Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure
Primary Purpose
Low-Level Light Therapy, Renal Insufficiency, Chronic, Renal Dialysis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low Level Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low-Level Light Therapy
Eligibility Criteria
Inclusion Criteria:
- 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%).
Exclusion Criteria:
- 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.
Sites / Locations
- Federal University of Health Sciences of Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Low Level Laser Therapy group
Control group
Arm Description
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.
This group will receive no intervention. This group will be evaluated before the intervention, after four and eight weeks of follow up.
Outcomes
Primary Outcome Measures
Change in Functional Capacity
Functional capacity will be assessed by the Six-Minute Walk Test
Change in DNA Damage
DNA damage will be assessed by the alkaline comet assay
Secondary Outcome Measures
Change in Muscle Strength of Lower Limbs
Muscle strength of lower limbs will be assessed by dynamometry
Change in Muscle Architecture
Muscle architecture of quadriceps will be assessed by ultrasonography
Change in Muscle Pain
Muscle pain will be assessed by analogic visual scale
Change in Fatigue of Lower Limbs Fatigue of lower limbs
Fatigue of lower limbs will be assessed by Borg's subjective effort perception scale Fatigue of lower limbs will be assessed by Borg's effort perception scale
Change in Oxidative Stress
Oxidative stress will be assessed by measurement of oxidative and antioxidant markers
Change in Inflammatory Profile
Inflammatory profile will be assessed by measurement of interleukins and markers of muscle damage
Change in Quality of Life
Quality of life will be assessed by Kidney Disease and Quality-of-Life Short-Form questionnaire
Change in Quality of Life
Quality of life will be assessed by EQ-5D
Full Information
NCT ID
NCT03250715
First Posted
August 7, 2017
Last Updated
July 28, 2020
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03250715
Brief Title
Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure
Official Title
Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure on Hemodialysis: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 2, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Chronic kidney disease (CKD) consists of kidney damage and progressive and irreversible loss of kidney function and in its later stage (terminal phase) is called chronic kidney failure (CKF). Although hemodialysis (HD) substitutes some of the lost renal functions, patients suffer from some changes that characterize uremic syndrome, such as peripheral motor neuropathy, osteomalacia, cardiac and musculoskeletal myopathies, anemia, among other alterations.
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: a 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.
The expected results at the end of the protocol are: greater distance covered in the walking test; reduction of DNA damage, increase in lower limbs strength; maintenance of muscle mass; reduction of pain and fatigue levels as well as the inflammatory profile and levels of oxidative stress, as well as improvement in the quality of life for the group LLLT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-Level Light Therapy, Renal Insufficiency, Chronic, Renal Dialysis, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Level Laser Therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will receive no intervention. This group will be evaluated before the intervention, after four and eight weeks of follow up.
Intervention Type
Other
Intervention Name(s)
Low Level Laser Therapy
Other Intervention Name(s)
Low-Level Light Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Functional Capacity
Description
Functional capacity will be assessed by the Six-Minute Walk Test
Time Frame
Before intervention, after 4 and 8 weeks
Title
Change in DNA Damage
Description
DNA damage will be assessed by the alkaline comet assay
Time Frame
Before intervention, after 4 and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Muscle Strength of Lower Limbs
Description
Muscle strength of lower limbs will be assessed by dynamometry
Time Frame
Before intervention, after 4 and 8 weeks
Title
Change in Muscle Architecture
Description
Muscle architecture of quadriceps will be assessed by ultrasonography
Time Frame
Before intervention and after 8 weeks
Title
Change in Muscle Pain
Description
Muscle pain will be assessed by analogic visual scale
Time Frame
Before intervention, after 4 and 8 weeks
Title
Change in Fatigue of Lower Limbs Fatigue of lower limbs
Description
Fatigue of lower limbs will be assessed by Borg's subjective effort perception scale Fatigue of lower limbs will be assessed by Borg's effort perception scale
Time Frame
Before intervention, after 4 and 8 weeks
Title
Change in Oxidative Stress
Description
Oxidative stress will be assessed by measurement of oxidative and antioxidant markers
Time Frame
Before intervention, after 4 and 8 weeks
Title
Change in Inflammatory Profile
Description
Inflammatory profile will be assessed by measurement of interleukins and markers of muscle damage
Time Frame
Before intervention, after 4 and 8 weeks
Title
Change in Quality of Life
Description
Quality of life will be assessed by Kidney Disease and Quality-of-Life Short-Form questionnaire
Time Frame
Before intervention and after 8 weeks
Title
Change in Quality of Life
Description
Quality of life will be assessed by EQ-5D
Time Frame
Before intervention, after 4 and after 8 weeks
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 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%).
Exclusion Criteria:
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.
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
Facility Information:
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure
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