Low-level Laser Therapy in Chronic Kidney Disease

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02944760
• Other study ID #: LLLT/CKD
• Status: Active, not recruiting
• Phase: N/A
• First received: October 11, 2016
• Last updated: October 25, 2016
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Irmandade Santa Casa de Misericórdia de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity	Assessed by the change in distance walked in six-minute walk test (6MWT)	15 minutes after intervention	No
Secondary	Pain in lower limbs	Assessed by change in visual analog scale	15 minutes after intervention and 15 minutes after of 6MWT	No
Secondary	Dyspnea	Assessed by change in Borg scale	15 minutes after intervention and 15 minutes after of 6MWT	No
Secondary	Level of physical activity	Assessed by questionnaire IPAQ.	30 minutes before of intervention	No
Secondary	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	No
Secondary	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	No