NCT02586376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

October 5, 2015

Last Update Submit

February 2, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle Strength (Handgrip Test)

    once a week throughout 4 weeks

Study Arms (4)

0J LLLT

SHAM COMPARATOR

The intervention will be made with the machine off.

Device: 0J LLLT

4J LLLT

EXPERIMENTAL

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

Device: 4J LLLT

6J LLLT

EXPERIMENTAL

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

Device: 6J LLLT

8J LLLT

EXPERIMENTAL

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

Device: 8J LLLT

Interventions

0J LLLTDEVICE

Sham Low-Level Laser Therapy (Sham LLLT): perform with the machine off.

Also known as: Sham LLLT
0J LLLT
4J LLLTDEVICE

4J Low-Level Laser Therapy (4J LLLT) irradiation will be perform with 4J.

Also known as: 4J
4J LLLT
6J LLLTDEVICE

6J Low-Level Laser Therapy (6J LLLT) irradiation will be perform with 6J.

Also known as: 6J
6J LLLT
8J LLLTDEVICE

8J Low-Level Laser Therapy (8J LLLT) irradiation will be perform with 8J.

Also known as: 8J
8J LLLT

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fabrício Edler Macagnan

Porto Alegre, Rio Grande do Sul, 90.470-140, Brazil

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fabrício E. Macagnan, PhD

    Universidade Federal de Ciências da Saúde

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 26, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations