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

NCT03250715 | Completed DMC

• 1 other identifier: LLLT_CKF_HD
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Low-Level Light Therapy; Renal Insufficiency, Chronic; Renal Dialysis; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Change in Functional Capacity

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

  Before intervention, after 4 and 8 weeks

• Change in DNA Damage

  DNA damage will be assessed by the alkaline comet assay

  Before intervention, after 4 and 8 weeks

Secondary Outcomes (8)

• Change in Muscle Strength of Lower Limbs

  Before intervention, after 4 and 8 weeks

• Change in Muscle Architecture

  Before intervention and after 8 weeks

• Change in Muscle Pain

  Before intervention, after 4 and 8 weeks

• Change in Fatigue of Lower Limbs Fatigue of lower limbs

  Before intervention, after 4 and 8 weeks

• Change in Oxidative Stress

  Before intervention, after 4 and 8 weeks

Study Arms (2)

Low Level Laser Therapy group

EXPERIMENTAL

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.

Other: Low Level Laser Therapy

Control group

NO INTERVENTION

This group will receive no intervention. This group will be evaluated before the intervention, after four and eight weeks of follow up.

Interventions

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.

Also known as: Low-Level Light Therapy

Low Level Laser Therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

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

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Rodrigo DM Plentz, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 16, 2017
• Study Start: September 1, 2017
• Primary Completion: February 2, 2018
• Study Completion: August 31, 2018
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

BR (1)