<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/NCT03787589</url>
  </required_header>
  <id_info>
    <org_study_id>618</org_study_id>
    <nct_id>NCT03787589</nct_id>
  </id_info>
  <brief_title>Exercise in Patients With End Stage Kidney Disease</brief_title>
  <official_title>A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</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>
      This study will be conducted over a 3 year time period. This is a trial of an exercise&#xD;
      intervention vs. standard of care in patients receiving chronic dialysis. The specific aims&#xD;
      will be to determine feasibility of patient recruitment, adherence to the exercise program,&#xD;
      and efficacy of the intervention on patient important outcomes.&#xD;
&#xD;
      The exercise intervention will be delivered to randomized participants for 12 months, and&#xD;
      consist of the prescribed use of Nordic Walking poles, online resources for exercise in the&#xD;
      home, regular use of a pedometer to monitor progress, and regular verbal encouragement to&#xD;
      exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care&#xD;
      co-interventions including individualized dialysis prescriptions and health-care interactions&#xD;
      according to practices at their centre.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Anticipated">September 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2023</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>Recruitment Feasibility</measure>
    <time_frame>30 months</time_frame>
    <description>The investigators will assess at each centre the number of participants receiving dialysis, approached for participation, eligible to participate and any reasons for non-participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence</measure>
    <time_frame>12 months</time_frame>
    <description>Two-week step counts with a pedometer will be monitored monthly in the treatment group, and at baseline, 6 and 12 months in the control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hand Grip Strength</measure>
    <time_frame>12 months</time_frame>
    <description>The investigators will measure hand grip strength at baseline, 6, and 12 months using a handgrip dynamometer in the dominant hand or in the non-arteriovenous fistula arm (best of two efforts in kgs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life using Vitality Subscale</measure>
    <time_frame>12 months</time_frame>
    <description>Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>12 months</time_frame>
    <description>Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>12 months</time_frame>
    <description>The number of hospitalizations per patient year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>12 months</time_frame>
    <description>Average number of days spent in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Living Status</measure>
    <time_frame>12 months</time_frame>
    <description>Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of the Exercise Program</measure>
    <time_frame>12 months</time_frame>
    <description>Safety will be measured by monitoring serious adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Renal Failure</condition>
  <arm_group>
    <arm_group_label>Exercise Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive standard of care along with the exercise prescription intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Prescription</intervention_name>
    <description>Participants in the intervention group will be given an exercise prescription to increase their baseline steps by 1200 and 2000 steps per day at least 3 days a week over the first 3 months. If tolerated and accepted, the participants will increase their step counts by an additional 600 to 1000 steps per day at least 3 days a week for the next 3 months.This will be followed by a 6-month maintenance phase. The research coordinator will instruct the participants on the proper use of the Nordic walking poles which can be used to help participants achieve their prescribed number of steps.&#xD;
All participants will be encouraged to wear the pedometer throughout the trial in order to follow the step-count prescription and monitor adherence.</description>
    <arm_group_label>Exercise Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All ambulatory adult patients with end stage kidney disease&#xD;
&#xD;
          2. Treatment with peritoneal dialysis or hemodialysis for greater than six months&#xD;
&#xD;
          3. Able to understand English or French&#xD;
&#xD;
          4. Abuse to use Nordic Walking poles&#xD;
&#xD;
          5. Able and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any absolute contraindication to exercise [unstable angina, uncontrolled hypertension&#xD;
             (systolic or diastolic blood pressure greater than 180 mmHg (millimeters of mercury)&#xD;
             or greater than 110 mmHg, respectively), deemed not suitable for exercise by the&#xD;
             treating physician]&#xD;
&#xD;
          2. Baseline step count greater than 8000 steps a day&#xD;
&#xD;
          3. Planned living donor kidney transplant&#xD;
&#xD;
          4. Potential for recovery of renal function&#xD;
&#xD;
          5. Patients who feel unsafe using Nordic walking poles in place of their mobility aid&#xD;
&#xD;
          6. Participation in another interventional trial that may affect the results of this&#xD;
             study&#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>Deborah Zimmerman, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Deborah Zimmerman, MD, MSc</last_name>
    <phone>613-738-8400</phone>
    <phone_ext>82534</phone_ext>
    <email>dzimmerman@toh.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 1A2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Deborah Zimmerman, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>October 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal Failure</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>Peritoneal Dialysis</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The study protocol, manual of operations and consent form will be made available by contacting the corresponding author. De-identified patient data will be available from 12 months to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>One year after publication up to 3 years post publication</ipd_time_frame>
    <ipd_access_criteria>researchers with methodologically sound proposals approved by the principal investigator</ipd_access_criteria>
  </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/NCT03787589
org study id: 618
nct id: NCT03787589
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will be conducted over a 3 year time period. This is a trial of an exercise
      intervention vs. standard of care in patients receiving chronic dialysis. The specific aims
      will be to determine feasibility of patient recruitment, adherence to the exercise program,
      and efficacy of the intervention on patient important outcomes.

