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

Primary Purpose

Chronic Kidney Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
0J LLLT
4J LLLT
6J LLLT
8J LLLT
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Failure

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fabrício Edler Macagnan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

0J LLLT

4J LLLT

6J LLLT

8J LLLT

Arm Description

The intervention will be made with the machine off.

The Laser radiation will be made with 4J by spot.

The Laser radiation will be made with 6J by spot.

The Laser radiation will be made with 8J by spot.

Outcomes

Primary Outcome Measures

Muscle Strength (Handgrip Test)

Secondary Outcome Measures

Full Information

First Posted
October 5, 2015
Last Updated
February 2, 2016
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02586376
Brief Title
Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF)
Acronym
LLLTMSKF
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (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

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0J LLLT
Arm Type
Sham Comparator
Arm Description
The intervention will be made with the machine off.
Arm Title
4J LLLT
Arm Type
Experimental
Arm Description
The Laser radiation will be made with 4J by spot.
Arm Title
6J LLLT
Arm Type
Experimental
Arm Description
The Laser radiation will be made with 6J by spot.
Arm Title
8J LLLT
Arm Type
Experimental
Arm Description
The Laser radiation will be made with 8J by spot.
Intervention Type
Device
Intervention Name(s)
0J LLLT
Other Intervention Name(s)
Sham LLLT
Intervention Description
Sham Low-Level Laser Therapy (Sham LLLT): perform with the machine off.
Intervention Type
Device
Intervention Name(s)
4J LLLT
Other Intervention Name(s)
4J
Intervention Description
4J Low-Level Laser Therapy (4J LLLT) irradiation will be perform with 4J.
Intervention Type
Device
Intervention Name(s)
6J LLLT
Other Intervention Name(s)
6J
Intervention Description
6J Low-Level Laser Therapy (6J LLLT) irradiation will be perform with 6J.
Intervention Type
Device
Intervention Name(s)
8J LLLT
Other Intervention Name(s)
8J
Intervention Description
8J Low-Level Laser Therapy (8J LLLT) irradiation will be perform with 8J.
Primary Outcome Measure Information:
Title
Muscle Strength (Handgrip Test)
Time Frame
once a week throughout 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrício E. Macagnan, PhD
Organizational Affiliation
Universidade Federal de Ciências da Saúde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fabrício Edler Macagnan
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90.470-140
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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