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Effects of the Low-level Laser Therapy on Functional Capacity of the Patients With Coronary Artery Bypass Surgery

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ClinicalTrials.gov Identifier: NCT02688426
Recruitment Status : Unknown
Verified March 2016 by Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre.
Recruitment status was:  Recruiting
First Posted : February 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre

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, endurance and functional capacity.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 functional capacity of the patients with Coronary artery bypass surgery.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Device: Sham Low-Level Laser Therapy (Sham LLLT) Device: 6J Low-Level Laser Therapy (6J LLLT) Not Applicable

Detailed Description:
This study will be conducing in a large hospital that is reference in Coronary artery bypass surgery. 15 patients will be randomized for placebo or low-level laser therapy (LLLT). The functional capacity will be test by test six-minute walk test before and after de LLLT. Moreover the application of LBP or placebo will be followed by assessments of muscle damage and oxidative stress. One-week interval between the LLLT will gave to reduce the influence between the treatments.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects Acute of the Low-level Laser Therapy on Functional Capacity on Patients With Coronary Artery Bypass Surgery : A Randomized, Controlled Clinical Trail
Study Start Date : March 2015
Actual Primary Completion Date : February 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: 0J LLLT
The sham treatment is performed in the same way as treatment with LBP, however, with the apparatus switched off
Device: Sham Low-Level Laser Therapy (Sham LLLT)
perform with the machine off
Other Name: Sham LLLT

Device: 6J Low-Level Laser Therapy (6J LLLT)
irradiation will be perform with 6J
Other Name: 6J

Experimental: 6J LLLT
The Laser radiation will be made with 6J by spot.
Device: Sham Low-Level Laser Therapy (Sham LLLT)
perform with the machine off
Other Name: Sham LLLT

Device: 6J Low-Level Laser Therapy (6J LLLT)
irradiation will be perform with 6J
Other Name: 6J




Primary Outcome Measures :
  1. Six-minute walk test [ Time Frame: up to 2 weeks ]

Secondary Outcome Measures :
  1. Muscle damage [ Time Frame: up to 2 weeks ]
    The damage to DNA is analyzed by electrophoresis single (comet technique), where cells are counted by microscopy.

  2. Oxidative stress [ Time Frame: up to 2 weeks ]
    Oxidative stress will be used a measure of tissue damage, the protein oxidation (method of carbonyls) and two defense measures, an enzyme superoxide dismutase and total antioxidant capacity. Oxidative damage (nmol / mg) of protein carbonylation was determined according to the method proposed by Levine & Stadtman, 1990, using whole blood. The enzymatic activity of SOD (SOD / mg protein) was determined by the inhibition of autooxidation of adrenaline measured spectrophotometrically (480nm) under Bannister and Calabrese (1987).



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in the postoperative period of elective CABG referred for cardiac rehabilitation, which are the 15th and 30th days after surgery without ischemic changes and / or complex arrhythmias on the electrocardiogram, between 40 and 75 years of age who have performed the first surgery.

Exclusion Criteria:

  • Patients with decompensated heart failure; presence of any comorbidity such as: unstable angina; associated neurological disease; moderate respiratory illness to severe pre-diagnosed by the attending physician; active infectious disease or fever; disabling peripheral vascular disease; unstable ventricular arrhythmias; diabetes mellitus; use of cardiac pacemaker, musculoskeletal disease that limits physical activity, patients with a BMI ≥30.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688426


Contacts
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Contact: Rodrigo Plentz, PhD +55 51 33038835 roplentz@yahoo.com.br

Locations
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Brazil
Rodrigo Della Méa Plentz Recruiting
Porto Alegre, RS, Brazil, 90050-170
Contact: Rodrigo Della Méa Plentz, PhD    +55 51 33038835    roplentz@yahoo.com.br   
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rodrigo Della Méa Plentz, Clinical Research, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT02688426     History of Changes
Other Study ID Numbers: LLLT-CABG-2016/1
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiovascular Diseases