Low-level Laser Therapy in Chronic Kidney Disease
Primary Purpose
Kidney Failure, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-Level Light Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Low-Level Light Therapy Group
Placebo Group
Arm Description
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.
The patient was placed supine on a stretcher and the application of laser therapy occured with apparatus off.
Outcomes
Primary Outcome Measures
Functional capacity
Assessed by the change in distance walked in six-minute walk test (6MWT)
Secondary Outcome Measures
Pain in lower limbs
Assessed by change in visual analog scale
Dyspnea
Assessed by change in Borg scale
Level of physical activity
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
Analysis of changes in biochemical markers, such as creatine kinase, lactate and oxygen-reactive species
DNA damage
By electrophoresis single (comet technique), where cells are counted by microscopy and and the breaks will be checked
Full Information
NCT ID
NCT02944760
First Posted
October 11, 2016
Last Updated
October 25, 2016
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02944760
Brief Title
Low-level Laser Therapy in Chronic Kidney Disease
Official Title
Acute Effects of Low-level Laser Therapy in Functional Capacity of Patients With Chronic Kidney Disease: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-Level Light Therapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
The patient was placed supine on a stretcher and the application of laser therapy occured with apparatus off.
Intervention Type
Other
Intervention Name(s)
Low-Level Light Therapy
Other Intervention Name(s)
Laser Therapy, Low-Level
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional capacity
Description
Assessed by the change in distance walked in six-minute walk test (6MWT)
Time Frame
15 minutes after intervention
Secondary Outcome Measure Information:
Title
Pain in lower limbs
Description
Assessed by change in visual analog scale
Time Frame
15 minutes after intervention and 15 minutes after of 6MWT
Title
Dyspnea
Description
Assessed by change in Borg scale
Time Frame
15 minutes after intervention and 15 minutes after of 6MWT
Title
Level of physical activity
Description
Assessed by questionnaire IPAQ.
Time Frame
30 minutes before of intervention
Title
Oxidative stress will be assessed through blood collection and analysis of biochemical markers, such as creatine kinase, lactate and Oxygen-reactive species
Description
Analysis of changes in biochemical markers, such as creatine kinase, lactate and oxygen-reactive species
Time Frame
30 minutes before and 30 minutes after intervention
Title
DNA damage
Description
By electrophoresis single (comet technique), where cells are counted by microscopy and and the breaks will be checked
Time Frame
30 minutes before and 30 minutes after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo DM Plentz, PhD
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Low-level Laser Therapy in Chronic Kidney Disease
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