Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure
- Conditions
- Renal Insufficiency, ChronicRenal DialysisClinical TrialLow-Level Light Therapy
- Interventions
- Other: Low Level Laser Therapy
- Registration Number
- NCT03250715
- Lead Sponsor
- Federal University of Health Science of Porto Alegre
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Patients with chronic kidney failure on hemodialysis for more than 3 months;
- Dialysis with weekly frequency of 3 times/week;
- Adequate urea clearance rate during hemodialysis (Kt/V ≥ 1.2 or URR ≥65%).
- Cognitive dysfunction
- Epidermal lesions at the site of laser application
- Patients with active carcinoma
- Patients with recent sequel of stroke (three months)
- Recent myocardium acute infarction (two months)
- Uncontrolled hypertension (SBP> 230 mmHg and DBP> 120 mmHg)
- Grade IV heart failure according to the New York Heart Association or decompensated
- Unstable angina
- Peripheral vascular changes in lower limbs such as deep venous thrombosis
- Disabling osteoarticular or musculoskeletal disease
- Uncontrolled diabetes (glycemia> 300mg/dL)
- Febrile condition and/or infectious disease
- Active smoking.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Level Laser Therapy group Low Level Laser Therapy 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.
- Primary Outcome Measures
Name Time Method Change in DNA Damage Before intervention, after 4 and 8 weeks DNA damage will be assessed by the alkaline comet assay
Change in Functional Capacity Before intervention, after 4 and 8 weeks Functional capacity will be assessed by the Six-Minute Walk Test
- Secondary Outcome Measures
Name Time Method Change in Muscle Strength of Lower Limbs Before intervention, after 4 and 8 weeks Muscle strength of lower limbs will be assessed by dynamometry
Change in Oxidative Stress Before intervention, after 4 and 8 weeks Oxidative stress will be assessed by measurement of oxidative and antioxidant markers
Change in Fatigue of Lower Limbs Fatigue of lower limbs Before intervention, after 4 and 8 weeks 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
Change in Inflammatory Profile Before intervention, after 4 and 8 weeks Inflammatory profile will be assessed by measurement of interleukins and markers of muscle damage
Change in Muscle Architecture Before intervention and after 8 weeks Muscle architecture of quadriceps will be assessed by ultrasonography
Change in Muscle Pain Before intervention, after 4 and 8 weeks Muscle pain will be assessed by analogic visual scale
Change in Quality of Life Before intervention, after 4 and after 8 weeks Quality of life will be assessed by EQ-5D
Trial Locations
- Locations (1)
Federal University of Health Sciences of Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil