Chronic Kidney FailureLLLTMSKFNCT02586376
Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF)
A study testing 0J LLLT, 4J LLLT and 6J LLLT in people with Chronic Kidney Failure, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The low-level laser therapy (LLLT) has been used in many inflammatory disorders. More recently the LLLT was associated with an improvement in the muscle strength and endurance. But, these effects were described only in health or athletic individuals. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- 0J LLLT, 4J LLLT and 6J LLLT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Feb 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic kidney failure,
- long time hemodialysis treatment (>18 months)
Who cannot join
- any health disturbance that can reduces the handgrip test performance beyond to the produced by the chronic kidney failure.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fabrício Edler Macagnan
Porto Alegre, Rio Grande do Sul, 90.470-140
About this study
Official title: Effects of the Different Intensities of the Low-level Laser Therapy on Handgrip Test on Patients With Kidneys Failure: A Randomized, Controlled Clinical Trail
The low-level laser therapy (LLLT) has been used in many inflammatory disorders. More recently the LLLT was associated with an improvement in the muscle strength and endurance. But, these effects were described only in health or athletic individuals. In this randomized and controlled clinical trails, the investigators will study the effects of LLLT on muscle strength of the patients with kidneys failure on long time hemodialysis treatment. Additionally, investigators will explore three different intensities up the muscle strength.
Read the detailed description
This study will be conducing in a large hospital that is reference in kidneys disorders treatments. 16 patients will be randomized for placebo, 4J, 6J, or 8J low-level laser therapy (LLLT). The maximal voluntary contraction (MVC) will be test by handgrip test before and after de LLLT. One-week interval between the LLLT will gave to reduce the influence between the treatments. Moreover the endurance test will be use to evaluate the muscle oxidation impact of the LLLT.
- Conditions
- Chronic Kidney Failure
- Being tested
- 0J LLLT, 4J LLLT, 6J LLLT, 8J LLLT
- 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.
0J LLLTDevice
Also called Sham LLLT
Sham Low-Level Laser Therapy (Sham LLLT): perform with the machine off.
4J LLLTDevice
Also called 4J
4J Low-Level Laser Therapy (4J LLLT) irradiation will be perform with 4J.
6J LLLTDevice
Also called 6J
6J Low-Level Laser Therapy (6J LLLT) irradiation will be perform with 6J.
8J LLLTDevice
Also called 8J
8J Low-Level Laser Therapy (8J LLLT) irradiation will be perform with 8J.
| Study group | Role | What they receive |
|---|---|---|
| 0J LLLT | Sham comparator | The intervention will be made with the machine off. Receives: Device: 0J LLLT |
| 4J LLLT | Experimental | The Laser radiation will be made with 4J by spot. Receives: Device: 4J LLLT |
| 6J LLLT | Experimental | The Laser radiation will be made with 6J by spot. Receives: Device: 6J LLLT |
| 8J LLLT | Experimental | The Laser radiation will be made with 8J by spot. Receives: Device: 8J LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength (Handgrip Test)
Measured: once a week throughout 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre
- Investigators
- Fabrício E. Macagnan, PhD, Principal investigator, Universidade Federal de Ciências da Saúde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586376
- Sponsor's protocol ID
- LLLT-RENAIS-2015
- Acronym
- LLLTMSKF
- Status last verified
- Feb 2016
- First submitted
- 5 Oct 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Different Intensities of the Low-level Laser Therapy on Handgrip Test on Patients With Kidneys Failure: A Randomized, Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT02586376
- Acronym / sponsor ID
- LLLTMSKF / LLLT-RENAIS-2015
- Conditions
- Chronic Kidney Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Oct 2015 (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.
The low-level laser therapy (LLLT) has been used in many inflammatory disorders. More recently the LLLT was associated with an improvement in the muscle strength and endurance. But, these effects were described only in health or athletic individuals. In this randomized and controlled clinical trails, the investigators will study the effects of LLLT on muscle strength of the patients with kidneys failure on long time hemodialysis treatment. Additionally, investigators will explore three different intensities up the muscle strength.
Detailed description
This study will be conducing in a large hospital that is reference in kidneys disorders treatments. 16 patients will be randomized for placebo, 4J, 6J, or 8J low-level laser therapy (LLLT). The maximal voluntary contraction (MVC) will be test by handgrip test before and after de LLLT. One-week interval between the LLLT will gave to reduce the influence between the treatments. Moreover the endurance test will be use to evaluate the muscle oxidation impact of the LLLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0J LLLT | Sham comparator | Device: 0J LLLTThe intervention will be made with the machine off. |
| 4J LLLT | Experimental | Device: 4J LLLTThe Laser radiation will be made with 4J by spot. |
| 6J LLLT | Experimental | Device: 6J LLLTThe Laser radiation will be made with 6J by spot. |
| 8J LLLT | Experimental | Device: 8J LLLTThe Laser radiation will be made with 8J by spot. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- chronic kidney failure,
- long time hemodialysis treatment (>18 months)
Key exclusion criteria (1 listed)
- any health disturbance that can reduces the handgrip test performance beyond to the produced by the chronic kidney failure.
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 |
|---|---|---|
| 0J LLLTAlso: Sham LLLTSham Low-Level Laser Therapy (Sham LLLT): perform with the machine off. | Device | 0J LLLT |
| 4J LLLTAlso: 4J4J Low-Level Laser Therapy (4J LLLT) irradiation will be perform with 4J. | Device | 4J LLLT |
| 6J LLLTAlso: 6J6J Low-Level Laser Therapy (6J LLLT) irradiation will be perform with 6J. | Device | 6J LLLT |
| 8J LLLTAlso: 8J8J Low-Level Laser Therapy (8J LLLT) irradiation will be perform with 8J. | Device | 8J LLLT |
Primary outcome
Muscle Strength (Handgrip Test)
Time frame: once a week throughout 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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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.
Fabrício E. Macagnan, PhD principal investigator
Universidade Federal de Ciências da Saúde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0J LLLT, 4J LLLT and 6J LLLT in people with Chronic Kidney Failure, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle Strength (Handgrip Test) (time frame: once a week throughout 4 weeks). 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 3 Feb 2016.