      The exercise intervention will be delivered to randomized participants for 12 months, and
      consist of the prescribed use of Nordic Walking poles, online resources for exercise in the
      home, regular use of a pedometer to monitor progress, and regular verbal encouragement to
      exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care
      co-interventions including individualized dialysis prescriptions and health-care interactions
      according to practices at their centre.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Recruitment Feasibility
time frame: 30 months
description: The investigators will assess at each centre the number of participants receiving dialysis, approached for participation, eligible to participate and any reasons for non-participation.
measure: Adherence
time frame: 12 months
description: Two-week step counts with a pedometer will be monitored monthly in the treatment group, and at baseline, 6 and 12 months in the control group.
measure: Hand Grip Strength
time frame: 12 months
description: The investigators will measure hand grip strength at baseline, 6, and 12 months using a handgrip dynamometer in the dominant hand or in the non-arteriovenous fistula arm (best of two efforts in kgs)
measure: Quality of Life using Vitality Subscale
time frame: 12 months
description: Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)
measure: Sleep Quality
time frame: 12 months
description: Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
measure: Hospitalizations
time frame: 12 months
description: The number of hospitalizations per patient year
measure: Hospital Length of Stay
time frame: 12 months
description: Average number of days spent in hospital
measure: Change in Living Status
time frame: 12 months
description: Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
measure: Safety of the Exercise Program
time frame: 12 months
description: Safety will be measured by monitoring serious adverse events
arm group label: Exercise Intervention
arm group type: Experimental
description: Participants in this arm will receive standard of care along with the exercise prescription intervention
arm group label: Standard of Care
arm group type: No Intervention
description: This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.
intervention type: Behavioral
intervention name: Exercise Prescription
description: Participants in the intervention group will be given an exercise prescription to increase their baseline steps by 1200 and 2000 steps per day at least 3 days a week over the first 3 months. If tolerated and accepted, the participants will increase their step counts by an additional 600 to 1000 steps per day at least 3 days a week for the next 3 months.This will be followed by a 6-month maintenance phase. The research coordinator will instruct the participants on the proper use of the Nordic walking poles which can be used to help participants achieve their prescribed number of steps.
All participants will be encouraged to wear the pedometer throughout the trial in order to follow the step-count prescription and monitor adherence.
arm group label: Exercise Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Deborah Zimmerman, MD, MSc
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
last name: Deborah Zimmerman, MD, MSc
phone: 613-738-8400
phone ext: 82534
email: dzimmerman@toh.ca
facility: 
status: Recruiting
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
sharing ipd: Yes
ipd description: The study protocol, manual of operations and consent form will be made available by contacting the corresponding author. De-identified patient data will be available from 12 months to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: One year after publication up to 3 years post publication
ipd access criteria: researchers with methodologically sound proposals approved by the principal investigator