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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02586376
Other study ID # LLLT-RENAIS-2015
Secondary ID
Status Completed
Phase N/A
First received October 5, 2015
Last updated February 2, 2016
Start date October 2015
Est. completion date February 2016

Study information

Verified date February 2016
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date February 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Device:
0J LLLT
Sham Low-Level Laser Therapy (Sham LLLT): perform with the machine off.
4J LLLT
4J Low-Level Laser Therapy (4J LLLT) irradiation will be perform with 4J.
6J LLLT
6J Low-Level Laser Therapy (6J LLLT) irradiation will be perform with 6J.
8J LLLT
8J Low-Level Laser Therapy (8J LLLT) irradiation will be perform with 8J.

Locations

Country Name City State
Brazil Fabrício Edler Macagnan Porto Alegre RS

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Strength (Handgrip Test) once a week throughout 4 weeks No
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