<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/NCT02966600</url>
  </required_header>
  <id_info>
    <org_study_id>UOviedo</org_study_id>
    <nct_id>NCT02966600</nct_id>
  </id_info>
  <brief_title>Strength Training and Different Subtypes of Parkinson´s Disease</brief_title>
  <official_title>Effects of Progressive Resistance Exercise in Akinetic-rigid Parkinson's Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oviedo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oviedo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized controlled trial was to assess the impact of progressive&#xD;
      resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The&#xD;
      investigators hypothesized the intervention would have a beneficial effect on the study&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty-eight patients with PD AR-type of both sexes, were recruited for this trial. Each&#xD;
      participant were assigned randomly to either intervention (N=13) or control (N=15) group.&#xD;
&#xD;
      The intervention group participated in sixteen PRE training sessions for eight weeks: two&#xD;
      sessions per week on non-consecutive days, sixty-seventy min each one. The control group&#xD;
      followed their usual weekly physical activity routine.&#xD;
&#xD;
      All patients underwent antrophometrical and neuromuscular function assessment (CoP&#xD;
      measurements -primary outcomes- and the Ten-Meters Walk Test -TMWT- -secondary outcomes-). In&#xD;
      addition, they were asked to provide ratings for the Spanish validated versions of the the&#xD;
      Freezing of Gait Questionnaire (FOG-Q, 6-item version) -secondary outcomes-, the 39-item&#xD;
      Parkinson ́s disease Questionnaire (PDQ39) -secondary outcomes- and the MDS-UPDRS -secondary&#xD;
      outcomes-. Additionally, ratings of perceived exertion (RPE) (Borg &gt;6-20 scale) - secondary&#xD;
      outcomes-, were recorded at the end of each PRE training session. Tests were carried out at&#xD;
      three times: pre-test (before the training program), post-test (eight weeks after pre-tests,&#xD;
      at the end of the training period), and four weeks after the post-test (re-test).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Static posturography through the centre of pressures measurements (CoP).</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait.</measure>
    <time_frame>Eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freezing of gait.</measure>
    <time_frame>Eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Movement Disorders Society-Unified Parkinson ́s Disease Rating Scale. (MDS-UPDRS).</measure>
    <time_frame>Eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The patient- perceived quality of life.</measure>
    <time_frame>Eight weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Progressive resistance exercise (PRE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Progressive resistance exercise (PRE) in akinetic-rigid Parkinson's disease patients. Intervention included sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Activity</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group followed its usual weekly physical activity routine</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Progressive resistance exercise</intervention_name>
    <description>The intervention group participated in sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one.</description>
    <arm_group_label>Progressive resistance exercise (PRE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Activity</intervention_name>
    <description>The control group followed its usual weekly physical activity routine</description>
    <arm_group_label>Progressive resistance exercise (PRE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with PD AR-type and Hoehn and Yahr Scale 1-2, (H&amp;Y)&#xD;
&#xD;
          -  Do not express any type of dementia&#xD;
&#xD;
          -  Able to stand for two min without assistance;&#xD;
&#xD;
          -  Able to walk ten metres without assistance.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  To suffer a neurological disease other than PD.&#xD;
&#xD;
          -  Do not meet some of the inclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis Santos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University School of Sports Medicine, University of Oviedo, Spain. Performance and Health Group, Department of Physical Education and Sport. Faculty of Sports Sciences and Physical Education, University of A Coruna, Spain.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University School of Sports Medicine, University of Oviedo, Spain.</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 14, 2016</last_update_submitted>
  <last_update_submitted_qc>November 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oviedo</investigator_affiliation>
    <investigator_full_name>Luis Santos</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>Parkinson Disease</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/NCT02966600
org study id: UOviedo
nct id: NCT02966600
lead sponsor: 
has dmc: Yes
The aim of this randomized controlled trial was to assess the impact of progressive
      resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The
      investigators hypothesized the intervention would have a beneficial effect on the study
      outcomes.
Twenty-eight patients with PD AR-type of both sexes, were recruited for this trial. Each
      participant were assigned randomly to either intervention (N=13) or control (N=15) group.

      The intervention group participated in sixteen PRE training sessions for eight weeks: two
      sessions per week on non-consecutive days, sixty-seventy min each one. The control group
      followed their usual weekly physical activity routine.

      All patients underwent antrophometrical and neuromuscular function assessment (CoP
      measurements -primary outcomes- and the Ten-Meters Walk Test -TMWT- -secondary outcomes-). In
      addition, they were asked to provide ratings for the Spanish validated versions of the the
      Freezing of Gait Questionnaire (FOG-Q, 6-item version) -secondary outcomes-, the 39-item
      Parkinson ́s disease Questionnaire (PDQ39) -secondary outcomes- and the MDS-UPDRS -secondary
      outcomes-. Additionally, ratings of perceived exertion (RPE) (Borg >6-20 scale) - secondary
      outcomes-, were recorded at the end of each PRE training session. Tests were carried out at
      three times: pre-test (before the training program), post-test (eight weeks after pre-tests,
      at the end of the training period), and four weeks after the post-test (re-test).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Static posturography through the centre of pressures measurements (CoP).
time frame: Eight weeks
measure: Gait.
time frame: Eight weeks
measure: Freezing of gait.
time frame: Eight weeks
measure: The Movement Disorders Society-Unified Parkinson ́s Disease Rating Scale. (MDS-UPDRS).
time frame: Eight weeks
measure: The patient- perceived quality of life.
time frame: Eight weeks
arm group label: Progressive resistance exercise (PRE)
arm group type: Experimental
description: Progressive resistance exercise (PRE) in akinetic-rigid Parkinson's disease patients. Intervention included sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one.
arm group label: Physical Activity
arm group type: No Intervention
description: The control group followed its usual weekly physical activity routine
intervention type: Other
intervention name: Progressive resistance exercise
description: The intervention group participated in sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one.
arm group label: Progressive resistance exercise (PRE)
intervention type: Other
intervention name: Physical Activity
description: The control group followed its usual weekly physical activity routine
arm group label: Progressive resistance exercise (PRE)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Luis Santos, PhD
role: Principal Investigator
affiliation: University School of Sports Medicine, University of Oviedo, Spain. Performance and Health Group, Department of Physical Education and Sport. Faculty of Sports Sciences and Physical Education, University of A Coruna, Spain.
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Oviedo
investigator full name: Luis Santos
investigator title: PhD
mesh term: Parkinson Disease
sharing ipd: Undecided