgery</keyword>
  <keyword>Functional capacity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT02258672
org study id: UQTR-CSSSTR 2014
nct id: NCT02258672
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the present study is to evaluate the effectiveness of a prehabilitation
      program on the recovery of patients undergoing a minimally invasive surgery for degenerative
      lumbar spinal stenosis. To do so, 40 participants will be recruited and randomized into two
      groups; intervention or control group. Participants in the intervention group will take part
      in a physical training program, three times a week for six weeks before undergoing surgery.
      The exercise program will be supervised and will aim at improving core muscles strength and
      endurance as well as spine stability. It is hypothesized that the prehabilitation program
      will significantly improve disability and pain intensity reported by patients after surgery.
      Ultimately, this study aims to improve health care of patients awaiting lumbar surgery but
      its results may also impact the management of patients awaiting spine surgery for various
      conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline in disability
time frame: baseline, week 6, week 10, week 18, week 30
description: Oswestry Disability Index
measure: Change from Baseline in pain intensity
time frame: baseline, week 6, week 10, week 18, week 30
description: Visual Analog Scale
arm group label: Prehabilitation program
arm group type: Experimental
description: Participants will be physically trained before undergoing surgery
arm group label: Control
arm group type: No Intervention
description: Patients will follow the normal course of care provided by the hospital
intervention type: Other
intervention name: Prehabilitation program
description: Progressive and individualized physical training aimed at improving core muscles strength and endurance as well as spinal stability.
arm group label: Prehabilitation program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Descarreaux, DC, PhD
role: Study Director
affiliation: Université du Québec à Trois-Rivières
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université du Québec à Trois-Rivières
investigator full name: Martin Descarreaux
investigator title: DC, PhD
mesh term: Spinal Stenosis
mesh term: Constriction, Pathologic