<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/NCT01721551</url>
  </required_header>
  <id_info>
    <org_study_id>UTH2-3/10-10-2012</org_study_id>
    <nct_id>NCT01721551</nct_id>
  </id_info>
  <brief_title>Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention</brief_title>
  <acronym>StandFirm</acronym>
  <official_title>Phase 4 Exercise Training in Aspects of Fatigue in Patients Receiving Dialysis Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Greek Ministry of Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Larissa University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Thessaly</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the current study is to investigate whether changes in patients' sleep quality&#xD;
      and quantity will be followed by improvements in parameters related to physical and mental&#xD;
      fatigue in patients receiving hemodialysis therapy.&#xD;
&#xD;
      More specific, the current project will investigate the effect of a 9 months intradialytic&#xD;
      exercise training in aspects related to fatigue, quality of life and depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic renal disease is a &quot;silent epidemic&quot; affecting up to 10% of the population in the EU,&#xD;
      USA, and Asian with some of the sufferers progressing into end-stage renal failure.&#xD;
&#xD;
      Renal disease patients are characterized by progressively worsening muscle weakness and&#xD;
      muscle atrophy due to both a metabolic and a disuse component collectively described as&#xD;
      uremic myopathy. While various interventions in stable HD patients have helped these patients&#xD;
      improve their functionality, they still have not proven enough to bring their muscle quality&#xD;
      and quantity up to the levels of a healthy sedentary person. Moreover, patients present with&#xD;
      sleep problems, neurological and quality of life issues, anxiety and/or symptoms of&#xD;
      depression but most notably they complain of chronic fatigue and &quot;lack of energy&quot;.&#xD;
&#xD;
      Other factors that contribute to the excessive fatigue are a lack of restorative sleep,&#xD;
      excess pre-dialysis weight, poor nutritional status, restless legs syndrome and the overall&#xD;
      mental status of the patients. Evidently, of all of these factors can contribute to a&#xD;
      self-exacerbating process, a vicious circle, of fatigue due to inactivity and further&#xD;
      inactivity due to fatigue. This sensation of an enduring fatigue interferes with physical and&#xD;
      social activities and feeds perceptions of increased restrictions and barriers, and leads to&#xD;
      a significant reduction of physical activity and functional capacity, which in turn&#xD;
      contributes to the increased cardiovascular risk and a high mortality rate among these&#xD;
      patients.&#xD;
&#xD;
      Rationale: The investigators hypothesize that by improving the patients fitness levels, it&#xD;
      will lead in more energy during day and therefore less fatigue. Our mission is to help the HD&#xD;
      patient to better cope with their sensation of fatigue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Levels of Fatigue</measure>
    <time_frame>9 months</time_frame>
    <description>Fatigue will be assessed by direct and indirect measurements. Physical Fatigue will be assessed by hand grip, functional tests, cardiorespiratory max test. Mental Fatigue will be assessed by questionnaires. Cognitive Fatigue will be assessed by questionnaires. Pre and Post dialysis fatigue will be assessed by hand grip and questionnaires.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>9 months</time_frame>
    <description>Muscle composition will be assessed by BCM bio impedance system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Functionality</measure>
    <time_frame>9 months</time_frame>
    <description>Muscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life aspects</measure>
    <time_frame>9 months</time_frame>
    <description>Depression, Quality of life will be assessed by questionnaires. Sleep quality and quantity will be assessed by questionnaires and a full night polysomnography.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac functionality</measure>
    <time_frame>9 months</time_frame>
    <description>Structural and functional characteristics of the heart will be assessed by an ecocardiography system before, during and after hemodialysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Neurological Assessment</measure>
    <time_frame>9 months</time_frame>
    <description>Full neurological assessment will take place</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HD patients will receive a 9 months intradialytic exercise training program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No exercise</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>HD patients will not participate in any type of systematic exercise training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Training will include a 45-60 min aerobic training on a rehabilitation cycle ergometer (Monark Rehab Trainer 881E) in the supine position during dialysis session. The intensity will progress from 30-40% of the maximum exercise power to 60-70%.</description>
    <arm_group_label>Exercise training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Treatment</intervention_name>
    <description>The CON group received no intervention but the usual treatment</description>
    <arm_group_label>No exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult hemodialysis patients both sexes who has received regular HD treatment for at least 6&#xD;
        months, adequate dialysis delivery with Kt/V &gt;1.1 and good compliance with dialysis&#xD;
        treatment, with serum albumin &gt; 2.5 g/dL, hemoglobin&gt;= 11g/dL sleep onset latency &gt; 15&#xD;
        minutes or sleep efficiency &lt; 85% or arousal index &gt; 25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients unable to give informed consent, with opportunistic infection in the last 3&#xD;
        months, malignancy or infection requiring intravenous antibiotics within 2 months prior to&#xD;
        enrollment, myoskeletal contraindication to exercise requirement for systemic&#xD;
        anticoagulation, participating or participated in an investigational drug or medical device&#xD;
        study within 30 days or five half-lives, pregnant, breast feed or female of childbearing&#xD;
        potential who does not agree to remain abstinent or to use an acceptable contraceptive&#xD;
        regimen, lactate dehydrogenase &gt; 300U/L, prolonged heart wave (QT) interval (as defined by&#xD;
        corrected QT (QTc) &gt; 460 msec in males and &gt; 470 msec in females) on screening&#xD;
        electrocardiogram (ECG), known current alcohol or drug abuse, known or suspected&#xD;
        hypersensitivity to the study medication or any of its ingredients,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giorgos K. Sakkas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Research and Technology Thessaly - University of Thessaly</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christina Karatzaferi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Thessaly</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ioannis Stefanidis, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Thessaly</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Larissa</name>
      <address>
        <city>Larissa</city>
        <state>Thessaly</state>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Patsidis General Clinic</name>
      <address>
        <city>Larissa</city>
        <state>Thessaly</state>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Trikala</name>
      <address>
        <city>Trikala</city>
        <state>Thessaly</state>
        <zip>42100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Sakkas GK, Karatzaferi C. Hemodialysis fatigue: just &quot;simple&quot; fatigue or a syndrome on its own right? Front Physiol. 2012 Jul 31;3:306. doi: 10.3389/fphys.2012.00306. eCollection 2012. No abstract available.</citation>
    <PMID>22934057</PMID>
  </reference>
  <reference>
    <citation>Grigoriou SS, Giannaki CD, George K, Karatzaferi C, Zigoulis P, Eleftheriadis T, Stefanidis I, Sakkas GK. A single bout of hybrid intradialytic exercise did not affect left-ventricular function in exercise-naive dialysis patients: a randomized, cross-over trial. Int Urol Nephrol. 2022 Jan;54(1):201-208. doi: 10.1007/s11255-021-02910-x. Epub 2021 Jun 7.</citation>
    <PMID>34100215</PMID>
  </reference>
  <reference>
    <citation>Grigoriou SS, Krase AA, Karatzaferi C, Giannaki CD, Lavdas E, Mitrou GI, Bloxham S, Stefanidis I, Sakkas GK. Long-term intradialytic hybrid exercise training on fatigue symptoms in patients receiving hemodialysis therapy. Int Urol Nephrol. 2021 Apr;53(4):771-784. doi: 10.1007/s11255-020-02711-8. Epub 2021 Jan 2.</citation>
    <PMID>33387217</PMID>
  </reference>
  <reference>
    <citation>Grigoriou SS, Karatzaferi C, Sakkas GK. Pharmacological and Non-pharmacological Treatment Options for Depression and Depressive Symptoms in Hemodialysis Patients. Health Psychol Res. 2015 Apr 13;3(1):1811. doi: 10.4081/hpr.2015.1811. eCollection 2015 Apr 13.</citation>
    <PMID>26973957</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Thessaly</investigator_affiliation>
    <investigator_full_name>Giorgos K. Sakkas</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Dialysis fatigue,</keyword>
  <keyword>exercise intolerance,</keyword>
  <keyword>muscle atrophy,</keyword>
  <keyword>cachexia,</keyword>
  <keyword>disability,</keyword>
  <keyword>Sleep disorders</keyword>
  <keyword>Depression</keyword>
  <keyword>Mental Fatigue,</keyword>
  <keyword>Cognitive function</keyword>
  <keyword>Physical Fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01721551
org study id: UTH2-3/10-10-2012
nct id: NCT01721551
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the current study is to investigate whether changes in patients' sleep quality
      and quantity will be followed by improvements in parameters related to physical and mental
      fatigue in patients receiving hemodialysis therapy.

      More specific, the current project will investigate the effect of a 9 months intradialytic
      exercise training in aspects related to fatigue, quality of life and depression.
Chronic renal disease is a "silent epidemic" affecting up to 10% of the population in the EU,
      USA, and Asian with some of the sufferers progressing into end-stage renal failure.

      Renal disease patients are characterized by progressively worsening muscle weakness and
      muscle atrophy due to both a metabolic and a disuse component collectively described as
      uremic myopathy. While various interventions in stable HD patients have helped these patients
      improve their functionality, they still have not proven enough to bring their muscle quality
      and quantity up to the levels of a healthy sedentary person. Moreover, patients present with
      sleep problems, neurological and quality of life issues, anxiety and/or symptoms of
      depression but most notably they complain of chronic fatigue and "lack of energy".

