<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/NCT03250715</url>
  </required_header>
  <id_info>
    <org_study_id>LLLT_CKF_HD</org_study_id>
    <nct_id>NCT03250715</nct_id>
  </id_info>
  <brief_title>Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure</brief_title>
  <official_title>Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure on Hemodialysis: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Health Science of Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Health Science of Porto Alegre</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 aims to verify the effects of low level laser therapy (LLLT) on functional&#xD;
      capacity, DNA damage, lower limbs muscle strength, quadriceps muscle architecture, muscle&#xD;
      pain and perception of lower limb fatigue, inflammatory profile, oxidative stress and quality&#xD;
      of life of patients with chronic kidney failure on hemodialysis. Patients will be randomized&#xD;
      into two groups: the control group and the LLLT group. The control group will only be&#xD;
      evaluated and reassessed. The LLLT group in addition to the evaluations will receive LLLT&#xD;
      three times a week for eight weeks during HD. The evaluations will be performed&#xD;
      pre-intervention, after 4 and 8 weeks of therapy. However, the muscle architecture evaluation&#xD;
      will be performed only at pre intervention and after 8 weeks.&#xD;
&#xD;
      The evaluations carried out are: six-minute walk test for functional capacity; alkaline comet&#xD;
      assay for DNA damage; sit-and-lift test, and load cell dynamometry for evaluation of lower&#xD;
      limbs muscle strength; quadriceps ultrasonography for muscle architecture and echogenicity;&#xD;
      visual analogue scale for pain; subjective perception of effort by Borg scale for fatigue;&#xD;
      measurement of interleukins 6 and 10, tumor necrosis factor, reative C protein and muscle&#xD;
      damage markers (lactate, creatine kinase) for the inflammatory profile; protein&#xD;
      carbonylation, superoxide dismutase, catalase, total sulfuric acid and dichlorofluorescein&#xD;
      diacetate for oxidative stress and application of the Kidney Disease and&#xD;
      Quality-of-Life-Short-Form and EQ-5D questionnaires for quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic kidney disease (CKD) consists of kidney damage and progressive and irreversible loss&#xD;
      of kidney function and in its later stage (terminal phase) is called chronic kidney failure&#xD;
      (CKF). Although hemodialysis (HD) substitutes some of the lost renal functions, patients&#xD;
      suffer from some changes that characterize uremic syndrome, such as peripheral motor&#xD;
      neuropathy, osteomalacia, cardiac and musculoskeletal myopathies, anemia, among other&#xD;
      alterations.&#xD;
&#xD;
      This study aims to verify the effects of low level laser therapy (LLLT) on functional&#xD;
      capacity, DNA damage, lower limbs muscle strength, quadriceps muscle architecture, muscle&#xD;
      pain and perception of lower limb fatigue, inflammatory profile, oxidative stress and quality&#xD;
      of life of patients with chronic kidney failure on hemodialysis. Patients will be randomized&#xD;
      into two groups: the control group and the LLLT group. The control group will only be&#xD;
      evaluated and reassessed. The LLLT group in addition to the evaluations will receive LLLT&#xD;
      three times a week for eight weeks during HD. The evaluations will be performed&#xD;
      pre-intervention, after 4 and 8 weeks of therapy. However, the muscle architecture evaluation&#xD;
      will be performed only at pre intervention and after 8 weeks.&#xD;
&#xD;
      The evaluations carried out are: a six-minute walk test for functional capacity; alkaline&#xD;
      comet assay for DNA damage; sit-and-lift test, and load cell dynamometry for evaluation of&#xD;
      lower limbs muscle strength; quadriceps ultrasonography for muscle architecture and&#xD;
      echogenicity; visual analogue scale for pain; subjective perception of effort by Borg scale&#xD;
      for fatigue; measurement of interleukins 6 and 10, tumor necrosis factor, reative C protein&#xD;
      and muscle damage markers (lactate, creatine kinase) for the inflammatory profile; protein&#xD;
      carbonylation, superoxide dismutase, catalase, total sulfuric acid and dichlorofluorescein&#xD;
      diacetate for oxidative stress and application of the Kidney Disease and&#xD;
      Quality-of-Life-Short-Form and EQ-5D questionnaires for quality of life.&#xD;
&#xD;
