Skip to main content
OpenTrials
Completed

NCT Number: NCT03250715

Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Level Laser Therapy

Other

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 names: Low-Level Light Therapy

Primary outcomes

  1. Change in Functional Capacity

    Time frame: Before intervention, after 4 and 8 weeks

    Functional capacity will be assessed by the Six-Minute Walk Test

  2. Change in DNA Damage

    Time frame: Before intervention, after 4 and 8 weeks

    DNA damage will be assessed by the alkaline comet assay

Secondary outcomes

  1. Change in Muscle Strength of Lower Limbs

    Time frame: Before intervention, after 4 and 8 weeks

    Muscle strength of lower limbs will be assessed by dynamometry

  2. Change in Muscle Architecture

    Time frame: Before intervention and after 8 weeks

    Muscle architecture of quadriceps will be assessed by ultrasonography

  3. Change in Muscle Pain

    Time frame: Before intervention, after 4 and 8 weeks

    Muscle pain will be assessed by analogic visual scale

  4. Change in Fatigue of Lower Limbs Fatigue of lower limbs

    Time frame: 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

  5. Change in Oxidative Stress

    Time frame: Before intervention, after 4 and 8 weeks

    Oxidative stress will be assessed by measurement of oxidative and antioxidant markers

  6. Change in Inflammatory Profile

    Time frame: Before intervention, after 4 and 8 weeks

    Inflammatory profile will be assessed by measurement of interleukins and markers of muscle damage

  7. Change in Quality of Life

    Time frame: Before intervention and after 8 weeks

    Quality of life will be assessed by Kidney Disease and Quality-of-Life Short-Form questionnaire

  8. Change in Quality of Life

    Time frame: Before intervention, after 4 and after 8 weeks

    Quality of life will be assessed by EQ-5D

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study title

Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure on Hemodialysis: Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.