Clinical Trial, Low-Level Light Therapy, Renal Dialysis, Renal Insufficiency, Chronic
Conditions
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.
Interventions
OTHERLow Level Laser Therapy
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.
Sponsors
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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%).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Capacity | Before intervention, after 4 and 8 weeks | Functional capacity will be assessed by the Six-Minute Walk Test |
| Change in DNA Damage | Before intervention, after 4 and 8 weeks | DNA damage will be assessed by the alkaline comet assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Pain | Before intervention, after 4 and 8 weeks | Muscle pain will be assessed by analogic visual scale |
| 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 Muscle Strength of Lower Limbs | Before intervention, after 4 and 8 weeks | Muscle strength of lower limbs will be assessed by dynamometry |
| 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 Quality of Life | Before intervention and after 8 weeks | Quality of life will be assessed by Kidney Disease and Quality-of-Life Short-Form questionnaire |
| 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 Muscle Architecture | Before intervention and after 8 weeks | Muscle architecture of quadriceps will be assessed by ultrasonography |
Countries
Brazil
Outcome results
None listed