<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/NCT02222402</url>
  </required_header>
  <id_info>
    <org_study_id>NIHR HTA Project Ref 12/23/09</org_study_id>
    <nct_id>NCT02222402</nct_id>
  </id_info>
  <brief_title>PrEscription of Intra-Dialytic Exercise to Improve quAlity of Life in Patients With Chronic Kidney Disease</brief_title>
  <acronym>PEDAL</acronym>
  <official_title>Evaluating the Clinical and Cost-effectiveness of Intra-dialytic Exercise for the Improvement of Health-related Quality of Life in People With Stage 5 Chronic Kidney Disease Undergoing Maintenance Haemodialysis Renal Replacement Therapy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College Hospital NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PEDAL study aims to evaluate the effectiveness of a 9-month intradialytic exercise&#xD;
      training intervention designed to improve quality of life (QOL) and alleviate functional&#xD;
      limitations in patients with stage 5 Chronic Kidney Disease (CKD) who are on haemodialysis.&#xD;
      Exercise rehabilitation will be compared against established treatment options available&#xD;
      within UK NHS haemodialysis (HD) units. A qualitative substudy will also investigate the&#xD;
      experience and acceptability of the intervention for both participants and members of the&#xD;
      renal care team. In addition, we want to examine whether this type of additional exercise&#xD;
      treatment is cost effective within the health service setting.&#xD;
&#xD;
      PEDAL is designed as a multi centre randomised clinical trial (RCT) and will recruit 380&#xD;
      adult patients who have been on HD for at least 3 months, from 10 HD sites located in&#xD;
      Scotland, England and Wales. The type of exercise programming will consist of cycling&#xD;
      exercise performed during each dialysis session plus a muscle conditioning programme&#xD;
      performed twice per week. All exercise sessions will be supervised by a physiotherapy&#xD;
      assistant. The exercise prescription will be individualised for all patients on the basis of&#xD;
      their fitness and clinical status.&#xD;
&#xD;
      The main objective is to examine the impact of exercise rehabilitation on quality of life and&#xD;
      well being of patients. We hypothesise that the exercise training delivered during&#xD;
      haemodialysis treatment will significantly improve the functional limitations/abilities of&#xD;
      the patients leading to the detection of clinically beneficial improvement in quality of life&#xD;
      outcome, as measured by the KDQOL-36 physical composite score (PCS) at the primary end point.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</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 from basline in quality of life on the Kidney Disease QOL questionnaire Physical Composite Score (KDQOL-PCS) at month 6.</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>The KDQOL is a disease-specific quality of life measure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">335</enrollment>
  <condition>End-Stage Kidney Disease</condition>
  <arm_group>
    <arm_group_label>INTRA-DIALYTIC EXERCISE TRAINING</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using a modified cycle ergometer, aerobic exercise will be performed in a semi-recumbent position, 3 times per week during the first two hours of haemodialysis. The initial prescription will be set in the moderate intensity range of 40-60% of peak aerobic capacity, progressing to 75% level by the end of the intervention.&#xD;
Twice per week patients will also complete lower extremity muscular conditioning exercise, using ankle weights, after the aerobic cycling exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HAEMODIALYSIS RENAL REPLACEMENT THERAPY</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Haemodialysis is the most common dialysis (renal replacement) treatment for kidney failure.&#xD;
They may also receive dietary advice, counselling, input from social workers, and other forms of educational support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>INTRA-DIALYTIC EXERCISE TRAINING</intervention_name>
    <arm_group_label>INTRA-DIALYTIC EXERCISE TRAINING</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Prevalent Stage 5 CKD patients (GFR &lt;15 mL/min) receiving maintenance haemodialysis&#xD;
             therapy for more than 3 months&#xD;
&#xD;
          2. Male or female&#xD;
&#xD;
          3. Aged &gt;18 years&#xD;
&#xD;
          4. Able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unlikely to be on HD for &gt; 6 months - (this includes cachectic patients,&#xD;
             those with severe heart failure, patients in whom dialysis withdrawal is being&#xD;
             considered, and patients likely to receive a live-donor transplant or transfer to PD&#xD;
             in that period of time);&#xD;
&#xD;
          2. Less than 3 months after the initiation of haemodialysis (patients in this time-frame&#xD;
             are generally less clinically stable, many having vascular access procedures&#xD;
             performed, and rates of inter-current events, including death and hospitalisation, are&#xD;
             very much higher in the first 3 months after commencement of chronic haemodialysis);&#xD;
&#xD;
          3. Deemed to be clinically unstable by treating physician;&#xD;
&#xD;
          4. Dementia or severe cognitive impairment (as will be unable to give consent and/or&#xD;
             complete questionnaire assessments);&#xD;
&#xD;
          5. Severe psychiatric disorders - except treated stable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iain Macdougall</last_name>
    <role>Study Chair</role>
    <affiliation>Kings College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kings College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Exercise</keyword>
  <keyword>Functional Capacity</keyword>
  <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>
    <mesh_term>Kidney Failure, Chronic</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/NCT02222402
org study id: NIHR HTA Project Ref 12/23/09
nct id: NCT02222402
lead sponsor: 
collaborator: 
has dmc: Yes
The PEDAL study aims to evaluate the effectiveness of a 9-month intradialytic exercise
      training intervention designed to improve quality of life (QOL) and alleviate functional
      limitations in patients with stage 5 Chronic Kidney Disease (CKD) who are on haemodialysis.
      Exercise rehabilitation will be compared against established treatment options available
      within UK NHS haemodialysis (HD) units. A qualitative substudy will also investigate the
      experience and acceptability of the intervention for both participants and members of the
      renal care team. In addition, we want to examine whether this type of additional exercise
      treatment is cost effective within the health service setting.

      PEDAL is designed as a multi centre randomised clinical trial (RCT) and will recruit 380
      adult patients who have been on HD for at least 3 months, from 10 HD sites located in
      Scotland, England and Wales. The type of exercise programming will consist of cycling
      exercise performed during each dialysis session plus a muscle conditioning programme
      performed twice per week. All exercise sessions will be supervised by a physiotherapy
      assistant. The exercise prescription will be individualised for all patients on the basis of
      their fitness and clinical status.

      The main objective is to examine the impact of exercise rehabilitation on quality of life and
      well being of patients. We hypothesise that the exercise training delivered during
      haemodialysis treatment will significantly improve the functional limitations/abilities of
      the patients leading to the detection of clinically beneficial improvement in quality of life
      outcome, as measured by the KDQOL-36 physical composite score (PCS) at the primary end point.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from basline in quality of life on the Kidney Disease QOL questionnaire Physical Composite Score (KDQOL-PCS) at month 6.
time frame: Baseline, 6 months
description: The KDQOL is a disease-specific quality of life measure.
arm group label: INTRA-DIALYTIC EXERCISE TRAINING
arm group type: Experimental
description: Using a modified cycle ergometer, aerobic exercise will be performed in a semi-recumbent position, 3 times per week during the first two hours of haemodialysis. The initial prescription will be set in the moderate intensity range of 40-60% of peak aerobic capacity, progressing to 75% level by the end of the intervention.
Twice per week patients will also complete lower extremity muscular conditioning exercise, using ankle weights, after the aerobic cycling exercise.
arm group label: HAEMODIALYSIS RENAL REPLACEMENT THERAPY
arm group type: No Intervention
description: Haemodialysis is the most common dialysis (renal replacement) treatment for kidney failure.
They may also receive dietary advice, counselling, input from social workers, and other forms of educational support.
intervention type: Behavioral
intervention name: INTRA-DIALYTIC EXERCISE TRAINING
arm group label: INTRA-DIALYTIC EXERCISE TRAINING
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Iain Macdougall
role: Study Chair
affiliation: Kings College Hospital
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic