<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/NCT02253563</url>
  </required_header>
  <id_info>
    <org_study_id>A 146/11</org_study_id>
    <nct_id>NCT02253563</nct_id>
  </id_info>
  <brief_title>Resistance Versus Balance Training in Parkinson's Disease</brief_title>
  <official_title>Resistance Training Versus Balance Training to Improve Postural Control in Patients With Parkinson's Disease - a Randomized Controlled Rater Blinded Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kiel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kiel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of resistance training versus balance training to improve postural control in&#xD;
      patients with Parkinson's Disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Fullerton Advanced Balance scale</measure>
    <time_frame>up to 2 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Resistance Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group performing resistance training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balance Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group performing balance training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance Training</intervention_name>
    <arm_group_label>Resistance Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Balance Training</intervention_name>
    <arm_group_label>Balance Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  idiopathic Parkinson's Disease, postural instable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiopulmonary/metabolic diseases that could interfere with the safe conduct of the&#xD;
             study protocol, unstable medication, severe cognitive impairments that do not allow&#xD;
             the patients to follow exercise instructions, participation in a resistance or balance&#xD;
             training program (beside usual physical therapy), Deep Brain Stimulation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>May 10, 2016</last_update_submitted>
  <last_update_submitted_qc>May 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kiel</investigator_affiliation>
    <investigator_full_name>Christian Schlenstedt</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>
  <!-- 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/NCT02253563
org study id: A 146/11
nct id: NCT02253563
lead sponsor: 
has dmc: No
Comparison of resistance training versus balance training to improve postural control in
      patients with Parkinson's Disease
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fullerton Advanced Balance scale
time frame: up to 2 years
arm group label: Resistance Training
arm group type: Experimental
description: Group performing resistance training.
arm group label: Balance Training
arm group type: Experimental
description: Group performing balance training.
intervention type: Behavioral
intervention name: Resistance Training
arm group label: Resistance Training
intervention type: Behavioral
intervention name: Balance Training
arm group label: Balance Training
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Kiel
investigator full name: Christian Schlenstedt
investigator title: PhD
mesh term: Parkinson Disease