Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure
Condition: Low-Level Light Therapy; Renal Insufficiency, Chronic; Renal Dialysis; Clinical Trial
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Low Level Laser Therapy
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): Low-Level Light Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment