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Low-level Laser Therapy in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02944760
Recruitment Status : Unknown
Verified October 2016 by Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Irmandade Santa Casa de Misericórdia de Porto Alegre
Information provided by (Responsible Party):
Rodrigo Della Méa Plentz, 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.


Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Other: Low-Level Light Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acute Effects of Low-level Laser Therapy in Functional Capacity of Patients With Chronic Kidney Disease: Randomized Clinical Trial
Study Start Date : March 2016
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Laser Therapy, Low-Level




Primary Outcome Measures :
  1. Functional capacity [ Time Frame: 15 minutes after intervention ]
    Assessed by the change in distance walked in six-minute walk test (6MWT)


Secondary Outcome Measures :
  1. Pain in lower limbs [ Time Frame: 15 minutes after intervention and 15 minutes after of 6MWT ]
    Assessed by change in visual analog scale

  2. Dyspnea [ Time Frame: 15 minutes after intervention and 15 minutes after of 6MWT ]
    Assessed by change in Borg scale

  3. Level of physical activity [ Time Frame: 30 minutes before of intervention ]
    Assessed by questionnaire IPAQ.

  4. Oxidative stress will be assessed through blood collection and analysis of biochemical markers, such as creatine kinase, lactate and Oxygen-reactive species [ Time Frame: 30 minutes before and 30 minutes after intervention ]
    Analysis of changes in biochemical markers, such as creatine kinase, lactate and oxygen-reactive species

  5. DNA damage [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944760


Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Irmandade Santa Casa de Misericórdia de Porto Alegre
Investigators
Principal Investigator: Rodrigo DM Plentz, PhD Federal University of Health Sciences of Porto Alegre

Responsible Party: Rodrigo Della Méa Plentz, PhD, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT02944760     History of Changes
Other Study ID Numbers: LLLT/CKD
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases