Low-level Laser Therapy in Chronic Kidney Disease

Acute Effects of Low-level Laser Therapy in Functional Capacity of Patients With Chronic Kidney Disease: Randomized Clinical Trial

Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney function and in its most advanced stage is called chronic renal failure. Although hemodialysis replace some kidney function, patients suffer some alterations characterized by "uremic syndrome" typically expressed by: motor neuropathy and/or autonomic neuropathy, cardiac or musculoskeletal myopathies, peripheral vascular changes, among others. Thus, the functional capacity and ability to exercise presents diminished these patients. The aim of this study is to verify the acute effect of low level laser therapy on the functional capacity of these individuals.

The research will be developed in the hemodialysis unit of the Santa Clara hospital of Santa Casa de Misericordia de Porto Alegre and the patients will be evaluated before and immediately after the application of laser therapy protocol. Before the protocol will be evaluated pain in the lower limbs, Borg scale, level of physical activity through the International Physical Activity Questionnaire (IPAQ) and blood collection will be held for later analysis parameters of biochemical oxidative stress and deoxyribonucleic acid (DNA) damage.

The laser therapy protocol will be applied in 6 points in quadriceps and 4 points in the gastrocnemius, bilaterally. After application, will be held the 6-minute walk test, effort subjective perception by Borg scale, assessment of pain in the lower limbs with visual analog scale and a new blood sample for further analysis. Patients will be randomized in two groups. The intervention group (IG), which will be held laser therapy and placebo group (PG), where the laser therapy will be placebo mode applied. The application will take place with the Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting of five diodes 850 nanometers (nm) and power output of 200 milliwatts (mW). It is irradiated 6 points in quadriceps and 4 points in gastrocnemius, bilaterally.

Study Overview

• Status: Unknown
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Other: Low-Level Light Therapy

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with chronic kidney disease on hemodialysis for more than 3 months;
• Clearance of urea during hemodialysis (Kt/V ≥ 1.2).

Exclusion Criteria:

• Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form;
• Epidermal lesions at the site of application and/or intolerance stimulator and/or skin sensitivity change;
• Patients with recent sequel of stroke;
• Disabling musculoskeletal disease;
• Uncontrolled hypertension (Systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg);
• Grade IV heart failure (NYHA) or decompensated;
• Uncontrolled diabetes (blood glucose > 300 mg/dL);
• Unstable angina;
• Fever and/or infectious disease;
• Recent acute myocardial infarction (two months);
• Active smokers; Peripheral vascular disease in the lower limbs as deep vein thrombosis or obliterates thromboangiitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Level Light Therapy Group; The patient was placed supine on a stretcher and the application will take place with the Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting of five diodes 850 nm and power output of 200 mW. Six points in quadriceps and four points in gastrocnemius, were irradiated, bilaterally, by 30 seconds.	Other: Low-Level Light Therapy; The application of laser therapy will take place 30 minutes before the start of dialysis. The application will take place with the Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting of five diodes 850 nm and power output of 200 mW. It is irradiated 6 points in quadriceps and 4 points in gastrocnemius, bilaterally by 30 seconds. The patient will be supine on a stretcher to the implementation of the intervention.; Other Names: Laser Therapy, Low-Level
Placebo Comparator: Placebo Group; The patient was placed supine on a stretcher and the application of laser therapy occured with apparatus off.	Other: Low-Level Light Therapy; The application of laser therapy will take place 30 minutes before the start of dialysis. The application will take place with the Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting of five diodes 850 nm and power output of 200 mW. It is irradiated 6 points in quadriceps and 4 points in gastrocnemius, bilaterally by 30 seconds. The patient will be supine on a stretcher to the implementation of the intervention.; Other Names: Laser Therapy, Low-Level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	Assessed by the change in distance walked in six-minute walk test (6MWT)	15 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain in lower limbs	Assessed by change in visual analog scale	15 minutes after intervention and 15 minutes after of 6MWT
Dyspnea	Assessed by change in Borg scale	15 minutes after intervention and 15 minutes after of 6MWT
Level of physical activity	Assessed by questionnaire IPAQ.	30 minutes before of intervention
Oxidative stress will be assessed through blood collection and analysis of biochemical markers, such as creatine kinase, lactate and Oxygen-reactive species	Analysis of changes in biochemical markers, such as creatine kinase, lactate and oxygen-reactive species	30 minutes before and 30 minutes after intervention
DNA damage	By electrophoresis single (comet technique), where cells are counted by microscopy and and the breaks will be checked	30 minutes before and 30 minutes after intervention

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Irmandade Santa Casa de Misericórdia de Porto Alegre

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: LLLT/CKD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes