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

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250715
• Other study ID #: LLLT_CKF_HD
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2020
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 31, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Trial
• Kidney Failure, Chronic
• Low-Level Light Therapy
• Renal Dialysis
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Low 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.

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional Capacity	Functional capacity will be assessed by the Six-Minute Walk Test	Before intervention, after 4 and 8 weeks
Primary	Change in DNA Damage	DNA damage will be assessed by the alkaline comet assay	Before intervention, after 4 and 8 weeks
Secondary	Change in Muscle Strength of Lower Limbs	Muscle strength of lower limbs will be assessed by dynamometry	Before intervention, after 4 and 8 weeks
Secondary	Change in Muscle Architecture	Muscle architecture of quadriceps will be assessed by ultrasonography	Before intervention and after 8 weeks
Secondary	Change in Muscle Pain	Muscle pain will be assessed by analogic visual scale	Before intervention, after 4 and 8 weeks
Secondary	Change in Fatigue of Lower Limbs Fatigue of lower limbs	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	Before intervention, after 4 and 8 weeks
Secondary	Change in Oxidative Stress	Oxidative stress will be assessed by measurement of oxidative and antioxidant markers	Before intervention, after 4 and 8 weeks
Secondary	Change in Inflammatory Profile	Inflammatory profile will be assessed by measurement of interleukins and markers of muscle damage	Before intervention, after 4 and 8 weeks
Secondary	Change in Quality of Life	Quality of life will be assessed by Kidney Disease and Quality-of-Life Short-Form questionnaire	Before intervention and after 8 weeks
Secondary	Change in Quality of Life	Quality of life will be assessed by EQ-5D	Before intervention, after 4 and after 8 weeks