      The expected results at the end of the protocol are: greater distance covered in the walking&#xD;
      test; reduction of DNA damage, increase in lower limbs strength; maintenance of muscle mass;&#xD;
      reduction of pain and fatigue levels as well as the inflammatory profile and levels of&#xD;
      oxidative stress, as well as improvement in the quality of life for the group LLLT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">February 2, 2018</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 Functional Capacity</measure>
    <time_frame>Before intervention, after 4 and 8 weeks</time_frame>
    <description>Functional capacity will be assessed by the Six-Minute Walk Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in DNA Damage</measure>
    <time_frame>Before intervention, after 4 and 8 weeks</time_frame>
    <description>DNA damage will be assessed by the alkaline comet assay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Strength of Lower Limbs</measure>
    <time_frame>Before intervention, after 4 and 8 weeks</time_frame>
    <description>Muscle strength of lower limbs will be assessed by dynamometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Architecture</measure>
    <time_frame>Before intervention and after 8 weeks</time_frame>
    <description>Muscle architecture of quadriceps will be assessed by ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Pain</measure>
    <time_frame>Before intervention, after 4 and 8 weeks</time_frame>
    <description>Muscle pain will be assessed by analogic visual scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fatigue of Lower Limbs Fatigue of lower limbs</measure>
    <time_frame>Before intervention, after 4 and 8 weeks</time_frame>
    <description>Fatigue of lower limbs will be assessed by Borg's subjective effort perception scale Fatigue of lower limbs will be assessed by Borg's effort perception scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Oxidative Stress</measure>
    <time_frame>Before intervention, after 4 and 8 weeks</time_frame>
    <description>Oxidative stress will be assessed by measurement of oxidative and antioxidant markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Inflammatory Profile</measure>
    <time_frame>Before intervention, after 4 and 8 weeks</time_frame>
    <description>Inflammatory profile will be assessed by measurement of interleukins and markers of muscle damage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Before intervention and after 8 weeks</time_frame>
    <description>Quality of life will be assessed by Kidney Disease and Quality-of-Life Short-Form questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Before intervention, after 4 and after 8 weeks</time_frame>
    <description>Quality of life will be assessed by EQ-5D</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Low-Level Light Therapy</condition>
  <condition>Renal Insufficiency, Chronic</condition>
  <condition>Renal Dialysis</condition>
  <condition>Clinical Trial</condition>
  <arm_group>
    <arm_group_label>Low Level Laser Therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six points of application will be defined in the quadriceps and two points of application in the gastrocnemius. The parameters adopted for the irradiation will be: 30 Joules per application point, wavelength of 660 and 850 nm and output power of 200 mW. Each point will be radiated for 30 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive no intervention. This group will be evaluated before the intervention, after four and eight weeks of follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low Level Laser Therapy</intervention_name>
    <description>For application of the LLLT in the quadriceps muscle the patient will be in dorsal decubitus, with the legs extended and will be defined by the palpation of the muscle belts six points of application: two points in the distal region of the vastus medialis muscle, two points of the distal region of the vastus lateral muscle and two points of the central region of the rectus femoris muscle. For the application of LLLT in the gastrocnemius muscle the patient will remain in the supine position, but will be oriented to keep the hips and knees flexed at 90º and 45º respectively. Two application points will be defined, one in the lateral ventricle and the other in the medial ventricle, but both in the distal region of the muscle.</description>
    <arm_group_label>Low Level Laser Therapy group</arm_group_label>
    <other_name>Low-Level Light Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic kidney failure on hemodialysis for more than 3 months;&#xD;
&#xD;
          -  Dialysis with weekly frequency of 3 times/week;&#xD;
&#xD;
          -  Adequate urea clearance rate during hemodialysis (Kt/V ≥ 1.2 or URR ≥65%).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive dysfunction&#xD;
&#xD;
          -  Epidermal lesions at the site of laser application&#xD;
&#xD;
          -  Patients with active carcinoma&#xD;
&#xD;
          -  Patients with recent sequel of stroke (three months)&#xD;
&#xD;
          -  Recent myocardium acute infarction (two months)&#xD;
&#xD;
          -  Uncontrolled hypertension (SBP&gt; 230 mmHg and DBP&gt; 120 mmHg)&#xD;
&#xD;
          -  Grade IV heart failure according to the New York Heart Association or decompensated&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Peripheral vascular changes in lower limbs such as deep venous thrombosis&#xD;
&#xD;
          -  Disabling osteoarticular or musculoskeletal disease&#xD;
&#xD;
          -  Uncontrolled diabetes (glycemia&gt; 300mg/dL)&#xD;
&#xD;
          -  Febrile condition and/or infectious disease&#xD;
&#xD;
          -  Active smoking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo DM Plentz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Health Sciences of Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Health Sciences of Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90050-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Health Science of Porto Alegre</investigator_affiliation>
    <investigator_full_name>Rodrigo Della Méa Plentz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03250715
org study id: LLLT_CKF_HD
nct id: NCT03250715
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to verify the effects of low level laser therapy (LLLT) on functional
      capacity, DNA damage, lower limbs muscle strength, quadriceps muscle architecture, muscle
      pain and perception of lower limb fatigue, inflammatory profile, oxidative stress and quality
      of life of patients with chronic kidney failure on hemodialysis. Patients will be randomized
      into two groups: the control group and the LLLT group. The control group will only be
      evaluated and reassessed. The LLLT group in addition to the evaluations will receive LLLT
      three times a week for eight weeks during HD. The evaluations will be performed
      pre-intervention, after 4 and 8 weeks of therapy. However, the muscle architecture evaluation
      will be performed only at pre intervention and after 8 weeks.

      The evaluations carried out are: six-minute walk test for functional capacity; alkaline comet
      assay for DNA damage; sit-and-lift test, and load cell dynamometry for evaluation of lower
      limbs muscle strength; quadriceps ultrasonography for muscle architecture and echogenicity;
      visual analogue scale for pain; subjective perception of effort by Borg scale for fatigue;
      measurement of interleukins 6 and 10, tumor necrosis factor, reative C protein and muscle
      damage markers (lactate, creatine kinase) for the inflammatory profile; protein
      carbonylation, superoxide dismutase, catalase, total sulfuric acid and dichlorofluorescein
      diacetate for oxidative stress and application of the Kidney Disease and
      Quality-of-Life-Short-Form and EQ-5D questionnaires for quality of life.
Chronic kidney disease (CKD) consists of kidney damage and progressive and irreversible loss
      of kidney function and in its later stage (terminal phase) is called chronic kidney failure
      (CKF). Although hemodialysis (HD) substitutes some of the lost renal functions, patients
      suffer from some changes that characterize uremic syndrome, such as peripheral motor
      neuropathy, osteomalacia, cardiac and musculoskeletal myopathies, anemia, among other
      alterations.

      This study aims to verify the effects of low level laser therapy (LLLT) on functional
      capacity, DNA damage, lower limbs muscle strength, quadriceps muscle architecture, muscle
      pain and perception of lower limb fatigue, inflammatory profile, oxidative stress and quality
      of life of patients with chronic kidney failure on hemodialysis. Patients will be randomized
      into two groups: the control group and the LLLT group. The control group will only be
      evaluated and reassessed. The LLLT group in addition to the evaluations will receive LLLT
      three times a week for eight weeks during HD. The evaluations will be performed
      pre-intervention, after 4 and 8 weeks of therapy. However, the muscle architecture evaluation
      will be performed only at pre intervention and after 8 weeks.

