Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF) (LLLTMSKF)

February 2, 2016 updated by: Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90.470-140
        • Fabricio Edler Macagnan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic kidney failure,
  • long time hemodialysis treatment (>18 months)

Exclusion Criteria:

  • any health disturbance that can reduces the handgrip test performance beyond to the produced by the chronic kidney failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6J LLLT
The Laser radiation will be made with 6J by spot.
Device: 6J LLLT
6J Low-Level Laser Therapy (6J LLLT) irradiation will be perform with 6J.
Other Names:
  • 6J
Sham Comparator: 0J LLLT
The intervention will be made with the machine off.
Device: 0J LLLT
Sham Low-Level Laser Therapy (Sham LLLT): perform with the machine off.
Other Names:
  • Sham LLLT
Experimental: 4J LLLT
The Laser radiation will be made with 4J by spot.
Device: 4J LLLT
4J Low-Level Laser Therapy (4J LLLT) irradiation will be perform with 4J.
Other Names:
  • 4J
Experimental: 8J LLLT
The Laser radiation will be made with 8J by spot.
Device: 8J LLLT
8J Low-Level Laser Therapy (8J LLLT) irradiation will be perform with 8J.
Other Names:
  • 8J

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle Strength (Handgrip Test)
Time Frame: once a week throughout 4 weeks
once a week throughout 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Investigators

  • Principal Investigator: Fabrício E. Macagnan, PhD, Universidade Federal de Ciências da Saúde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLLT-RENAIS-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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