Kidney Failure, ChronicNCT02944760
Low-level Laser Therapy in Chronic Kidney Disease
A study testing Low-Level Light Therapy in people with Kidney Failure, Chronic, run by Federal University of Health Science of Porto Alegre.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Low-Level Light Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic kidney disease on hemodialysis for more than 3 months;
- Clearance of urea during hemodialysis (Kt/V ≥ 1.2).
Who cannot join
- 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;
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- 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.
About this study
Official title: Acute Effects of Low-level Laser Therapy in Functional Capacity of Patients With Chronic Kidney Disease: Randomized Clinical Trial
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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Low-Level Light Therapy
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Light TherapyOther
Also called Laser Therapy, Low-Level
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Light Therapy Group | Experimental | 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. Receives: Other: Low-Level Light Therapy |
| Placebo Group | Placebo comparator | The patient was placed supine on a stretcher and the application of laser therapy occured with apparatus off. Receives: Other: Low-Level Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Assessed by the change in distance walked in six-minute walk test (6MWT)
Measured: 15 minutes after intervention
Secondary outcomes (5)
Pain in lower limbs
Assessed by change in visual analog scale
Measured: 15 minutes after intervention and 15 minutes after of 6MWT
Dyspnea
Assessed by change in Borg scale
Measured: 15 minutes after intervention and 15 minutes after of 6MWT
Level of physical activity
Assessed by questionnaire IPAQ.
Measured: 30 minutes before of intervention
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
Measured: 30 minutes before and 30 minutes after intervention
DNA damage
By electrophoresis single (comet technique), where cells are counted by microscopy and and the breaks will be checked
Measured: 30 minutes before and 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Responsible party
- Principal investigator, Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre
- Investigators
- Rodrigo DM Plentz, PhD, Principal investigator, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944760
- Sponsor's protocol ID
- LLLT/CKD
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Low-level Laser Therapy in Functional Capacity of Patients With Chronic Kidney Disease: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02944760
- Acronym / sponsor ID
- LLLT/CKD
- Conditions
- Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Level Light Therapy Group | Experimental | Other: Low-Level Light TherapyThe 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 | Placebo comparator | Other: Low-Level Light TherapyThe patient was placed supine on a stretcher and the application of laser therapy occured with apparatus off. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic kidney disease on hemodialysis for more than 3 months;
- Clearance of urea during hemodialysis (Kt/V ≥ 1.2).
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Light TherapyAlso: Laser Therapy, Low-LevelThe 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 | Low-Level Light Therapy Group, Placebo Group |
Primary outcome
Functional capacity
Time frame: 15 minutes after intervention
Assessed by the change in distance walked in six-minute walk test (6MWT)
5 secondary outcomes
Pain in lower limbs
Time frame: 15 minutes after intervention and 15 minutes after of 6MWT
Dyspnea
Time frame: 15 minutes after intervention and 15 minutes after of 6MWT
Level of physical activity
Time frame: 30 minutes before of intervention
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
DNA damage
Time frame: 30 minutes before and 30 minutes after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo DM Plentz, PhD principal investigator
Federal University of Health Sciences of Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Light Therapy in people with Kidney Failure, Chronic, run by Federal University of Health Science of Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: 15 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.