Low-level Laser Therapy in Chronic Kidney Disease

Not Applicable

• Conditions: Kidney Failure, Chronic
• Interventions: Other: Low-Level Light Therapy

• Registration Number: NCT02944760
• Lead Sponsor: Federal University of Health Science of Porto Alegre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-07
• Status Verified: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-25
• Last Update Submitted: 2016-10-25
• Study First Posted: 2016-10-26
• Last Update Posted: 2016-10-26
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Level Light Therapy Group	Low-Level Light Therapy	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.
Placebo Group	Low-Level Light Therapy	The patient was placed supine on a stretcher and the application of laser therapy occured with apparatus off.

Primary Outcome Measures

Name	Time	Method
Functional capacity	15 minutes after intervention	Assessed by the change in distance walked in six-minute walk test (6MWT)

Secondary Outcome Measures

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