<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/NCT01701128</url>
  </required_header>
  <id_info>
    <org_study_id>TTPD-2011</org_study_id>
    <nct_id>NCT01701128</nct_id>
  </id_info>
  <brief_title>The Effect of Exercise Training on Gait and Quality of Life in Parkinson's Disease</brief_title>
  <official_title>The Effect of Exercise Training on Gait and Quality of Life in Patients With Early Parkinson's Disease</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project aims to evaluate the effects of 24 weeks of treadmill training (TT), with and&#xD;
      without a strengthening component, on functional mobility, gait and quality of life in&#xD;
      patients with Parkinson's disease (PD). The rationale for a study of this type stems from the&#xD;
      hypothesis that treadmill training may act as an external &quot;pacemaker&quot; and enhance some&#xD;
      properties of gait. There is a need for larger scale randomized controlled trials comparing&#xD;
      the effects of treadmill training to control groups that receive similar amounts of&#xD;
      attention. To date, no study has combined TT and muscle strengthening, likely the optimal&#xD;
      form of therapy. A kinesiologist supervises the training, 3 times per week, for a total of 72&#xD;
      one-hour exercise sessions. It is hypothesized that at the end of 6 months, treadmill&#xD;
      training will considerably improve walking parameters and the well being of people with PD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Protocol is completed&#xD;
  </why_stopped>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">June 2011</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 (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Gait speed</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This measure was recorded using the GAITrite system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Endurance walking</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This measure was recorded using the 6-minutes walk test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of life</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This measure was recorded using PDQ-39</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Postural Balance</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This measure was recorded using force platform PRO Balance Master®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Spatiotemporal parameters of walking</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This measure was recorded using the GAITrite system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive impairment</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This measure was recorded using Mini-Mental State Examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fear of falling</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This measure was recorded using the ABC Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression and anxiety level</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This measure was recorded using BDI-II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Effects of symptoms and motor impairment</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This measure was recorded using the UPDRS</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Speed TT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Walk on treadmill with progressive increases in speed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mixed TT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Walk on treadmill with progressive increases in speed and incline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Light-intensity exercise group, work flexibility and coordination</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Walking on treadmill</intervention_name>
    <description>3 sessions/week, 24 weeks. The heart rate does not exceed 75% of maximum heart rate (220-age) of the participant and that blood pressure does not exceed 250/115 mmHg. During the first week, the TT velocity was adjusted to 80% of preferential walking speed of the participant. The following week, the participant was encouraged to reach 90% and 100% in the third week. From the fourth week, subjects in the Speed TT had an increase in speed, depending on exercise tolerance of each participant. The TT velocity was increased by 0,2 km/h when the participant reached criteria.</description>
    <arm_group_label>Speed TT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Walking on treadmill</intervention_name>
    <description>3 sessions/week, 24 weeks. The heart rate does not exceed 75% of maximum heart rate (220-age) of the participant and that blood pressure does not exceed 250/115 mmHg. During the first week, the TT velocity was adjusted to 80% of preferential walking speed of the participant. The following week, the participant was encouraged to reach 90% and 100% in the third week. From the fourth week, the TT velocity was increased by 0,2 km/h or the incline of the walking surface of TT was increased by 1% alternately when the progression criteria were met.</description>
    <arm_group_label>Mixed TT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Training of the control group was characterized by light intensity exercises. For the first three months, participants performed regular exercise involving full range of motion to enhance their flexibility. For the last three months of the training programme, participants learned elements of Tai Chi and rhythmic movements of latin dance. Participants attended two 1-h supervised sessions per week and were asked to perform each week a third session at home, based on instructions in a document offered to the control group participants</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of idiopathic Parkinson's disease&#xD;
&#xD;
          -  Stage of II or less on Hoehn and Yahr scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having musculoskeletal impairments or having excessive pain in any joint that could&#xD;
             limit participation in exercise program&#xD;
&#xD;
          -  Dementia (MMSE&lt;24)&#xD;
&#xD;
          -  Having balance problems&#xD;
&#xD;
          -  Live beyond 45 minutes from Laval University&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Corbeil</last_name>
    <role>Study Director</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexandra Nadeau</last_name>
    <role>Study Director</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emmanuelle Pourcher</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quebec Memory and Motor Skills Disorders Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quebec Memory and Motor Skills Disorders Research Center</name>
      <address>
        <city>Quebec</city>
        <zip>G1S 2M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laval University</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 0A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity, treadmill training, rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT01701128
org study id: TTPD-2011
nct id: NCT01701128
lead sponsor: 
has dmc: Yes
The project aims to evaluate the effects of 24 weeks of treadmill training (TT), with and
      without a strengthening component, on functional mobility, gait and quality of life in
      patients with Parkinson's disease (PD). The rationale for a study of this type stems from the
      hypothesis that treadmill training may act as an external "pacemaker" and enhance some
      properties of gait. There is a need for larger scale randomized controlled trials comparing
      the effects of treadmill training to control groups that receive similar amounts of
      attention. To date, no study has combined TT and muscle strengthening, likely the optimal
      form of therapy. A kinesiologist supervises the training, 3 times per week, for a total of 72
      one-hour exercise sessions. It is hypothesized that at the end of 6 months, treadmill
      training will considerably improve walking parameters and the well being of people with PD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in Gait speed
time frame: Baseline, 3 and 6 months
description: This measure was recorded using the GAITrite system
measure: Change in Endurance walking
time frame: Baseline, 3 and 6 months
description: This measure was recorded using the 6-minutes walk test
measure: Change in Quality of life
time frame: Baseline, 3 and 6 months
description: This measure was recorded using PDQ-39
measure: Change in Postural Balance
time frame: Baseline, 3 and 6 months
description: This measure was recorded using force platform PRO Balance Master®
measure: Change in Spatiotemporal parameters of walking
time frame: Baseline, 3 and 6 months
description: This measure was recorded using the GAITrite system
measure: Change in Cognitive impairment
time frame: Baseline, 3 and 6 months
description: This measure was recorded using Mini-Mental State Examination
measure: Change in Fear of falling
time frame: Baseline, 3 and 6 months
description: This measure was recorded using the ABC Scale
measure: Change in Depression and anxiety level
time frame: Baseline, 3 and 6 months
description: This measure was recorded using BDI-II
measure: Change in Effects of symptoms and motor impairment
time frame: Baseline, 3 and 6 months
description: This measure was recorded using the UPDRS
arm group label: Speed TT
arm group type: Experimental
description: Walk on treadmill with progressive increases in speed
arm group label: Mixed TT
arm group type: Experimental
description: Walk on treadmill with progressive increases in speed and incline
arm group label: Control
arm group type: Active Comparator
description: Light-intensity exercise group, work flexibility and coordination
intervention type: Other
intervention name: Walking on treadmill
description: 3 sessions/week, 24 weeks. The heart rate does not exceed 75% of maximum heart rate (220-age) of the participant and that blood pressure does not exceed 250/115 mmHg. During the first week, the TT velocity was adjusted to 80% of preferential walking speed of the participant. The following week, the participant was encouraged to reach 90% and 100% in the third week. From the fourth week, subjects in the Speed TT had an increase in speed, depending on exercise tolerance of each participant. The TT velocity was increased by 0,2 km/h when the participant reached criteria.
arm group label: Speed TT
intervention type: Other
intervention name: Walking on treadmill
description: 3 sessions/week, 24 weeks. The heart rate does not exceed 75% of maximum heart rate (220-age) of the participant and that blood pressure does not exceed 250/115 mmHg. During the first week, the TT velocity was adjusted to 80% of preferential walking speed of the participant. The following week, the participant was encouraged to reach 90% and 100% in the third week. From the fourth week, the TT velocity was increased by 0,2 km/h or the incline of the walking surface of TT was increased by 1% alternately when the progression criteria were met.
arm group label: Mixed TT
intervention type: Other
intervention name: Control group
description: Training of the control group was characterized by light intensity exercises. For the first three months, participants performed regular exercise involving full range of motion to enhance their flexibility. For the last three months of the training programme, participants learned elements of Tai Chi and rhythmic movements of latin dance. Participants attended two 1-h supervised sessions per week and were asked to perform each week a third session at home, based on instructions in a document offered to the control group participants
arm group label: Control
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Philippe Corbeil
role: Study Director
affiliation: Laval University
last name: Alexandra Nadeau
role: Study Director
affiliation: Laval University
last name: Emmanuelle Pourcher
role: Principal Investigator
affiliation: Quebec Memory and Motor Skills Disorders Research Center
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Parkinson Disease