      Other factors that contribute to the excessive fatigue are a lack of restorative sleep,
      excess pre-dialysis weight, poor nutritional status, restless legs syndrome and the overall
      mental status of the patients. Evidently, of all of these factors can contribute to a
      self-exacerbating process, a vicious circle, of fatigue due to inactivity and further
      inactivity due to fatigue. This sensation of an enduring fatigue interferes with physical and
      social activities and feeds perceptions of increased restrictions and barriers, and leads to
      a significant reduction of physical activity and functional capacity, which in turn
      contributes to the increased cardiovascular risk and a high mortality rate among these
      patients.

      Rationale: The investigators hypothesize that by improving the patients fitness levels, it
      will lead in more energy during day and therefore less fatigue. Our mission is to help the HD
      patient to better cope with their sensation of fatigue.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Levels of Fatigue
time frame: 9 months
description: Fatigue will be assessed by direct and indirect measurements. Physical Fatigue will be assessed by hand grip, functional tests, cardiorespiratory max test. Mental Fatigue will be assessed by questionnaires. Cognitive Fatigue will be assessed by questionnaires. Pre and Post dialysis fatigue will be assessed by hand grip and questionnaires.
measure: Body composition
time frame: 9 months
description: Muscle composition will be assessed by BCM bio impedance system
measure: Muscle Functionality
time frame: 9 months
description: Muscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol.
measure: Quality of life aspects
time frame: 9 months
description: Depression, Quality of life will be assessed by questionnaires. Sleep quality and quantity will be assessed by questionnaires and a full night polysomnography.
measure: Cardiac functionality
time frame: 9 months
description: Structural and functional characteristics of the heart will be assessed by an ecocardiography system before, during and after hemodialysis
measure: Neurological Assessment
time frame: 9 months
description: Full neurological assessment will take place
arm group label: Exercise training
arm group type: Experimental
description: HD patients will receive a 9 months intradialytic exercise training program
arm group label: No exercise
arm group type: Placebo Comparator
description: HD patients will not participate in any type of systematic exercise training
intervention type: Other
intervention name: Exercise
description: Training will include a 45-60 min aerobic training on a rehabilitation cycle ergometer (Monark Rehab Trainer 881E) in the supine position during dialysis session. The intensity will progress from 30-40% of the maximum exercise power to 60-70%.
arm group label: Exercise training
intervention type: Other
intervention name: Usual Treatment
description: The CON group received no intervention but the usual treatment
arm group label: No exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Giorgos K. Sakkas, PhD
role: Principal Investigator
affiliation: Center for Research and Technology Thessaly - University of Thessaly
last name: Christina Karatzaferi, PhD
role: Principal Investigator
affiliation: University of Thessaly
last name: Ioannis Stefanidis, MD, PhD
role: Study Director
affiliation: University of Thessaly
facility: 
facility: 
facility: 
country: Greece
citation: Sakkas GK, Karatzaferi C. Hemodialysis fatigue: just "simple" fatigue or a syndrome on its own right? Front Physiol. 2012 Jul 31;3:306. doi: 10.3389/fphys.2012.00306. eCollection 2012. No abstract available.
PMID: 22934057
citation: Grigoriou SS, Giannaki CD, George K, Karatzaferi C, Zigoulis P, Eleftheriadis T, Stefanidis I, Sakkas GK. A single bout of hybrid intradialytic exercise did not affect left-ventricular function in exercise-naive dialysis patients: a randomized, cross-over trial. Int Urol Nephrol. 2022 Jan;54(1):201-208. doi: 10.1007/s11255-021-02910-x. Epub 2021 Jun 7.
PMID: 34100215
citation: Grigoriou SS, Krase AA, Karatzaferi C, Giannaki CD, Lavdas E, Mitrou GI, Bloxham S, Stefanidis I, Sakkas GK. Long-term intradialytic hybrid exercise training on fatigue symptoms in patients receiving hemodialysis therapy. Int Urol Nephrol. 2021 Apr;53(4):771-784. doi: 10.1007/s11255-020-02711-8. Epub 2021 Jan 2.
PMID: 33387217
citation: Grigoriou SS, Karatzaferi C, Sakkas GK. Pharmacological and Non-pharmacological Treatment Options for Depression and Depressive Symptoms in Hemodialysis Patients. Health Psychol Res. 2015 Apr 13;3(1):1811. doi: 10.4081/hpr.2015.1811. eCollection 2015 Apr 13.
PMID: 26973957
responsible party type: Principal Investigator
investigator affiliation: University of Thessaly
investigator full name: Giorgos K. Sakkas
investigator title: Research Associate Professor
mesh term: Fatigue
sharing ipd: No