      The evaluations carried out are: a six-minute walk test for functional capacity; alkaline
      comet assay for DNA damage; sit-and-lift test, and load cell dynamometry for evaluation of
      lower limbs muscle strength; quadriceps ultrasonography for muscle architecture and
      echogenicity; visual analogue scale for pain; subjective perception of effort by Borg scale
      for fatigue; measurement of interleukins 6 and 10, tumor necrosis factor, reative C protein
      and muscle damage markers (lactate, creatine kinase) for the inflammatory profile; protein
      carbonylation, superoxide dismutase, catalase, total sulfuric acid and dichlorofluorescein
      diacetate for oxidative stress and application of the Kidney Disease and
      Quality-of-Life-Short-Form and EQ-5D questionnaires for quality of life.

      The expected results at the end of the protocol are: greater distance covered in the walking
      test; reduction of DNA damage, increase in lower limbs strength; maintenance of muscle mass;
      reduction of pain and fatigue levels as well as the inflammatory profile and levels of
      oxidative stress, as well as improvement in the quality of life for the group LLLT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Functional Capacity
time frame: Before intervention, after 4 and 8 weeks
description: Functional capacity will be assessed by the Six-Minute Walk Test
measure: Change in DNA Damage
time frame: Before intervention, after 4 and 8 weeks
description: DNA damage will be assessed by the alkaline comet assay
measure: Change in Muscle Strength of Lower Limbs
time frame: Before intervention, after 4 and 8 weeks
description: Muscle strength of lower limbs will be assessed by dynamometry
measure: Change in Muscle Architecture
time frame: Before intervention and after 8 weeks
description: Muscle architecture of quadriceps will be assessed by ultrasonography
measure: Change in Muscle Pain
time frame: Before intervention, after 4 and 8 weeks
description: Muscle pain will be assessed by analogic visual scale
measure: Change in Fatigue of Lower Limbs Fatigue of lower limbs
time frame: Before intervention, after 4 and 8 weeks
description: Fatigue of lower limbs will be assessed by Borg's subjective effort perception scale Fatigue of lower limbs will be assessed by Borg's effort perception scale
measure: Change in Oxidative Stress
time frame: Before intervention, after 4 and 8 weeks
description: Oxidative stress will be assessed by measurement of oxidative and antioxidant markers
measure: Change in Inflammatory Profile
time frame: Before intervention, after 4 and 8 weeks
description: Inflammatory profile will be assessed by measurement of interleukins and markers of muscle damage
measure: Change in Quality of Life
time frame: Before intervention and after 8 weeks
description: Quality of life will be assessed by Kidney Disease and Quality-of-Life Short-Form questionnaire
measure: Change in Quality of Life
time frame: Before intervention, after 4 and after 8 weeks
description: Quality of life will be assessed by EQ-5D
arm group label: Low Level Laser Therapy group
arm group type: Experimental
description: Six points of application will be defined in the quadriceps and two points of application in the gastrocnemius. The parameters adopted for the irradiation will be: 30 Joules per application point, wavelength of 660 and 850 nm and output power of 200 mW. Each point will be radiated for 30 seconds.
arm group label: Control group
arm group type: No Intervention
description: This group will receive no intervention. This group will be evaluated before the intervention, after four and eight weeks of follow up.
intervention type: Other
intervention name: Low Level Laser Therapy
description: For application of the LLLT in the quadriceps muscle the patient will be in dorsal decubitus, with the legs extended and will be defined by the palpation of the muscle belts six points of application: two points in the distal region of the vastus medialis muscle, two points of the distal region of the vastus lateral muscle and two points of the central region of the rectus femoris muscle. For the application of LLLT in the gastrocnemius muscle the patient will remain in the supine position, but will be oriented to keep the hips and knees flexed at 90º and 45º respectively. Two application points will be defined, one in the lateral ventricle and the other in the medial ventricle, but both in the distal region of the muscle.
arm group label: Low Level Laser Therapy group
other name: Low-Level Light Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rodrigo DM Plentz, PhD
role: Principal Investigator
affiliation: Federal University of Health Sciences of Porto Alegre
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Health Science of Porto Alegre
investigator full name: Rodrigo Della Méa Plentz
investigator title: Principal Investigator
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided