<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/NCT01674153</url>
  </required_header>
  <id_info>
    <org_study_id>DSRB - 2011/01942</org_study_id>
    <secondary_id>NKFRC/2011/01/06</secondary_id>
    <nct_id>NCT01674153</nct_id>
  </id_info>
  <brief_title>Investigating the Effects of Exercise on Physiological Changes and Toxin Removal in Hemodialysis Patients</brief_title>
  <official_title>A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims&#xD;
      of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of&#xD;
      dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it&#xD;
      is suggested that exercise increases the cardiac output, thus increases the blood flow to&#xD;
      lower extremities. This leads to increased toxin removal from low blood flow regions. On the&#xD;
      other hand, exercise can possibly dilate the vasculature and decrease the compartmental&#xD;
      resistance. In this study, the investigators aim to investigate the exercise induced&#xD;
      physiological changes which enhances the toxin removal. This information combined with&#xD;
      patient specific mathematical models will encourage clinicians to opt for Optimal&#xD;
      intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted&#xD;
      renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin&#xD;
      removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional&#xD;
      hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">July 2014</completion_date>
  <primary_completion_date type="Anticipated">April 2014</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quantify toxin removal</measure>
    <time_frame>6 months</time_frame>
    <description>Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare exercise regimen with HDF</measure>
    <time_frame>6 months</time_frame>
    <description>Compare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Renal Dialysis</condition>
  <arm_group>
    <arm_group_label>HD-Exercise-HDF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intra-dialytic exercise</intervention_name>
    <description>Perform intra-dialytic exercise of three bouts in 4 hours dialysis session. Each patient will perform exercise on Monark 881E rehab trainer (widely used in routine dialysis settings). The exercise intensity will be prescribed based on achievement of 50% of maximum heart rate for each recruited subject.</description>
    <arm_group_label>HD-Exercise-HDF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients male or female (Age &gt; 21 years)&#xD;
&#xD;
          -  Minimum dialysis vintage of 6 months&#xD;
&#xD;
          -  Stable on hemodialysis&#xD;
&#xD;
          -  Minimum Hemoglobin level of 10 g/dL&#xD;
&#xD;
          -  Blood access capable of delivering the blood flow rate greater than 250 mL/min&#xD;
&#xD;
          -  Preserved left ventricular ejection fraction (&gt;50%) on prior imaging study&#xD;
&#xD;
          -  Able to complete a 6min-walk-test without abnormal physiological response, excessive&#xD;
             fatigue, or musculoskeletal discomfort&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of recurring or persistent hypotension in past 3 months&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Severely Hypertensive patients (SBP &gt; 180 mmHg and/or DBP &gt; 115 mmHg)&#xD;
&#xD;
          -  History of recent myocardial infarction or unstable angina (within past 6 months)&#xD;
&#xD;
          -  Significant valvular disease, i.e. severe aortic stenosis and moderate-severe mitral&#xD;
             regurgitation.&#xD;
&#xD;
          -  Patients with end stage organ disease e.g. COPD, recent or debilitating CVA&#xD;
&#xD;
          -  Patient with recent stroke (within past 6 months)&#xD;
&#xD;
          -  Anemic patients&#xD;
&#xD;
          -  History of known arrhythmia&#xD;
&#xD;
          -  Participation in another clinical intervention trial&#xD;
&#xD;
          -  Moderate to severe osteoarthritis of knee(s)&#xD;
&#xD;
          -  Unable to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Titus Lau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Hospital, Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Titus Lau, MD</last_name>
    <phone>+65 6772 4388</phone>
    <phone_ext>4388</phone_ext>
    <email>titus_lau@nuhs.edu.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vaibhav Maheshwari, B.Tech.</last_name>
    <phone>+65 9354 1493</phone>
    <email>vmaheshwari@nus.edu.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dialysis Center, National University of Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Titus Lau, MD</last_name>
      <phone>+65 6772 4388</phone>
      <email>titus_lau@nuhs.edu.sg</email>
    </contact>
    <investigator>
      <last_name>Titus Lau, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Vaithilingam I, Polkinghorne KR, Atkins RC, Kerr PG. Time and exercise improve phosphate removal in hemodialysis patients. Am J Kidney Dis. 2004 Jan;43(1):85-9. doi: 10.1053/j.ajkd.2003.09.016.</citation>
    <PMID>14712431</PMID>
  </reference>
  <results_reference>
    <citation>Ward RA, Greene T, Hartmann B, Samtleben W. Resistance to intercompartmental mass transfer limits beta2-microglobulin removal by post-dilution hemodiafiltration. Kidney Int. 2006 Apr;69(8):1431-7. doi: 10.1038/sj.ki.5000048.</citation>
    <PMID>16395268</PMID>
  </results_reference>
  <results_reference>
    <citation>Maheshwari V, Samavedham L, Rangaiah GP. A regional blood flow model for beta2-microglobulin kinetics and for simulating intra-dialytic exercise effect. Ann Biomed Eng. 2011 Dec;39(12):2879-90. doi: 10.1007/s10439-011-0383-5. Epub 2011 Aug 30. Erratum In: Ann Biomed Eng. 2012 May;40(5):1205.</citation>
    <PMID>21877220</PMID>
  </results_reference>
  <results_reference>
    <citation>Parsons TL, Toffelmire EB, King-VanVlack CE. Exercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil. 2006 May;87(5):680-7. doi: 10.1016/j.apmr.2005.12.044.</citation>
    <PMID>16635631</PMID>
  </results_reference>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>April 1, 2014</last_update_submitted>
  <last_update_submitted_qc>April 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intra-dialytic exercise</keyword>
  <keyword>Toxin removal</keyword>
  <keyword>Hemodiafiltration</keyword>
  <keyword>Inter-compartmental resistance</keyword>
  <keyword>Cardiac output</keyword>
  <!-- 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/NCT01674153
org study id: DSRB - 2011/01942
secondary id: NKFRC/2011/01/06
nct id: NCT01674153
lead sponsor: 
collaborator: 
has dmc: Yes
Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims
      of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of
      dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it
      is suggested that exercise increases the cardiac output, thus increases the blood flow to
      lower extremities. This leads to increased toxin removal from low blood flow regions. On the
      other hand, exercise can possibly dilate the vasculature and decrease the compartmental
      resistance. In this study, the investigators aim to investigate the exercise induced
      physiological changes which enhances the toxin removal. This information combined with
      patient specific mathematical models will encourage clinicians to opt for Optimal
      intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted
      renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin
      removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional
      hemodialysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Quantify toxin removal
time frame: 6 months
description: Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes
measure: Compare exercise regimen with HDF
time frame: 6 months
description: Compare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration
arm group label: HD-Exercise-HDF
arm group type: Experimental
description: Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.
intervention type: Procedure
intervention name: Intra-dialytic exercise
description: Perform intra-dialytic exercise of three bouts in 4 hours dialysis session. Each patient will perform exercise on Monark 881E rehab trainer (widely used in routine dialysis settings). The exercise intensity will be prescribed based on achievement of 50% of maximum heart rate for each recruited subject.
arm group label: HD-Exercise-HDF
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Titus Lau, MD
role: Principal Investigator
affiliation: National University Hospital, Singapore
last name: Titus Lau, MD
phone: +65 6772 4388
phone ext: 4388
email: titus_lau@nuhs.edu.sg
last name: Vaibhav Maheshwari, B.Tech.
phone: +65 9354 1493
email: vmaheshwari@nus.edu.sg
facility: 
status: Recruiting
contact: 
investigator: 
country: Singapore
citation: Vaithilingam I, Polkinghorne KR, Atkins RC, Kerr PG. Time and exercise improve phosphate removal in hemodialysis patients. Am J Kidney Dis. 2004 Jan;43(1):85-9. doi: 10.1053/j.ajkd.2003.09.016.
PMID: 14712431
citation: Ward RA, Greene T, Hartmann B, Samtleben W. Resistance to intercompartmental mass transfer limits beta2-microglobulin removal by post-dilution hemodiafiltration. Kidney Int. 2006 Apr;69(8):1431-7. doi: 10.1038/sj.ki.5000048.
PMID: 16395268
citation: Maheshwari V, Samavedham L, Rangaiah GP. A regional blood flow model for beta2-microglobulin kinetics and for simulating intra-dialytic exercise effect. Ann Biomed Eng. 2011 Dec;39(12):2879-90. doi: 10.1007/s10439-011-0383-5. Epub 2011 Aug 30. Erratum In: Ann Biomed Eng. 2012 May;40(5):1205.
PMID: 21877220
citation: Parsons TL, Toffelmire EB, King-VanVlack CE. Exercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil. 2006 May;87(5):680-7. doi: 10.1016/j.apmr.2005.12.044.
PMID: 16635631
responsible party type: Sponsor