<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/NCT03301987</url>
  </required_header>
  <id_info>
    <org_study_id>ERC_ULE</org_study_id>
    <nct_id>NCT03301987</nct_id>
  </id_info>
  <brief_title>Chronic Kidney Disease &amp; Therapeutic Exercise</brief_title>
  <official_title>Therapeutic Exercise in Patients With Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de León</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de León</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to evaluate the therapeutic exercise effects in patients with&#xD;
      chronic kidney disease. An interventional prospective study is carried out. A sample of 9&#xD;
      patients with chronic kidney disease is recruited. The kidney function (creatinine clearance&#xD;
      as main outcome) is measured at baseline and 1 month after treatment start.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2017</start_date>
  <completion_date type="Actual">December 9, 2017</completion_date>
  <primary_completion_date type="Actual">December 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Kidney function</measure>
    <time_frame>Change from Baseline creatinine clearance at 1 month</time_frame>
    <description>Creatinine clearance</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Kidney</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Therapeutic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic exercise</intervention_name>
    <description>30 minutes per day of therapeutic exercise</description>
    <arm_group_label>Therapeutic exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic kidney disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment and non signed consent inform form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pierre Neyra Bohórquez</name>
      <address>
        <city>Galdakao</city>
        <state>Bizkaia</state>
        <zip>48960</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>December 9, 2017</last_update_submitted>
  <last_update_submitted_qc>December 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de León</investigator_affiliation>
    <investigator_full_name>César Calvo Lobo</investigator_full_name>
    <investigator_title>PhD, MSc, PT</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT03301987
org study id: ERC_ULE
nct id: NCT03301987
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the therapeutic exercise effects in patients with
      chronic kidney disease. An interventional prospective study is carried out. A sample of 9
      patients with chronic kidney disease is recruited. The kidney function (creatinine clearance
      as main outcome) is measured at baseline and 1 month after treatment start.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Kidney function
time frame: Change from Baseline creatinine clearance at 1 month
description: Creatinine clearance
arm group label: Therapeutic exercise
arm group type: Experimental
intervention type: Other
intervention name: Therapeutic exercise
description: 30 minutes per day of therapeutic exercise
arm group label: Therapeutic exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de León
investigator full name: César Calvo Lobo
investigator title: PhD, MSc, PT
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Undecided