<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/NCT02259413</url>
  </required_header>
  <id_info>
    <org_study_id>B2014:088</org_study_id>
    <nct_id>NCT02259413</nct_id>
  </id_info>
  <brief_title>Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis</brief_title>
  <official_title>Effect of an Exercise Rehabilitation Program on Symptom Burden and Quality of Life in Hemodialysis: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Wellness Institute at Seven Oaks General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether participation in a 26-week exercise&#xD;
      rehabilitation program is effective at reducing symptom burden and improving quality of life&#xD;
      in individuals receiving chronic hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals with end-stage kidney disease requiring HD suffer from multiple symptoms, which&#xD;
      have limited effective treatments. Symptom burden, the combined impact of number and severity&#xD;
      of symptoms, negatively impacts functional status and health-related quality of life (HRQOL)&#xD;
      in HD. Small interventional trials suggest exercise can mitigate specific individual&#xD;
      symptoms, but impact of exercise on overall symptom burden in HD is unknown. Dialysis&#xD;
      patients have identified improving symptom burden and HRQOL as research priorities. We&#xD;
      propose the first randomized controlled trial (RCT) investigating the effect of exercise&#xD;
      rehabilitation on symptom burden in individuals on HD.&#xD;
&#xD;
      Hypothesis: In individuals on HD, participation in a 26-week exercise rehabilitation (rehab)&#xD;
      program will reduce symptom burden and improve HRQOL, resulting in reduced disability and&#xD;
      improved long-term clinical outcomes as compared with standard care.&#xD;
&#xD;
      Study Design: Single-centre RCT with one-to-one parallel design, allocation concealment and&#xD;
      assessor blinding&#xD;
&#xD;
      Study Population: Adults receiving chronic in-centre HD for &gt; 3 months with at least one&#xD;
      dialysis-related symptom; n=150&#xD;
&#xD;
      Intervention: Standard care plus 26-week structured rehab program (lifestyle education,&#xD;
      resistance exercise and cycling during HD).&#xD;
&#xD;
      Control: Standard care (baseline exercise counseling)&#xD;
&#xD;
      Outcomes measured at baseline, 12, 26 and 52 weeks.&#xD;
&#xD;
      Data Analysis: Will be performed on an intention to treat, available case basis with t-tests&#xD;
      or Mann Whitney U for continuous outcomes, as per data distribution and Chi square tests for&#xD;
      categorical outcomes. Mixed effects modeling will account for repeated outcome measures over&#xD;
      time. Poisson regression will be performed for hospitalization analysis.&#xD;
&#xD;
      Anticipated Outcomes: Mean symptom burden severity score will decrease by 20% from baseline&#xD;
      in the intervention group at 12 weeks. Due to sustained physical activity in the intervention&#xD;
      group, symptom burden will remain lower in this group at 6 months. In contrast, the control&#xD;
      group will see no improvement in symptom burden from baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">June 8, 2023</completion_date>
  <primary_completion_date type="Actual">June 8, 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>Change in dialysis symptom burden at 12 weeks</measure>
    <time_frame>Measured at study baseline and 12 weeks after study start</time_frame>
    <description>Measured using change in the Dialysis Symptom Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in dialysis symptom burden at 26 and 52 weeks</measure>
    <time_frame>Measured at study baseline, 26 and 52 weeks after study start</time_frame>
    <description>Measured using change in the Dialysis Symptom Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in modified symptom burden</measure>
    <time_frame>Measured at study baseline, 12, 26 and 52 weeks after study start</time_frame>
    <description>Measured using change in modified Dialysis Symptom Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health-related quality of life</measure>
    <time_frame>Measured at study baseline, 12, 26 and 52 weeks after study start</time_frame>
    <description>Measured by self-report using the EuroQol 5D-5L (EQ5D-5L) and EuroQol Visual Analogue Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in time for recovery post-dialysis</measure>
    <time_frame>Measured at study baseline, 12, 26 and 52 weeks after study start</time_frame>
    <description>Measured in minutes with the question &quot;Approximately how much time does it take to recover from a dialysis session&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in endurance/exercise capacity</measure>
    <time_frame>Measured at study baseline, 12, 26 and 52 weeks after study start</time_frame>
    <description>Measured using the Incremental Shuttle Walk Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in frailty status</measure>
    <time_frame>Measured at study baseline, 12, 26 and 52 weeks after study start</time_frame>
    <description>Measured using the Modified Fried Criteria for frailty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy for exercise</measure>
    <time_frame>Measured at study baseline, 12, 26 and 52 weeks after study start</time_frame>
    <description>Measured using the Self-Efficacy for Exercise Survey a 9 item self-reported assessment tool</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in physical activity behaviour pattern</measure>
    <time_frame>Measured at study baseline, 12, 26 and 52 weeks after study start</time_frame>
    <description>Measured in 2 ways:&#xD;
Subjectively using the self-reported Godin-Shephard Leisure Time Physical Activity Questionnaire&#xD;
Objectively using multi-directional accelerometers (Actical Physical Activity Monitors TM) which will be worn for 7 days at each measurement time point&#xD;
2.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospitalization rate</measure>
    <time_frame>Measured at study baseline, 12, 26 and 52 weeks after study start</time_frame>
    <description>Measured by number of hospitalizations and length of stay for each hospitalization</description>
  </other_outcome>
  <other_outcome>
    <measure>Mortality</measure>
    <time_frame>Measured at 1 year after starting dialysis</time_frame>
    <description>Measured as the proportion of people who died during the first year on dialysis</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>End-stage Renal Disease</condition>
  <condition>Renal Failure Chronic Requiring Hemodialysis</condition>
  <arm_group>
    <arm_group_label>Exercise Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive baseline exercise counselling as per Standard Care group. Participants will then participate in a 26-week exercise rehabilitation program incorporating 3 components:&#xD;
One-to-one self-management/resistance education once per week during the first 4 weeks of intervention. Participants will subsequently receive resistance training material to allow for home exercise for the remaining 22 weeks of the intervention.&#xD;
Intradialytic aerobic exercise on a cycle ergometer 3 times weekly for 26 weeks at their usual hemodialysis sessions.&#xD;
Four additional one-to-one standardized education sessions will be completed during the intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive one exercise counseling session as part of their baseline assessment. Participants in the control group will not undergo any other exercise counseling or formal exercise intervention, but will not be prohibited from participating in exercise outside of the study protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Rehabilitation</intervention_name>
    <description>This intervention will consist of lifestyle education, home-based resistance exercise and stationary cycling during hemodialysis sessions. Duration of the intervention will be 26 weeks</description>
    <arm_group_label>Exercise Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  greater than 3 months after starting chronic hemodialysis&#xD;
&#xD;
          -  no planned change in hemodialysis modality or relocation outside of Winnipeg during&#xD;
             study intervention period (26 weeks)&#xD;
&#xD;
          -  assessed to be safe and able to exercise by HD unit nephrologist&#xD;
&#xD;
          -  ability to communicate in English and provide informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute coronary syndrome in past 3 months&#xD;
&#xD;
          -  unstable arrhythmia&#xD;
&#xD;
          -  shortness of breath at rest or with minimal activity (NYHA Class 4)&#xD;
&#xD;
          -  symptomatic hypoglycaemia (&gt; 2x/week in week prior to enrolment)&#xD;
&#xD;
          -  currently participating in the Manitoba Renal Program clinical intradialytic cycling&#xD;
             program&#xD;
&#xD;
          -  score of 0 on Dialysis Symptom Index when administered at time of consent&#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>Clara J Bohm, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seven Oaks General Hospital</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Boniface Hospital</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemodialysis</keyword>
  <keyword>End-stage renal disease</keyword>
  <keyword>Exercise</keyword>
  <keyword>Symptom Burden</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02259413/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02259413/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02259413
org study id: B2014:088
nct id: NCT02259413
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether participation in a 26-week exercise
      rehabilitation program is effective at reducing symptom burden and improving quality of life
      in individuals receiving chronic hemodialysis.
Individuals with end-stage kidney disease requiring HD suffer from multiple symptoms, which
      have limited effective treatments. Symptom burden, the combined impact of number and severity
      of symptoms, negatively impacts functional status and health-related quality of life (HRQOL)
      in HD. Small interventional trials suggest exercise can mitigate specific individual
      symptoms, but impact of exercise on overall symptom burden in HD is unknown. Dialysis
      patients have identified improving symptom burden and HRQOL as research priorities. We
      propose the first randomized controlled trial (RCT) investigating the effect of exercise
      rehabilitation on symptom burden in individuals on HD.

      Hypothesis: In individuals on HD, participation in a 26-week exercise rehabilitation (rehab)
      program will reduce symptom burden and improve HRQOL, resulting in reduced disability and
      improved long-term clinical outcomes as compared with standard care.

      Study Design: Single-centre RCT with one-to-one parallel design, allocation concealment and
      assessor blinding

      Study Population: Adults receiving chronic in-centre HD for > 3 months with at least one
      dialysis-related symptom; n=150

      Intervention: Standard care plus 26-week structured rehab program (lifestyle education,
      resistance exercise and cycling during HD).

      Control: Standard care (baseline exercise counseling)

      Outcomes measured at baseline, 12, 26 and 52 weeks.

      Data Analysis: Will be performed on an intention to treat, available case basis with t-tests
      or Mann Whitney U for continuous outcomes, as per data distribution and Chi square tests for
      categorical outcomes. Mixed effects modeling will account for repeated outcome measures over
      time. Poisson regression will be performed for hospitalization analysis.

      Anticipated Outcomes: Mean symptom burden severity score will decrease by 20% from baseline
      in the intervention group at 12 weeks. Due to sustained physical activity in the intervention
      group, symptom burden will remain lower in this group at 6 months. In contrast, the control
      group will see no improvement in symptom burden from baseline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in dialysis symptom burden at 12 weeks
time frame: Measured at study baseline and 12 weeks after study start
description: Measured using change in the Dialysis Symptom Index
measure: Change in dialysis symptom burden at 26 and 52 weeks
time frame: Measured at study baseline, 26 and 52 weeks after study start
description: Measured using change in the Dialysis Symptom Index
measure: Change in modified symptom burden
time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
description: Measured using change in modified Dialysis Symptom Index
measure: Change in health-related quality of life
time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
description: Measured by self-report using the EuroQol 5D-5L (EQ5D-5L) and EuroQol Visual Analogue Scale.
measure: Change in time for recovery post-dialysis
time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
description: Measured in minutes with the question "Approximately how much time does it take to recover from a dialysis session"
measure: Change in endurance/exercise capacity
time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
description: Measured using the Incremental Shuttle Walk Test
measure: Change in frailty status
time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
description: Measured using the Modified Fried Criteria for frailty.
measure: Change in self-efficacy for exercise
time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
description: Measured using the Self-Efficacy for Exercise Survey a 9 item self-reported assessment tool
measure: Change in physical activity behaviour pattern
time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
description: Measured in 2 ways:
Subjectively using the self-reported Godin-Shephard Leisure Time Physical Activity Questionnaire
Objectively using multi-directional accelerometers (Actical Physical Activity Monitors TM) which will be worn for 7 days at each measurement time point
2.
measure: Hospitalization rate
time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
description: Measured by number of hospitalizations and length of stay for each hospitalization
measure: Mortality
time frame: Measured at 1 year after starting dialysis
description: Measured as the proportion of people who died during the first year on dialysis
arm group label: Exercise Rehabilitation
arm group type: Experimental
description: Participants will receive baseline exercise counselling as per Standard Care group. Participants will then participate in a 26-week exercise rehabilitation program incorporating 3 components:
One-to-one self-management/resistance education once per week during the first 4 weeks of intervention. Participants will subsequently receive resistance training material to allow for home exercise for the remaining 22 weeks of the intervention.
Intradialytic aerobic exercise on a cycle ergometer 3 times weekly for 26 weeks at their usual hemodialysis sessions.
Four additional one-to-one standardized education sessions will be completed during the intervention period.
arm group label: Standard Care
arm group type: No Intervention
description: Participants will receive one exercise counseling session as part of their baseline assessment. Participants in the control group will not undergo any other exercise counseling or formal exercise intervention, but will not be prohibited from participating in exercise outside of the study protocol.
intervention type: Behavioral
intervention name: Exercise Rehabilitation
description: This intervention will consist of lifestyle education, home-based resistance exercise and stationary cycling during hemodialysis sessions. Duration of the intervention will be 26 weeks
arm group label: Exercise Rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clara J Bohm, MD, MPH
role: Principal Investigator
affiliation: University of Manitoba
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
sharing ipd: No
provided document: 
provided document: 