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Low-level Laser Therapy in Chronic Kidney Disease

Primary Purpose

Kidney Failure, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-Level Light Therapy
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with chronic kidney disease on hemodialysis for more than 3 months;
  • Clearance of urea during hemodialysis (Kt/V ≥ 1.2).

Exclusion Criteria:

  • Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form;
  • Epidermal lesions at the site of application and/or intolerance stimulator and/or skin sensitivity change;
  • Patients with recent sequel of stroke;
  • Disabling musculoskeletal disease;
  • Uncontrolled hypertension (Systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg);
  • Grade IV heart failure (NYHA) or decompensated;
  • Uncontrolled diabetes (blood glucose > 300 mg/dL);
  • Unstable angina;
  • Fever and/or infectious disease;
  • Recent acute myocardial infarction (two months);
  • Active smokers; Peripheral vascular disease in the lower limbs as deep vein thrombosis or obliterates thromboangiitis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Low-Level Light Therapy Group

    Placebo Group

    Arm Description

    The patient was placed supine on a stretcher and the application will take place with the Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting of five diodes 850 nm and power output of 200 mW. Six points in quadriceps and four points in gastrocnemius, were irradiated, bilaterally, by 30 seconds.

    The patient was placed supine on a stretcher and the application of laser therapy occured with apparatus off.

    Outcomes

    Primary Outcome Measures

    Functional capacity
    Assessed by the change in distance walked in six-minute walk test (6MWT)

    Secondary Outcome Measures

    Pain in lower limbs
    Assessed by change in visual analog scale
    Dyspnea
    Assessed by change in Borg scale
    Level of physical activity
    Assessed by questionnaire IPAQ.
    Oxidative stress will be assessed through blood collection and analysis of biochemical markers, such as creatine kinase, lactate and Oxygen-reactive species
    Analysis of changes in biochemical markers, such as creatine kinase, lactate and oxygen-reactive species
    DNA damage
    By electrophoresis single (comet technique), where cells are counted by microscopy and and the breaks will be checked

    Full Information

    First Posted
    October 11, 2016
    Last Updated
    October 25, 2016
    Sponsor
    Federal University of Health Science of Porto Alegre
    Collaborators
    Irmandade Santa Casa de Misericórdia de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02944760
    Brief Title
    Low-level Laser Therapy in Chronic Kidney Disease
    Official Title
    Acute Effects of Low-level Laser Therapy in Functional Capacity of Patients With Chronic Kidney Disease: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre
    Collaborators
    Irmandade Santa Casa de Misericórdia de Porto Alegre

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney function and in its most advanced stage is called chronic renal failure. Although hemodialysis replace some kidney function, patients suffer some alterations characterized by "uremic syndrome" typically expressed by: motor neuropathy and/or autonomic neuropathy, cardiac or musculoskeletal myopathies, peripheral vascular changes, among others. Thus, the functional capacity and ability to exercise presents diminished these patients. The aim of this study is to verify the acute effect of low level laser therapy on the functional capacity of these individuals. The research will be developed in the hemodialysis unit of the Santa Clara hospital of Santa Casa de Misericordia de Porto Alegre and the patients will be evaluated before and immediately after the application of laser therapy protocol. Before the protocol will be evaluated pain in the lower limbs, Borg scale, level of physical activity through the International Physical Activity Questionnaire (IPAQ) and blood collection will be held for later analysis parameters of biochemical oxidative stress and deoxyribonucleic acid (DNA) damage. The laser therapy protocol will be applied in 6 points in quadriceps and 4 points in the gastrocnemius, bilaterally. After application, will be held the 6-minute walk test, effort subjective perception by Borg scale, assessment of pain in the lower limbs with visual analog scale and a new blood sample for further analysis. Patients will be randomized in two groups. The intervention group (IG), which will be held laser therapy and placebo group (PG), where the laser therapy will be placebo mode applied. The application will take place with the Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting of five diodes 850 nanometers (nm) and power output of 200 milliwatts (mW). It is irradiated 6 points in quadriceps and 4 points in gastrocnemius, bilaterally.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Failure, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-Level Light Therapy Group
    Arm Type
    Experimental
    Arm Description
    The patient was placed supine on a stretcher and the application will take place with the Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting of five diodes 850 nm and power output of 200 mW. Six points in quadriceps and four points in gastrocnemius, were irradiated, bilaterally, by 30 seconds.
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    The patient was placed supine on a stretcher and the application of laser therapy occured with apparatus off.
    Intervention Type
    Other
    Intervention Name(s)
    Low-Level Light Therapy
    Other Intervention Name(s)
    Laser Therapy, Low-Level
    Intervention Description
    The application of laser therapy will take place 30 minutes before the start of dialysis. The application will take place with the Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting of five diodes 850 nm and power output of 200 mW. It is irradiated 6 points in quadriceps and 4 points in gastrocnemius, bilaterally by 30 seconds. The patient will be supine on a stretcher to the implementation of the intervention.
    Primary Outcome Measure Information:
    Title
    Functional capacity
    Description
    Assessed by the change in distance walked in six-minute walk test (6MWT)
    Time Frame
    15 minutes after intervention
    Secondary Outcome Measure Information:
    Title
    Pain in lower limbs
    Description
    Assessed by change in visual analog scale
    Time Frame
    15 minutes after intervention and 15 minutes after of 6MWT
    Title
    Dyspnea
    Description
    Assessed by change in Borg scale
    Time Frame
    15 minutes after intervention and 15 minutes after of 6MWT
    Title
    Level of physical activity
    Description
    Assessed by questionnaire IPAQ.
    Time Frame
    30 minutes before of intervention
    Title
    Oxidative stress will be assessed through blood collection and analysis of biochemical markers, such as creatine kinase, lactate and Oxygen-reactive species
    Description
    Analysis of changes in biochemical markers, such as creatine kinase, lactate and oxygen-reactive species
    Time Frame
    30 minutes before and 30 minutes after intervention
    Title
    DNA damage
    Description
    By electrophoresis single (comet technique), where cells are counted by microscopy and and the breaks will be checked
    Time Frame
    30 minutes before and 30 minutes after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with chronic kidney disease on hemodialysis for more than 3 months; Clearance of urea during hemodialysis (Kt/V ≥ 1.2). Exclusion Criteria: Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form; Epidermal lesions at the site of application and/or intolerance stimulator and/or skin sensitivity change; Patients with recent sequel of stroke; Disabling musculoskeletal disease; Uncontrolled hypertension (Systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg); Grade IV heart failure (NYHA) or decompensated; Uncontrolled diabetes (blood glucose > 300 mg/dL); Unstable angina; Fever and/or infectious disease; Recent acute myocardial infarction (two months); Active smokers; Peripheral vascular disease in the lower limbs as deep vein thrombosis or obliterates thromboangiitis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rodrigo DM Plentz, PhD
    Organizational Affiliation
    Federal University of Health Sciences of Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Low-level Laser Therapy in Chronic Kidney Disease

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